26 October 2017 EMA/716513/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): fluconazole
Procedure No.: PSUSA/00001404/201703
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
Canesten Thrush Duo Oral Capsule & External Cream 150mg / 2% w/w capsule & cream Diflucan Diflucan Diflucan Diflucan Diflucan 10 mg/ml jauhe oraalisuspensiota varten Diflucan 10 mg/ml pó para suspensão oral Diflucan 10 mg/ml poeder voor orale suspensie Diflucan 10 mg/ml polvere per sospensione orale Diflucan 10 mg/ml polvere per sospensione orale Diflucan 10 mg/ml polvo para suspensión oral Diflucan 10 mg/ml por belsőleges szuszpenzióhoz Diflucan 10 mg/ml poudre pour suspension buvable Diflucan 10 mg/ml poudre pour suspension buvable Diflucan 10 mg/ml powder for oral suspension Diflucan 10 mg/ml powder for oral suspension Diflucan 10 mg/ml prašak za oralnu suspenziju Diflucan 10 mg/ml prašek za peroralno suspenzijo Diflucan 10 mg/ml prašek za peroralno suspenzijo Diflucan 10 mg/ml prašek za peroralno suspenzijo
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available DE/H/3456/004 DE/H/3456/003 DE/H/3456/001 DE/H/3456/005
PL00010/0652 990116 870265 870264 920009
BAYER PLC PFIZER APS PFIZER APS PFIZER APS PFIZER APS
UK IS IS IS IS
DE/H/3456/005
11542
PFIZER OY
FI
DE/H/3456/005
2132181
LABORATÓRIOS PFIZER, LDA.
PT
DE/H/3456/005
BE160422
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/005
027267057
PFIZER ITALIA S.R.L.
IT
DE/H/3456/005
027267119
PFIZER ITALIA S.R.L.
IT
DE/H/3456/005
59.672
VINCIFARMA S.A.
ES
DE/H/3456/005
OGYI-T-1550/07
PFIZER KFT.
HU
DE/H/3456/005
BE160422
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/005
2003097827
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/005
PA 19/44/10
PFIZER LIMITED
IE
DE/H/3456/005
PL 00057/0343
PFIZER LIMITED
UK
not available
UP/I-530-09/11-02/632
PFIZER CROATIA D.O.O.
HR
DE/H/3456/005
H/93/00473/109
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/005
H/93/00473/105
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/005
H/93/00473/107
PFIZER LUXEMBOURG SARL
SI
List of nationally authorised medicinal products EMA/716513/2017
Page 2/32
Product Name (in authorisation country)
Diflucan 10 mg/ml prašek za peroralno suspenzijo Diflucan 10 mg/ml prašek za peroralno suspenzijo Diflucan 10 mg/ml prašek za peroralno suspenzijo Diflucan 10 mg/ml prašek za peroralno suspenzijo Diflucan 10 mg/ml prašek za peroralno suspenzijo Diflucan 10 mg/ml pulbere pentru suspensie orală Diflucan 10 mg/ml pulbere pentru suspensie orală Diflucan 10 mg/ml pulbere pentru suspensie orală Diflucan 10 mg/ml pulbere pentru suspensie orală Diflucan 10 mg/ml pulbere pentru suspensie orală Diflucan 10 mg/ml pulbere pentru suspensie orală Diflucan 10 mg/ml pulver til mikstur, suspensjon Diflucan 10 mg/ml pulver till oral suspension Diflucan 10 mg/ml pulver till oral suspension Diflucan 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen Fluconazol Diflucan 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen Fluconazol Diflucan 10 mg/ml, poeder voor orale suspensie Diflucan 100 mg cápsulas
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/005
H/93/00473/110
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/005
H/93/00473/108
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/005
H/93/00473/106
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/005
H/93/00473/104
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/005
H/93/00473/103
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/005
4067/2011/01
PFIZER EUROPE MA EEIG
RO
DE/H/3456/005
4067/2011/06
PFIZER EUROPE MA EEIG
RO
DE/H/3456/005
4067/2011/02
PFIZER EUROPE MA EEIG
RO
DE/H/3456/005
4067/2011/03
PFIZER EUROPE MA EEIG
RO
DE/H/3456/005
4067/2011/05
PFIZER EUROPE MA EEIG
RO
DE/H/3456/005
4067/2011/04
PFIZER EUROPE MA EEIG
RO
DE/H/3456/005
00/7658
PFIZER AS
NO
DE/H/3456/005
11542
PFIZER OY
FI
DE/H/3456/005
11344
PFIZER AB
SE
DE/H/3456/005
BE160422
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/005
2003097827
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/005 DE/H/3456/002
RVG 15757 4571881
PFIZER B.V. LABORATÓRIOS PFIZER, LDA.
NL PT
List of nationally authorised medicinal products EMA/716513/2017
Page 3/32
Product Name (in authorisation country)
Diflucan 100 mg cápsulas Diflucan 100 mg cápsulas duras Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg capsule rigide Diflucan 100 mg gélules Diflucan 100 mg gélules Diflucan 100 mg hårda kapslar Diflucan 100 mg hårda kapslar Diflucan 100 mg harde capsules Diflucan 100 mg Hartkapseln Fluconazol Diflucan 100 mg Hartkapseln Fluconazol Diflucan 100 mg kapsel, hard Diflucan 100 mg kapsule Diflucan 100 mg kemény kapszula DIFLUCAN 100 mg kietosios kapsulės Diflucan 100 mg kovat kapselit Diflucan 100 mg trde kapsule
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002
2074581 58.804 027267044 027267576 027267588 027267602 027267564 027267590 027267487 027267463 027267549 027267513 027267475 027267525 027267552 027267537 027267451 027267499 027267501 BE253504 2003097824 10045 11155 BE253504
DE/H/3456/002
BE253504
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/002 DE/H/3456/002 not available
2003097824 7599 UP/I-530-09/11-02/630
PFIZER S.A. (BELGIUM) PFIZER AS PFIZER CROATIA D.O.O.
LU NO HR
DE/H/3456/002
OGYI-T-1550/02
PFIZER KFT.
HU
DE/H/3456/006 DE/H/3456/002 DE/H/3456/002
LT/1/96/1923/002 10045 H/93/00473/068
PFIZER LIMITED PFIZER OY PFIZER LUXEMBOURG SARL
LT FI SI
List of nationally authorised medicinal products EMA/716513/2017
LABORATÓRIOS PFIZER, LDA. VINCIFARMA S.A. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER OY PFIZER AB PFIZER S.A. (BELGIUM)
PT ES IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT BE LU FI SE BE
Page 4/32
Product Name (in authorisation country)
Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg trde kapsule Diflucan 100 mg tvrdé kapsuly Diflucan 100 mg Tvrdé tobolky Diflucan 100 mg, capsule, hard
MRP/DCP Authorisation number
DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002 DE/H/3456/002
List of nationally authorised medicinal products EMA/716513/2017
National Authorisation Number
H/93/00473/066 H/93/00473/057 H/93/00473/045 H/93/00473/060 H/93/00473/043 H/93/00473/067 H/93/00473/035 H/93/00473/037 H/93/00473/048 H/93/00473/056 H/93/00473/058 H/93/00473/046 H/93/00473/051 H/93/00473/042 H/93/00473/049 H/93/00473/039 H/93/00473/040 H/93/00473/053 H/93/00473/052 H/93/00473/036 H/93/00473/061 H/93/00473/059 H/93/00473/050 H/93/00473/047 H/93/00473/041 H/93/00473/062 H/93/00473/055 H/93/00473/054 H/93/00473/038 H/93/00473/044 H/93/00473/063 H/93/00473/065 H/93/00473/064 26/0110/12–S 26/121/91 – B/C RVG 14767
MAH of product in the member state
PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER EUROPE MA EEIG PFIZER, SPOL. S R.O. PFIZER B.V.
