29 September 2017 EMA/641530/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: omega-3-acid-ethyl esters
Procedure no.: PSUSA/00010312/201701
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)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Dualtis 1000 mg
FR/H/0261/001
PL 15905/0002
PRONOVA BIOPHARMA
UK
capsules, soft Dualtis 1000 mg meke
NORGE AS not available
UP/I-530-09/12-01/152
MYLAN HRVATSKA D.O.O.
HR
not available
027617024
PFIZER ITALIA S.R.L.
IT
not available
027617012
PFIZER ITALIA S.R.L.
IT
not available
027618040
SIGMA-TAU INDUSTRIE
IT
kapsule ESAPENT 1000 mg Capsule molli ESAPENT 500 mg Capsule molli ESKIM 1000 mg capsule molli
FARMACEUTICHE RIUNITE S.P.A.
ESKIM 1000 mg capsule
not available
027618053
molli
SIGMA-TAU INDUSTRIE
IT
FARMACEUTICHE RIUNITE S.P.A.
ESKIM 500 mg capsule
not available
027618038
molli
SIGMA-TAU INDUSTRIE
IT
FARMACEUTICHE RIUNITE S.P.A.
Omacor 1000 mg
FR/H/0105/001
65.476
cápsulas blandas Omacor 1000 mg
ES
NORGE AS FR/H/0105/001
BE253066
capsules molles Omacor 1000 mg
PRONOVA BIOPHARMA
PRONOVA BIOPHARMA
BE
NORGE AS FR/H/105/01
capsules molles
List of nationally authorised medicinal products EMA/639207/2017
2011071232
PRONOVA BIOPHARMA
LU
NORGE AS
Page 2/10
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
Omacor 1000 mg lágy
FR/H/105/01
OGYI-T-9691/01
PRONOVA BIOPHARMA
HU
kapzula Omacor 1000 mg lágy
NORGE AS FR/H/105/01
OGYI-T-9691/02
kapzula Omacor 1000 mg lágy
FR/H/105/01
OGYI-T-9691/03
FR/H/0105/001
31/0378/05-S
FR/H/105/01
H/05/01172/001
FR/H/0105/001
H/05/01172/002
FR/H/0105/001
H/05/01172/003
PRONOVA BIOPHARMA
SI
PRONOVA BIOPHARMA
SI
PRONOVA BIOPHARMA
SI
NORGE AS FR/H/0105/001
H/05/01172/004
kapsule Omacor 1000 mg mehke
SK
NORGE AS
kapsule Omacor 1000 mg mehke
PRONOVA BIOPHARMA
NORGE AS
kapsule Omacor 1000 mg mehke
HU
NORGE AS
kapsule Omacor 1000 mg mehke
PRONOVA BIOPHARMA NORGE AS
kapsuly Omacor 1000 mg mehke
HU
NORGE AS
kapzula Omacor 1000 mg mäkké
PRONOVA BIOPHARMA
PRONOVA BIOPHARMA
SI
NORGE AS FR/H/0105/001
kapsule
List of nationally authorised medicinal products EMA/639207/2017
H/05/01172/005
PRONOVA BIOPHARMA
SI
NORGE AS
Page 3/10
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
Omacor 1000 mg mehke
FR/H/0105/001
H/05/01172/006
PRONOVA BIOPHARMA
SI
kapsule Omacor 1000 mg meke
NORGE AS not available
HR-H-239310133
MYLAN HRVATSKA D.O.O.