Member State where product is authorised
SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SK CZ NL
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Product Name (in authorisation country)
Diflucan 150 mg cápsulas Diflucan 150 mg cápsulas Diflucan 150 mg cápsulas Diflucan 150 mg cápsulas duras Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule
MRP/DCP Authorisation number
DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003
List of nationally authorised medicinal products EMA/716513/2017
National Authorisation Number
8692830 8797100 8692822 58.766 5125/2012/01 5125/2012/05 5125/2012/03 5125/2012/02 5125/2012/04 5125/2012/08 5125/2012/12 5125/2012/14 5125/2012/10 5125/2012/11 5125/2012/07 5125/2012/13 5125/2012/06 5125/2012/09 5125/2012/32 5125/2012/30 5125/2012/27 5125/2012/29 5125/2012/21 5125/2012/23 5125/2012/26 5125/2012/15 5125/2012/17 5125/2012/19 5125/2012/25 5125/2012/16 5125/2012/28 5125/2012/18 5125/2012/31 5125/2012/22 5125/2012/24 5125/2012/20
MAH of product in the member state
LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. VINCIFARMA S.A. PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG
Member State where product is authorised
PT PT PT ES RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO
Page 6/32
Product Name (in authorisation country)
Diflucan 150 mg capsule Diflucan 150 mg capsule Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide Diflucan 150 mg capsule rigide
MRP/DCP Authorisation number
DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003
List of nationally authorised medicinal products EMA/716513/2017
National Authorisation Number
5125/2012/33 5125/2012/34 027267020 027267741 027267929 027267931 027267691 027267739 027267715 027267703 027267905 027267727 027267893 027267917 027267677 027267626 027267855 027267640 027267804 027267816 027267830 027267879 027267665 027267842 027267867 027267653 027267689 027267881 027267792 027267638 027267828 027267614 027267780 027267754 027267766 027267778
MAH of product in the member state
PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L.
Member State where product is authorised
RO RO IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT
Page 7/32
Product Name (in authorisation country)
Diflucan 150 mg cietās kapsulas Diflucan 150 mg gélules Diflucan 150 mg gélules Diflucan 150 mg hard capsules Diflucan 150 mg hard Capsules Diflucan 150 mg hårda kapslar Diflucan 150 mg hårda kapslar Diflucan 150 mg harde capsules Diflucan 150 mg Hartkapseln Fluconazol Diflucan 150 mg Hartkapseln Fluconazol Diflucan 150 mg kapsel, hard Diflucan 150 mg kapsule Diflucan 150 mg kemény kapszula Diflucan 150 mg kemény kapszula Diflucan 150 mg kemény kapszula DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003
02-0251 BE253495 2003097825 PA 19/44/2 PL 00057/0290 10020 10898 BE253495
DE/H/3456/003
BE253495
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/003 DE/H/3456/003 not available
2003097825 7600 UP/I-530-09/11-02/631
PFIZER S.A. (BELGIUM) PFIZER AS PFIZER CROATIA D.O.O.
LU NO HR
DE/H/3456/003
OGYI-T-1550/05
PFIZER KFT.
HU
DE/H/3456/003
OGYI-T-1550/04
PFIZER KFT.
HU
DE/H/3456/003
OGYI-T-1550/03
PFIZER KFT.
HU
DE/H/3456/003
LT/1/96/1923/040
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/051
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/003
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/037
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/039
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/044
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/038
PFIZER LIMITED
LT
DE/H/3456/003 DE/H/3456/003
LT/1/96/1923/041 LT/1/96/1923/048
PFIZER LIMITED PFIZER LIMITED
LT LT
List of nationally authorised medicinal products EMA/716513/2017
PFIZER LIMITED PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER LIMITED PFIZER LIMITED PFIZER OY PFIZER AB PFIZER S.A. (BELGIUM)
LV BE LU IE UK FI SE BE
Page 8/32
Product Name (in authorisation country)
kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės DIFLUCAN 150 mg kietosios kapsulės Diflucan 150 mg kovat kapselit Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/003
LT/1/96/1923/043
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/045
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/004
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/042
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/046
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/049
PFIZER LIMITED
LT
DE/H/3456/003
LT/1/96/1923/050
PFIZER LIMITED
LT
DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003
LT/1/96/1923/047 10020 H/93/00473/091 H/93/00473/081 H/93/00473/097 H/93/00473/093 H/93/00473/083 H/93/00473/095 H/93/00473/099 H/93/00473/092 H/93/00473/086 H/93/00473/082 H/93/00473/084 H/93/00473/069 H/93/00473/074 H/93/00473/075 H/93/00473/071 H/93/00473/076 H/93/00473/070 H/93/00473/102
PFIZER LIMITED PFIZER OY PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL
LT FI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI
List of nationally authorised medicinal products EMA/716513/2017
Page 9/32
Product Name (in authorisation country)
Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg trde kapsule Diflucan 150 mg tvrdé kapsuly Diflucan 150 mg Tvrdé tobolky Diflucan 150 mg, capsule, hard Diflucan 150 mg, kõvakapslid Diflucan 2 mg/ml Infusionslösung Fluconazol Diflucan 2 mg/ml Infusionslösung Fluconazol Diflucan 2 mg/ml Infusionslösung Fluconazol Diflucan 2 mg/ml Infusionslösung Fluconazol Diflucan 2 mg/ml Infusionslösung Fluconazol Diflucan 2 mg/ml Infusionslösung Fluconazol Diflucan 2 mg/ml Infusionslösung Fluconazol Diflucan 2 mg/ml Infusionslösung Fluconazol
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003 DE/H/3456/003
H/93/00473/085 H/93/00473/101 H/93/00473/098 H/93/00473/100 H/93/00473/087 H/93/00473/079 H/93/00473/089 H/93/00473/096 H/93/00473/090 H/93/00473/088 H/93/00473/094 H/93/00473/078 H/93/00473/080 H/93/00473/077 H/93/00473/072 H/93/00473/073 26/0111/12–S 26/121/91 – C/C RVG 13039 104595
DE/H/3456/006
BE305426
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE155854
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE444026
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE444035
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE192945
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE305417
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
2003097830
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/006
2003097830
PFIZER S.A. (BELGIUM)
LU
List of nationally authorised medicinal products EMA/716513/2017
PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER EUROPE MA EEIG PFIZER, SPOL. S R.O. PFIZER B.V. PFIZER EUROPE MA EEIG
SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SK CZ NL EE
Page 10/32
Product Name (in authorisation country)
Diflucan 2 mg/ml Infusionslösung Fluconazol Diflucan 2 mg/ml Infusionslösung Fluconazol Diflucan 2 mg/ml infusionsvätska, lösning Diflucan 2 mg/ml infusionsvätska, lösning Diflucan 2 mg/ml infusionsvätska, lösning Diflucan 2 mg/ml infusionsvätska, lösning Diflucan 2 mg/ml infusionsvätska, lösning Diflucan 2 mg/ml infusjonsvæske, oppløsning Diflucan 2 mg/ml infusjonsvæske, oppløsning Diflucan 2 mg/ml infusjonsvæske, oppløsning Diflucan 2 mg/ml infusjonsvæske, oppløsning Diflucan 2 mg/ml infuusioneste, liuos Diflucan 2 mg/ml infuusioneste, liuos Diflucan 2 mg/ml infuusioneste, liuos Diflucan 2 mg/ml infuusioneste, liuos Diflucan 2 mg/ml innrennslislyf, lausn Diflucan 2 mg/ml innrennslislyf, lausn Diflucan 2 mg/ml innrennslislyf, lausn Diflucan 2 mg/ml innrennslislyf,
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/006
2003097830
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/006
2003097830
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/006
10021
PFIZER OY
FI
DE/H/3456/006
10021
PFIZER OY
FI
DE/H/3456/006
10021
PFIZER OY
FI
DE/H/3456/006
10021
PFIZER OY
FI
DE/H/3456/006
11153
PFIZER AB
SE
DE/H/3456/006
7597
PFIZER AS
NO
DE/H/3456/006
7597
PFIZER AS
NO
DE/H/3456/006
7597
PFIZER AS
NO
DE/H/3456/006
7597
PFIZER AS
NO
DE/H/3456/006
10021
PFIZER OY
FI
DE/H/3456/006
10021
PFIZER OY
FI
DE/H/3456/006
10021
PFIZER OY
FI
DE/H/3456/006
10021
PFIZER OY
FI
DE/H/3456/006
890097
PFIZER APS
IS
DE/H/3456/006
890097
PFIZER APS
IS
DE/H/3456/006 DE/H/3456/006
890097 890097
PFIZER APS PFIZER APS
IS IS
List of nationally authorised medicinal products EMA/716513/2017
Page 11/32
Product Name (in authorisation country)
lausn Diflucan 2 mg/ml oldatos infúzió Diflucan 2 mg/ml oldatos infúzió Diflucan 2 mg/ml oldatos infúzió Diflucan 2 mg/ml oldatos infúzió Diflucan 2 mg/ml oplossing voor infusie Diflucan 2 mg/ml oplossing voor infusie Diflucan 2 mg/ml oplossing voor infusie Diflucan 2 mg/ml oplossing voor infusie Diflucan 2 mg/ml oplossing voor infusie Diflucan 2 mg/ml oplossing voor infusie Diflucan 2 mg/ml otopina za infuziju Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/006
OGYI-T-1550/09
PFIZER KFT.
HU
DE/H/3456/006
OGYI-T-1550/09
PFIZER KFT.
HU
DE/H/3456/006
OGYI-T-1550/09
PFIZER KFT.
HU
DE/H/3456/006
OGYI-T-1550/09
PFIZER KFT.
HU
DE/H/3456/006
BE305426
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE444026
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE155854
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE444035
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE192945
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE305417
PFIZER S.A. (BELGIUM)
BE
not available
UP/I-530-09/11-02/633
PFIZER CROATIA D.O.O.
HR
DE/H/3456/006
H/93/00473/127
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/123
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/119
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/120
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/128
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/117
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/124
PFIZER LUXEMBOURG SARL
SI
List of nationally authorised medicinal products EMA/716513/2017
Page 12/32
Product Name (in authorisation country)
Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml raztopina za infundiranje Diflucan 2 mg/ml šķīdums infūzijām Diflucan 2 mg/ml šķīdums infūzijām Diflucan 2 mg/ml šķīdums infūzijām Diflucan 2 mg/ml šķīdums infūzijām Diflucan 2 mg/ml solução para perfusão Diflucan 2 mg/ml solução para perfusão Diflucan 2 mg/ml solução para perfusão Diflucan 2 mg/ml solução para perfusão Diflucan 2 mg/ml solución para perfusión Diflucan 2 mg/ml solución para perfusión Diflucan 2 mg/ml solución para perfusión Diflucan 2 mg/ml solución para perfusión Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/006
H/93/00473/121
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/125
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/122
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/118
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
H/93/00473/126
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/006
96-0660
PFIZER LIMITED
LV
DE/H/3456/006
96-0660
PFIZER LIMITED
LV
DE/H/3456/006
96-0660
PFIZER LIMITED
LV
DE/H/3456/006
96-0660
PFIZER LIMITED
LV
DE/H/3456/006
DE/H/3456/06/MR
LABORATÓRIOS PFIZER, LDA.
PT
DE/H/3456/006
DE/H/3456/06/MR
LABORATÓRIOS PFIZER, LDA.
PT
DE/H/3456/006
8741702
LABORATÓRIOS PFIZER, LDA.
PT
DE/H/3456/006
8741710
LABORATÓRIOS PFIZER, LDA.
PT
DE/H/3456/006
58.817
VINCIFARMA S.A.
ES
DE/H/3456/006
58.817
VINCIFARMA S.A.
ES
DE/H/3456/006
58.817
VINCIFARMA S.A.
ES
DE/H/3456/006
58.817
VINCIFARMA S.A.
ES
DE/H/3456/006 DE/H/3456/006
6166/2014/09 6166/2014/07
PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG
RO RO
List of nationally authorised medicinal products EMA/716513/2017
Page 13/32
Product Name (in authorisation country)
perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml soluţie perfuzabilă Diflucan 2 mg/ml solution for infusion Diflucan 2 mg/ml solution for infusion Diflucan 2 mg/ml solution for infusion Diflucan 2 mg/ml solution pour perfusion Diflucan 2 mg/ml solution pour perfusion Diflucan 2 mg/ml solution pour perfusion Diflucan 2 mg/ml solution pour perfusion Diflucan 2 mg/ml solution pour perfusion
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/006
6166/2014/01
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
6166/2014/06
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
6166/2014/02
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
6166/2014/08
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
6166/2014/03
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
6166/2014/04
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
6166/2014/05
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
6166/2014/10
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
6166/2014/12
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
6166/2014/11
PFIZER EUROPE MA EEIG
RO
DE/H/3456/006
PA 19/44/8
PFIZER LIMITED
IE
DE/H/3456/006
PA 19/044/012
PFIZER LIMITED
IE
DE/H/3456/006
PL 00057/0315
PFIZER LIMITED
UK
DE/H/3456/006
BE444026
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE192945
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE155854
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE305417
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
BE305426
PFIZER S.A. (BELGIUM)
BE
List of nationally authorised medicinal products EMA/716513/2017
Page 14/32
Product Name (in authorisation country)
Diflucan 2 mg/ml solution pour perfusion Diflucan 2 mg/ml solution pour perfusion Diflucan 2 mg/ml solution pour perfusion Diflucan 2 mg/ml solution pour perfusion Diflucan 2 mg/ml solution pour perfusion Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per infusione Diflucan 2 mg/ml soluzione per
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/006
BE444035
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/006
2003097830
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/006
2003097830
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/006
2003097830
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/006
2003097830
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/006
027267032
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
027267071
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
027267083
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
043489172
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
043489133
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
043489158
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
043489184
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
043489160
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
043489145
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
043489119
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
043489121
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006
043489196
PFIZER ITALIA S.R.L.
IT
DE/H/3456/006 DE/H/3456/006
043489210 027267107
PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L.
IT IT
List of nationally authorised medicinal products EMA/716513/2017
Page 15/32
Product Name (in authorisation country)
infusione Diflucan 2 mg/ml, infusioonilahus Diflucan 2 mg/ml, infusioonilahus Diflucan 2 mg/ml, infusioonilahus Diflucan 2 mg/ml, infusioonilahus Diflucan 200 mg cápsulas Diflucan 200 mg cápsulas Diflucan 200 mg cápsulas duras Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg capsule rigide Diflucan 200 mg gélules Diflucan 200 mg gélules Diflucan 200 mg hard capsules Diflucan 200 mg hard capsules Diflucan 200 mg hårda kapslar Diflucan 200 mg harde capsules Diflucan 200 mg Hartkapseln
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/006
109995
PFIZER EUROPE MA EEIG
EE
DE/H/3456/006
109995
PFIZER EUROPE MA EEIG
EE
DE/H/3456/006
109995
PFIZER EUROPE MA EEIG
EE
DE/H/3456/006 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/006 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004 DE/H/3456/004
109995 4571980 2074680 58.803 027267095 043489069 043489071 043489057 043489018 027267982 027267970 027267968 043489020 027267943 043489032 043489044 027267994 027267956 043489107 043489083 043489095 BE253513 2003097826 PA 19/44/04 PL 00057/0317 11156 BE253513 BE253513
PFIZER EUROPE MA EEIG LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. VINCIFARMA S.A. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER LIMITED PFIZER LIMITED PFIZER AB PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM)
EE PT PT ES IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT BE LU IE UK SE BE BE
List of nationally authorised medicinal products EMA/716513/2017
Page 16/32
Product Name (in authorisation country)
Fluconazol Diflucan 200 mg Hartkapseln Fluconazol Diflucan 200 mg kapsel, hard Diflucan 200 mg kemény kapszula Diflucan 200 mg, capsule, hard Diflucan 40 mg/ml jauhe oraalisuspensiota varten Diflucan 40 mg/ml pó para suspensão oral Diflucan 40 mg/ml poeder voor orale suspensie Diflucan 40 mg/ml polvo para suspensión oral Diflucan 40 mg/ml por belsőleges szuszpenzióhoz Diflucan 40 mg/ml poudre pour suspension buvable Diflucan 40 mg/ml poudre pour suspension buvable Diflucan 40 mg/ml powder for oral suspension Diflucan 40 mg/ml powder for oral suspension Diflucan 40 mg/ml prašek za peroralno suspenzijo Diflucan 40 mg/ml prašek za peroralno suspenzijo Diflucan 40 mg/ml prašek za peroralno suspenzijo Diflucan 40 mg/ml prašek za peroralno suspenzijo Diflucan 40 mg/ml prašek za peroralno suspenzijo Diflucan 40 mg/ml prašek za peroralno suspenzijo
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/006 DE/H/3456/004
2003097826 7601
PFIZER S.A. (BELGIUM) PFIZER AS
LU NO
DE/H/3456/004 DE/H/3456/004
OGYI-T-1550/06 RVG 14768
PFIZER KFT. PFIZER B.V.
HU NL
DE/H/3456/008
11543
PFIZER OY
FI
DE/H/3456/008
2132280
LABORATÓRIOS PFIZER, LDA.
PT
DE/H/3456/008
BE160413
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/008
59.673
VINCIFARMA S.A.
ES
DE/H/3456/008
OGYI-T-1550/08
PFIZER KFT.
HU
DE/H/3456/008
BE160413
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/008
2003097828
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/008
PA 19/44/11
PFIZER LIMITED
IE
DE/H/3456/008
PL 00057/0344
PFIZER LIMITED
UK
DE/H/3456/008
H/93/00473/111
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/008
H/93/00473/114
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/008
H/93/00473/113
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/008
H/93/00473/112
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/008
H/93/00473/115
PFIZER LUXEMBOURG SARL
SI
DE/H/3456/008
H/93/00473/116
PFIZER LUXEMBOURG SARL
SI
List of nationally authorised medicinal products EMA/716513/2017
Page 17/32
Product Name (in authorisation country)
Diflucan 40 mg/ml pulver til mikstur, suspensjon Diflucan 40 mg/ml pulver till oral suspension Diflucan 40 mg/ml pulver till oral suspension Diflucan 40 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen Fluconazol Diflucan 40 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen Fluconazol Diflucan 40 mg/ml, poeder voor orale suspensie Diflucan 50 mg cápsulas Diflucan 50 mg cápsulas duras Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/008
00/7659
PFIZER AS
NO
DE/H/3456/008
11543
PFIZER OY
FI
DE/H/3456/008
11345
PFIZER AB
SE
DE/H/3456/008
BE160413
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/008
2003097828
PFIZER S.A. (BELGIUM)
LU
DE/H/3456/008 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001
RVG 15758 8692806 58.765 5124/2012/01 5124/2012/02 5124/2012/14 5124/2012/05 5124/2012/10 5124/2012/08 5124/2012/13 5124/2012/07 5124/2012/06 5124/2012/09 5124/2012/12 5124/2012/04 5124/2012/03 5124/2012/11 5124/2012/15 5124/2012/19 5124/2012/18 5124/2012/16 5124/2012/17 5124/2012/23
PFIZER B.V. LABORATÓRIOS PFIZER, LDA. VINCIFARMA S.A. PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG
NL PT ES RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO RO
List of nationally authorised medicinal products EMA/716513/2017
Page 18/32
Product Name (in authorisation country)
Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide
MRP/DCP Authorisation number
DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001
List of nationally authorised medicinal products EMA/716513/2017
National Authorisation Number
5124/2012/25 5124/2012/31 5124/2012/21 5124/2012/27 5124/2012/33 5124/2012/29 5124/2012/24 5124/2012/34 5124/2012/20 5124/2012/30 5124/2012/28 5124/2012/22 5124/2012/26 5124/2012/32 027267018 027267448 027267297 027267436 027267412 027267158 027267121 027267273 027267145 027267398 027267386 027267285 027267259 027267400 027267133 027267374 027267261 027267234 027267246 027267347 027267362 027267350
MAH of product in the member state
PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L.
Member State where product is authorised
RO RO RO RO RO RO RO RO RO RO RO RO RO RO IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT
Page 19/32
Product Name (in authorisation country)
Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg capsule rigide Diflucan 50 mg gélules Diflucan 50 mg gélules Diflucan 50 mg hard capsules Diflucan 50 mg hard capsules Diflucan 50 mg hårda kapslar Diflucan 50 mg hårda kapslar Diflucan 50 mg harde capsules Diflucan 50 mg Hartkapseln Fluconazol Diflucan 50 mg Hartkapseln Fluconazol Diflucan 50 mg kapsel, hard Diflucan 50 mg kapsule Diflucan 50 mg kemény kapszula DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001
027267208 027267210 027267222 027267160 027267335 027267172 027267184 027267311 027267309 027267196 027267323 027267424 BE253486 2003097823 PA 19/44/1 PL 00057/0289 10044 11154 BE253486
DE/H/3456/001
BE253486
PFIZER S.A. (BELGIUM)
BE
DE/H/3456/001 DE/H/3456/001 not available
2003097823 7598 UP/I-530-09/11-02/629
PFIZER S.A. (BELGIUM) PFIZER AS PFIZER CROATIA D.O.O.
LU NO HR
DE/H/3456/001
OGYI-T-1550/01
PFIZER KFT.
HU
DE/H/3456/001
LT/1/96/1923/014
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/017
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/018
PFIZER LIMITED
LT
DE/H/3456/001 DE/H/3456/001
LT/1/96/1923/016 LT/1/96/1923/001
PFIZER LIMITED PFIZER LIMITED
LT LT
List of nationally authorised medicinal products EMA/716513/2017
PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER LIMITED PFIZER LIMITED PFIZER OY PFIZER AB PFIZER S.A. (BELGIUM)
IT IT IT IT IT IT IT IT IT IT IT IT BE LU IE UK FI SE BE
Page 20/32
Product Name (in authorisation country)
kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės DIFLUCAN 50 mg kietosios kapsulės Diflucan 50 mg kovat kapselit Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/001
LT/1/96/1923/007
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/012
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/020
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/015
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/019
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/013
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/009
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/008
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/011
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/005
PFIZER LIMITED
LT
DE/H/3456/001
LT/1/96/1923/010
PFIZER LIMITED
LT
DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001
LT/1/96/1923/006 10044 H/93/00473/030 H/93/00473/027 H/93/00473/028 H/93/00473/031 H/93/00473/033 H/93/00473/032 H/93/00473/024 H/93/00473/034 H/93/00473/029 H/93/00473/023 H/93/00473/026
PFIZER LIMITED PFIZER OY PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL
LT FI SI SI SI SI SI SI SI SI SI SI SI
List of nationally authorised medicinal products EMA/716513/2017
Page 21/32
Product Name (in authorisation country)
Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg trde kapsule Diflucan 50 mg tvrdé kapsuly Diflucan 50 mg Tvrdé tobolky Diflucan 50 mg, capsule, hard Diflucan I.V. 2 mg/ml infuzní roztok Diflucan I.V. 2 mg/ml infuzní roztok Diflucan I.V. 2 mg/ml infuzní roztok Diflucan I.V. 2 mg/ml infuzní roztok Diflucan I.V. 2 mg/ml, oplossing voor infusie
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001
H/93/00473/025 H/93/00473/020 H/93/00473/001 H/93/00473/016 H/93/00473/010 H/93/00473/018 H/93/00473/008 H/93/00473/014 H/93/00473/022 H/93/00473/007 H/93/00473/006 H/93/00473/013 H/93/00473/004 H/93/00473/011 H/93/00473/015 H/93/00473/012 H/93/00473/021 H/93/00473/009 H/93/00473/019 H/93/00473/017 H/93/00473/002 H/93/00473/005 H/93/00473/003 26/0121/91–C/S 26/121/91 – A/C RVG 13038
DE/H/3456/006
26/148/91 - C
PFIZER, SPOL. S R.O.
CZ
DE/H/3456/006
26/148/91 - C
PFIZER, SPOL. S R.O.
CZ
DE/H/3456/006
26/148/91 - C
PFIZER, SPOL. S R.O.
CZ
DE/H/3456/006
26/148/91 - C
PFIZER, SPOL. S R.O.
CZ
DE/H/3456/006
RVG 14769
PFIZER B.V.
NL
List of nationally authorised medicinal products EMA/716513/2017
PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER EUROPE MA EEIG PFIZER, SPOL. S R.O. PFIZER B.V.
SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SI SK CZ NL
Page 22/32
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/006
RVG 14769
PFIZER B.V.
NL
DE/H/3456/006
RVG 14769
PFIZER B.V.
NL
DE/H/3456/006
RVG 14769
PFIZER B.V.
NL
DE/H/3456/005
26/0256/96-S
PFIZER EUROPE MA EEIG
SK
DE/H/3456/008
26/0142/12-S
PFIZER EUROPE MA EEIG
SK
DE/H/3456/006
R/0717
PFIZER EUROPE MA EEIG
PL
DE/H/3456/006
R/0717
PFIZER EUROPE MA EEIG
PL
DE/H/3456/006
R/0717
PFIZER EUROPE MA EEIG
PL
DE/H/3456/006
R/0717
PFIZER EUROPE MA EEIG
PL
DE/H/3456/006
13397
PFIZER APS
DK
DE/H/3456/006
13397
PFIZER APS
DK
DE/H/3456/006
13397
PFIZER APS
DK
DE/H/3456/006 DE/H/3456/004 DE/H/3456/001 DE/H/3456/003
13397 13398 13091 13092
PFIZER APS PFIZER APS PFIZER APS PFIZER APS
DK DK DK DK
DE/H/3456/005
14254
DK
Diflucan® 10 mg/ml Trockensaft
DE/H/3456/005
1-19988
Diflucan® 100 mg – Kapseln Diflucan® 100 mg, Hartkapseln Diflucan® 150 mg – Kapseln
DE/H/3456/002 DE/H/3456/002 DE/H/3456/003
1-18836 18943.01.00 1-19976
PFIZER APS PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER PHARMA PFE GMBH PFIZER CORPORATION AUSTRIA
Diflucan I.V. 2 mg/ml, oplossing voor infusie Diflucan I.V. 2 mg/ml, oplossing voor infusie Diflucan I.V. 2 mg/ml, oplossing voor infusie DIFLUCAN P.O.S. 10 mg/ml prášok na perorálnu suspenziu DIFLUCAN P.O.S. 40 mg/ml prášok na perorálnu suspenziu Diflucan, 2 mg/ml, roztwór do infuzji Diflucan, 2 mg/ml, roztwór do infuzji Diflucan, 2 mg/ml, roztwór do infuzji Diflucan, 2 mg/ml, roztwór do infuzji Diflucan, infusionsvæske, opløsning Diflucan, infusionsvæske, opløsning Diflucan, infusionsvæske, opløsning Diflucan, infusionsvæske, opløsning Diflucan, kapsler, hårde Diflucan, kapsler, hårde Diflucan, kapsler, hårde Diflucan, pulver til oral suspension
List of nationally authorised medicinal products EMA/716513/2017
AT AT DE AT Page 23/32
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
DE/H/3456/006
1-18900
DE/H/3456/006
1-18900
DE/H/3456/006
1-18900
DE/H/3456/006
1-18900
Diflucan® 200 mg – Kapseln Diflucan® 200 mg, Hartkapseln Diflucan® 40 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen
DE/H/3456/004 DE/H/3456/004
1-18835 18943.02.00
DE/H/3456/008
89459.00.00
Diflucan® 40 mg/ml Trockensaft
DE/H/3456/008
1-19991
Diflucan® 50 mg – Kapseln Diflucan® 50 mg, Hartkapseln Diflucan® Derm 50 mg, Hartkapseln Diflucan® Derm Saft, 50 mg/10 ml Lösung zum Einnehmen Diflucan® i.v. 2 mg/ml, Infusionslösung Diflucan® i.v. 2 mg/ml, Infusionslösung Diflucan® i.v. 2 mg/ml, Infusionslösung Diflucan® Saft, 50 mg/10 ml Lösung zum Einnehmen Diflucan® Trockensaft 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen
DE/H/3456/001 DE/H/3456/001
ELAZOR 0,5% Gel
Diflucan® 2 mg/ml Infusionslösung Diflucan® 2 mg/ml Infusionslösung Diflucan® 2 mg/ml Infusionslösung Diflucan® 2 mg/ml Infusionslösung
MAH of product in the member state
GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER PHARMA PFE GMBH
Member State where product is authorised
AT AT AT AT AT DE
DE
1-18838 18943.00.00
PFIZER PHARMA PFE GMBH PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER PHARMA PFE GMBH
DE/H/3457/001
28858.00.00
PFIZER PHARMA PFE GMBH
DE
DE/H/3457/002
28858.00.01
PFIZER PHARMA PFE GMBH
DE
DE/H/3456/006
18943.01.02
PFIZER PHARMA PFE GMBH
DE
DE/H/3456/006
18943.01.02
PFIZER PHARMA PFE GMBH
DE
DE/H/3456/006
18943.01.02
PFIZER PHARMA PFE GMBH
DE
DE/H/3456/007
18943.00.01
PFIZER PHARMA PFE GMBH
DE
DE/H/3456/005
18943.00.03
DE
not available
027268061
PFIZER PHARMA PFE GMBH SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
List of nationally authorised medicinal products EMA/716513/2017
AT AT DE
IT
Page 24/32
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
ELAZOR 100 mg capsule rigide ELAZOR 100 mg/ 50 ml Soluzione per infusione
not available
027268046
not available
027268034
ELAZOR 150 mg capsule rigide
not available
027268022
ELAZOR 200 mg capsule rigide
not available
027268097
ELAZOR 50 mg capsule rigide ELAZOR 50 mg/5 ml polvere per sospensione orale Fluconazol "Hexal" Fluconazol ”B. Braun” Fluconazol Accord150 mg Hartkapseln Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg
not available
027268010
not available DK/H/0440/002 DE/H/1055/001
027268059 32818 41844
SE/H/1063/003
84492.00.00
UK/H/1265/002
4238/2012/01
UK/H/1265/002
4238/2012/02
UK/H/1265/002
4238/2012/03
UK/H/1265/002
4238/2012/04
UK/H/1265/002
4238/2012/05
UK/H/1265/002
4238/2012/06
UK/H/1265/002
4238/2012/07
UK/H/1265/002
4238/2012/08
UK/H/1265/002
4238/2012/09
UK/H/1265/002 UK/H/1265/002
4238/2012/10 4238/2012/11
List of nationally authorised medicinal products EMA/716513/2017
MAH of product in the member state
SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. HEXAL A/S B.BRAUN MELSUNGEN AG ACCORD HEALTHCARE LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA)
Member State where product is authorised
IT IT IT IT IT IT DK DK DE RO RO RO RO RO RO RO RO RO RO RO
Page 25/32
Product Name (in authorisation country)
capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 100 mg capsule tari Fluconazol Aurobindo 150 mg Hartkapseln Fluconazol B. Braun 2 mg/ml Infusionslösung Fluconazol B. Braun 2 mg/ml Infusionslösung Fluconazol B. Braun 2 mg/ml Infusionslösung Fluconazol B. Braun 2 mg/ml infusjonsvæske, oppløsning Fluconazol B. Braun 2 mg/ml solución para perfusión EFG Fluconazol B. Braun 2 mg/ml, oplossing voor infusie Fluconazol B. Braun, 2 mg/ml, solução para perfusão Fluconazol B. Braun, 2 mg/ml, solução para perfusão Fluconazol B. Braun, 2 mg/ml, solução para perfusão
MRP/DCP Authorisation number
National Authorisation Number
UK/H/1265/002
4238/2012/12
UK/H/1265/002
4238/2012/13
UK/H/1265/002
4238/2012/14
UK/H/1265/002
4238/2012/15
UK/H/1265/002
4238/2012/16
UK/H/1265/002
4238/2012/17
UK/H/1265/002
4238/2012/18
UK/H/1265/002
4238/2012/19
LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED
UK/H/1265/003
72224.00.00
AUROBINDO PHARMA GMBH
DE
DE/H/1055/001
1-28430
B. BRAUN MELSUNGEN AG ART 57
AT
DE/H/1055/001
69716.00.00
B.BRAUN MELSUNGEN AG
DE
DE/H/1055/001
0667/08120050
B.BRAUN MELSUNGEN AG
LU
DE/H/1055/001
07-5146
B.BRAUN MELSUNGEN AG
NO
DE/H/1055/001
71461
B.BRAUN MELSUNGEN AG
ES
DE/H/1055/001
RVG 100710
B.BRAUN MELSUNGEN AG
NL
DE/H/1055/001
5178314
B.BRAUN MELSUNGEN AG
PT
DE/H/1055/001
5178330
B.BRAUN MELSUNGEN AG
PT
DE/H/1055/001
5178322
B.BRAUN MELSUNGEN AG
PT
List of nationally authorised medicinal products EMA/716513/2017
MAH of product in the member state
Member State where product is authorised
RO RO RO RO RO RO RO RO
Page 26/32
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/1055/001
5178355
B.BRAUN MELSUNGEN AG
PT
DE/H/1055/001
5178348
B.BRAUN MELSUNGEN AG
PT
DE/H/1055/001
5178363
B.BRAUN MELSUNGEN AG
PT
DE/H/1055/001
5178405
B.BRAUN MELSUNGEN AG
PT
DE/H/1055/001
5178371
B.BRAUN MELSUNGEN AG
PT
DE/H/1055/001
5178306
B.BRAUN MELSUNGEN AG
PT
not available
3659/2011/01
LABORMED PHARMA S.A.
RO
not available
3658/2011/01
LABORMED PHARMA S.A.
RO
DE/H/3457/005
89509.00.00
PFIZER PHARMA PFE GMBH
DE
DE/H/3457/006
90450.00.00
PFIZER PHARMA PFE GMBH
DE
DE/H/3457/003
89510.00.00
PFIZER PHARMA PFE GMBH
DE
DE/H/3457/004
89511.00.00
DE
Fluconazole 100 mg Capsules Fluconazole 100 mg capsules, hard Fluconazole 100 mg καψάκια, σκληρά
not available
PL 36722/0121
PFIZER PHARMA PFE GMBH SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK/H/1265/002
PL 16363/0316
UK
UK/H/1265/002
79974
Fluconazole 150 mg Capsules Fluconazole 150mg Capsules Fluconazole 150mg Capsules Fluconazole 150mg Capsules Fluconazole 2 mg/ml solution
not available not available not available not available DE/H/1055/001
PL 36722/0122 PL 21880/0135 PL 20395/0042 PL 20395/0041 PA 736/30/1
MILPHARM LIMITED AUROBINDO PHARMA (MALTA) LIMITED SPECIAL CONCEPT DEVELOPMENT (UK) LTD MEDREICH PLC RELON CHEM LIMITED RELON CHEM LIMITED B.BRAUN MELSUNGEN AG
Fluconazol B. Braun, 2 mg/ml, solução para perfusão Fluconazol B. Braun, 2 mg/ml, solução para perfusão Fluconazol B. Braun, 2 mg/ml, solução para perfusão Fluconazol B. Braun, 2 mg/ml, solução para perfusão Fluconazol B. Braun, 2 mg/ml, solução para perfusão Fluconazol B. Braun, 2 mg/ml, solução para perfusão FLUCONAZOL LPH 150 mg capsule FLUCONAZOL LPH 50 mg capsule Fluconazol Pfizer 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen Fluconazol Pfizer 150 mg Hartkapseln Fluconazol Pfizer® 100 mg Hartkapseln Fluconazol Pfizer® 200 mg Hartkapseln
List of nationally authorised medicinal products EMA/716513/2017
UK
GR UK UK UK UK IE
Page 27/32
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/1055/001
PL 03551/0115
UK
Fluconazole 200 mg Capsules Fluconazole 200mg Capsules
not available not available
PL 36722/0123 PL 21880/0136
Fluconazole 50 mg Capsules Fluconazole 50mg Capsules Fluconazole B. Braun 2 mg/ml infusionsvätska, lösning Fluconazole B. Braun 2 mg/ml infuusioneste, liuos Fluconazole B. Braun 2 mg/ml infuzní roztok Fluconazole B. Braun 2 mg/ml infúzny roztok Fluconazole B. Braun 2 mg/ml oldatos infúzió Fluconazole B. Braun 2 mg/ml oldatos infúzió Fluconazole B. Braun 2 mg/ml oldatos infúzió Fluconazole B. Braun 2 mg/ml oldatos infúzió Fluconazole B. Braun 2 mg/ml oldatos infúzió Fluconazole B. Braun 2 mg/ml oldatos infúzió Fluconazole B. Braun 2 mg/ml oldatos infúzió Fluconazole B. Braun 2 mg/ml oldatos infúzió Fluconazole B. Braun 2 mg/ml oldatos infúzió Fluconazole B. Braun 2 mg/ml solution pour perfusion
not available not available
PL 36722/0120 PL 21880/0134
B.BRAUN MELSUNGEN AG SPECIAL CONCEPT DEVELOPMENT (UK) LTD MEDREICH PLC SPECIAL CONCEPT DEVELOPMENT (UK) LTD MEDREICH PLC
DE/H/1055/001
25835
B.BRAUN MELSUNGEN AG
SE
DE/H/1055/001
23931
B.BRAUN MELSUNGEN AG
FI
DE/H/1055/001
26/048/09-C
B.BRAUN MELSUNGEN AG
CZ
DE/H/1055/001
26/0074/09-S
B.BRAUN MELSUNGEN AG
SK
DE/H/1055/001
OGYI-T-21734/04
B.BRAUN MELSUNGEN AG
HU
DE/H/1055/001
OGYI-T-21734/05
B.BRAUN MELSUNGEN AG
HU
DE/H/1055/001
OGYI-T-21734/06
B.BRAUN MELSUNGEN AG
HU
DE/H/1055/001
OGYI-T-21734/07
B.BRAUN MELSUNGEN AG
HU
DE/H/1055/001
OGYI-T-21734/08
B.BRAUN MELSUNGEN AG
HU
DE/H/1055/001
OGYI-T-21734/09
B.BRAUN MELSUNGEN AG
HU
DE/H/1055/001
OGYI-T-21734/01
B.BRAUN MELSUNGEN AG
HU
DE/H/1055/001
OGYI-T-21734/02
B.BRAUN MELSUNGEN AG
HU
DE/H/1055/001
OGYI-T-21734/03
B.BRAUN MELSUNGEN AG
HU
DE/H/1055/001
BE334014
B.BRAUN MELSUNGEN AG
BE
for infusion Fluconazole 2 mg/ml solution for infusion
List of nationally authorised medicinal products EMA/716513/2017
UK UK UK UK
Page 28/32
Product Name (in authorisation country)
Fluconazole B. Braun 2 mg/ml solution pour perfusion Fluconazole B. Braun 2 mg/ml solution pour perfusion Fluconazole B. Braun 2 mg/ml διάλυμα προς έγχυση Fluconazole B. Braun 2 mg/ml, oplossing voor infusie Fluconazole B. Braun 2 mg/ml, oplossing voor infusie Fluconazole B. Braun 2 mg/ml, oplossing voor infusie Fluconazole B. Braun 2 mg/ml, roztwór do infuzji FLUCONAZOLE PFIZER 100 mg, gélule FLUCONAZOLE PFIZER 100 mg, gélule FLUCONAZOLE PFIZER 150 mg, gélule FLUCONAZOLE PFIZER 200 mg, gélule FLUCONAZOLE PFIZER 200 mg, gélule FLUCONAZOLE PFIZER 50 mg, gélule FLUCONAZOLE PFIZER 50 mg, gélule FLUCONAZOLE PFIZER 50 mg, gélule FLUCONAZOLE PFIZER 50 mg/5 ml, poudre pour suspension buvable FLUCONAZOLE PFIZER 50 mg/5 ml, poudre pour suspension buvable Fluconazolo B. Braun 2 mg/ml
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/1055/001
BE334065
B.BRAUN MELSUNGEN AG
BE
DE/H/1055/001
BE334083
B.BRAUN MELSUNGEN AG
BE
DE/H/1055/001
64925/14-09-2009
B.BRAUN MELSUNGEN AG
GR
DE/H/1055/001
BE334014
B.BRAUN MELSUNGEN AG
BE
DE/H/1055/001
BE334065
B.BRAUN MELSUNGEN AG
BE
DE/H/1055/001
BE334083
B.BRAUN MELSUNGEN AG
BE
DE/H/1055/001
15636
B.BRAUN MELSUNGEN AG
PL
DE/H/3457/003
34009 346 591 7 1
PFIZER HOLDING FRANCE
FR
DE/H/3457/003
34009 338 672 1 8
PFIZER HOLDING FRANCE
FR
DE/H/3456/003
34009 330 553 3 2
PFIZER HOLDING FRANCE
FR
DE/H/3457/004
34009 346 590 0 3
PFIZER HOLDING FRANCE
FR
DE/H/3457/004
34009 338 677 3 7
PFIZER HOLDING FRANCE
FR
DE/H/3457/001
34009 338 679 6 6
PFIZER HOLDING FRANCE
FR
DE/H/3457/001
34009 558 948 6 5
PFIZER HOLDING FRANCE
FR
DE/H/3457/001
34009 338 680 4 8
PFIZER HOLDING FRANCE
FR
DE/H/3457/005
34009 338 682 7 7
PFIZER HOLDING FRANCE
FR
DE/H/3457/005 DE/H/1055/001
34009 338 682 7 7 038838025
PFIZER HOLDING FRANCE B.BRAUN MELSUNGEN AG
FR IT
List of nationally authorised medicinal products EMA/716513/2017
Page 29/32
Product Name (in authorisation country)
soluzione per infusione Fluconazolo B. Braun 2 mg/ml soluzione per infusione Fluconazolo B. Braun 2 mg/ml soluzione per infusione Fluconazolo B. Braun 2 mg/ml soluzione per infusione Fluconazolo B. Braun 2 mg/ml soluzione per infusione Fluconazolo B. Braun 2 mg/ml soluzione per infusione Fluconazolo B. Braun 2 mg/ml soluzione per infusione Fluconazolo B. Braun 2 mg/ml soluzione per infusione Fluconazolo B. Braun 2 mg/ml soluzione per infusione Flukonazol B. Braun 2 mg/ml raztopina za infundiranje Flukonazol B. Braun 2 mg/ml raztopina za infundiranje Flukonazol B. Braun 2 mg/ml raztopina za infundiranje Fungata® Fungata® 150 mg – Kapsel Fungustatin 10 mg/ml κόνις για πόσιμο εναιώρημα Fungustatin 100 mg σκληρά καψάκια Fungustatin 150 mg σκληρά καψάκια Fungustatin 150 mg σκληρά καψάκια Fungustatin 2 mg/ml διάλυμα για έγχυση Fungustatin 2 mg/ml διάλυμα
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/1055/001
038838037
B.BRAUN MELSUNGEN AG
IT
DE/H/1055/001
038838049
B.BRAUN MELSUNGEN AG
IT
DE/H/1055/001
038838052
B.BRAUN MELSUNGEN AG
IT
DE/H/1055/001
038838064
B.BRAUN MELSUNGEN AG
IT
DE/H/1055/001
038838076
B.BRAUN MELSUNGEN AG
IT
DE/H/1055/001
038838088
B.BRAUN MELSUNGEN AG
IT
DE/H/1055/001
038838090
B.BRAUN MELSUNGEN AG
IT
DE/H/1055/001
038838013
B.BRAUN MELSUNGEN AG
IT
DE/H/1055/001
H/09/00634/003
B.BRAUN MELSUNGEN AG
SI
DE/H/1055/001
H/09/00634/002
B.BRAUN MELSUNGEN AG
SI
DE/H/1055/001 DE/H/3456/003
H/09/00634/001 15824.00.00
SI DE
DE/H/3457/006
1-18837
B.BRAUN MELSUNGEN AG PFIZER PHARMA PFE GMBH PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
DE/H/3456/005
41148/10/31-05-2011
PFIZER HELLAS, A.E.
GR
DE/H/3456/002
41145/10/31-05-2011
PFIZER HELLAS, A.E.
GR
DE/H/3456/003
13273
PFIZER HELLAS, A.E.
CY
DE/H/3456/003
41146/10/31-05-2011
PFIZER HELLAS, A.E.
GR
DE/H/3456/006 DE/H/3456/006
13275 13275
PFIZER HELLAS, A.E. PFIZER HELLAS, A.E.
CY CY
List of nationally authorised medicinal products EMA/716513/2017
AT
Page 30/32
Product Name (in authorisation country)
για έγχυση Fungustatin 2 mg/ml διάλυμα για έγχυση Fungustatin 2 mg/ml διάλυμα για έγχυση Fungustatin 2 mg/ml διάλυμα για έγχυση Fungustatin 2 mg/ml διάλυμα για έγχυση Fungustatin 2 mg/ml διάλυμα για έγχυση Fungustatin 2 mg/ml διάλυμα για έγχυση Fungustatin 200 mg σκληρά καψάκια Fungustatin 40 mg/ml κόνις για πόσιμο εναιώρημα Fungustatin 50 mg σκληρά καψάκια LAVISA 150 mg cápsulas duras MYCAZOLE MYCAZOLE MYCAZOLE 200 mg κόνις για πόσιμο διάλυμα TRIFLUCAN 100 mg, gélule TRIFLUCAN 100 mg, gélule TRIFLUCAN 2 mg/ml, solution pour perfusion TRIFLUCAN 2 mg/ml, solution pour perfusion TRIFLUCAN 2 mg/ml, solution pour perfusion TRIFLUCAN 2 mg/ml, solution pour perfusion TRIFLUCAN 2 mg/ml, solution pour perfusion TRIFLUCAN 2 mg/ml, solution
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/006
13275
PFIZER HELLAS, A.E.
CY
DE/H/3456/006
13275
PFIZER HELLAS, A.E.
CY
DE/H/3456/006
71799/30-9-2016
PFIZER HELLAS, A.E.
GR
DE/H/3456/006
71799/30-9-2016
PFIZER HELLAS, A.E.
GR
DE/H/3456/006
71799/30-9-2016
PFIZER HELLAS, A.E.
GR
DE/H/3456/006
71799/30-9-2016
PFIZER HELLAS, A.E.
GR
DE/H/3456/004
41147/10/31-05-2011
PFIZER HELLAS, A.E.
GR
DE/H/3456/008
41150/10/31-05-2011
PFIZER HELLAS, A.E.
GR
DE/H/3456/001 not available not available not available
41144/10/31-05-2011 59.059 27544/14 27545/14
PFIZER HELLAS, A.E. GYNEA LABORATORIOS, S.L. VERISFIELD (UK) LTD VERISFIELD (UK) LTD
GR ES GR GR
not available DE/H/3456/002 DE/H/3456/002
27546/14 34009 345 574 1 5 34009 332 659 3 9
VERISFIELD (UK) LTD PFIZER HOLDING FRANCE PFIZER HOLDING FRANCE
GR FR FR
DE/H/3456/006
34009 374 129 2 6
PFIZER HOLDING FRANCE
FR
DE/H/3456/006
34009 332 662 4 0
PFIZER HOLDING FRANCE
FR
DE/H/3456/006
34009 332 661 8 9
PFIZER HOLDING FRANCE
FR
DE/H/3456/006
34009 374 130 0 8
PFIZER HOLDING FRANCE
FR
DE/H/3456/006 DE/H/3456/006
34009 332 663 0 1 34009 332 660 1 1
PFIZER HOLDING FRANCE PFIZER HOLDING FRANCE
FR FR
List of nationally authorised medicinal products EMA/716513/2017
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Product Name (in authorisation country)
pour perfusion TRIFLUCAN 200 mg, gélule TRIFLUCAN 200 mg, gélule TRIFLUCAN 200 mg/ 5 ml, poudre pour suspension buvable TRIFLUCAN 50 mg, gélule TRIFLUCAN 50 mg, gélule TRIFLUCAN 50 mg, gélule TRIFLUCAN 50 mg/5 ml, poudre pour suspension buvable TRIFLUCAN 50 mg/5 ml, poudre pour suspension buvable Дифлукан 150 mg капсули, твърди Дифлукан 2 mg/ml инфузионен разтвор Дифлукан 2 mg/ml инфузионен разтвор Дифлукан 2 mg/ml инфузионен разтвор Дифлукан 2 mg/ml инфузионен разтвор
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/3456/004 DE/H/3456/004
34009 345 575 8 3 34009 332 658 7 8
PFIZER HOLDING FRANCE PFIZER HOLDING FRANCE
FR FR
DE/H/3456/008 DE/H/3456/001 DE/H/3456/001 DE/H/3456/001
34009 335 471 5 8 34009 556 136 4 0 34009 330 552 7 1 34009 330 551 0 3
PFIZER HOLDING FRANCE PFIZER HOLDING FRANCE PFIZER HOLDING FRANCE PFIZER HOLDING FRANCE
FR FR FR FR
DE/H/3456/005
34009 335 470 9 7
PFIZER HOLDING FRANCE
FR
DE/H/3456/005
34009 335 470 9 7
PFIZER HOLDING FRANCE
FR
DE/H/3456/003
20010472
PFIZER EUROPE MA EEIG
BG
DE/H/3456/006
20010470
PFIZER EUROPE MA EEIG
BG
DE/H/3456/006
20010470
PFIZER EUROPE MA EEIG
BG
DE/H/3456/006
20010470
PFIZER EUROPE MA EEIG
BG
DE/H/3456/006
20010470
PFIZER EUROPE MA EEIG
BG
List of nationally authorised medicinal products EMA/716513/2017
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