HR
FR/H/0105/001
05-0465
PRONOVA BIOPHARMA
LV
kapsule Omacor 1000 mg mīkstās kapsulas Omacor 1000 mg
NORGE AS FR/H/0105/001
LT/1/05/0319/003
minkštosios kapsules Omacor 1000 mg
FR/H/0105/001
LT/1/05/0319/001
FR/H/0105/001
LT/1/05/0319/004
FR/H/0105/001
LT/1/05/0319/002
PRONOVA BIOPHARMA
LT
PRONOVA BIOPHARMA
LT
NORGE AS FR/H/0105/001
LT/1/05/0319/005
minkštosios kapsules Omacor 1000 mg Soft
LT
NORGE AS
minkštosios kapsules Omacor 1000 mg
PRONOVA BIOPHARMA NORGE AS
minkštosios kapsules Omacor 1000 mg
LT
NORGE AS
minkštosios kapsules Omacor 1000 mg
PRONOVA BIOPHARMA
PRONOVA BIOPHARMA
LT
NORGE AS FR/H/0105/001
Capsules
List of nationally authorised medicinal products EMA/639207/2017
1099/1/1
PRONOVA BIOPHARMA
IE
NORGE AS
Page 4/10
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
Omacor 1000 mg
FR/H/0105/001
1-21530
PRONOVA BIOPHARMA
AT
Weichkapseln Omacor 1000 mg
NORGE AS FR/H/0105/001
BE253066
Weichkapseln Omacor 1000 mg
FR/H/0105/001
2011071232
FR/H/0105/001
BE253066
FR/H/0105/001
5336888
FR/H/0105/001
4452884
FR/H/0105/001
5336987
PRONOVA BIOPHARMA
PT
PRONOVA BIOPHARMA
PT
PRONOVA BIOPHARMA
PT
NORGE AS FR/H/0105/001
4452983
cápsulas moles Omacor 1000 mg,
BE
NORGE AS
cápsulas moles Omacor 1000 mg,
PRONOVA BIOPHARMA
NORGE AS
cápsulas moles Omacor 1000 mg,
LU
NORGE AS
cápsulas moles Omacor 1000 mg,
PRONOVA BIOPHARMA NORGE AS
capsules Omacor 1000 mg,
BE
NORGE AS
Weichkapseln OMACOR 1000 mg zachte
PRONOVA BIOPHARMA
PRONOVA BIOPHARMA
PT
NORGE AS FR/H/0105/001
cápsulas moles
List of nationally authorised medicinal products EMA/639207/2017
4453080
PRONOVA BIOPHARMA
PT
NORGE AS
Page 5/10
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
OMACOR 1000 mg,
FR/H/0105/001
34009 339 435 3 0
PRONOVA BIOPHARMA
FR
capsule molle OMACOR 1000 mg,
NORGE AS FR/H/0105/001
34009 563 901 4 4
capsule molle OMACOR 1000 mg,
FR/H/105/001
34009 300 105 3 2
FR/H/105/001
34009 300 105 4 9
FR/H/105/001
34009 300 198 1 8
FR/H/0105/001
34009 357 025 8 6
FR/H/0105/001
517/00101
PRONOVA BIOPHARMA
FR
PRONOVA BIOPHARMA
FR
PRONOVA BIOPHARMA
MT
NORGE AS FR/H/0105/001
PL 15905/0001
capsules, soft Omacor kapsel, myk
FR
NORGE AS
capsules, soft Omacor 1000 mg,
PRONOVA BIOPHARMA
NORGE AS
capsule molle Omacor 1000 mg,
FR
NORGE AS
capsule molle Omacor 1000 mg,
PRONOVA BIOPHARMA NORGE AS
capsule molle OMACOR 1000 mg,
FR
NORGE AS
capsule molle OMACOR 1000 mg,
PRONOVA BIOPHARMA
PRONOVA BIOPHARMA
UK
NORGE AS not available
8041
PRONOVA BIOPHARMA
NO
NORGE AS
List of nationally authorised medicinal products EMA/639207/2017
Page 6/10
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
Omacor, 1000 mg
FR/H/0105/001
430203
PRONOVA BIOPHARMA
EE
pehmekapslid Omacor, 1000 mg,
NORGE AS not available
4325/2004/01
capsule moi OMACOR, 1000 mg,
not available
4325/2004/03
not available
4325/2004/04
not available
4325/2004/02
FR/H/0105/001
12303
FR/H/0105/001
31/366/05-C
PRONOVA BIOPHARMA
RO
PRONOVA BIOPHARMA
PL
PRONOVA BIOPHARMA
CZ
NORGE AS FR/H/0105/001
RVG 28822
460 mg/380 mg Omacor® 1000 mg
RO
NORGE AS
měkké tobolky Omacor, zachte capsules,
PRONOVA BIOPHARMA
NORGE AS
kapsułki miękkie Omacor, 1000 mg,
RO
NORGE AS
capsule moi, Omacor, 1000 mg,
PRONOVA BIOPHARMA NORGE AS
capsule moi Omacor, 1000 mg,
RO
NORGE AS
capsule moi OMACOR, 1000 mg,
PRONOVA BIOPHARMA
PRONOVA BIOPHARMA
NL
NORGE AS FR/H/0105/001
Weichkapseln
List of nationally authorised medicinal products EMA/639207/2017
37312.00.00
PRONOVA BIOPHARMA
DE
NORGE AS
Page 7/10
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
OMACOR® 1000 mg,
FR/H/0105/001
20055
PRONOVA BIOPHARMA
CY
καψάκια, μαλακά OMACOR® καψάκιο,
NORGE AS FR/H/0105/001
3196/13-1-2009
μαλακό SEACOR 1000 mg
not available
027616034
SPA – SOCIETÀ PRODOTTI
IT
ANTIBIOTICI S.P.A. not available
027616022
Capsule molli SEACOR 500 mg Capsule
GR
(GREECE)
Capsule molli SEACOR 1000 mg
BGP PRODUCTS LTD
SPA – SOCIETÀ PRODOTTI
IT
ANTIBIOTICI S.P.A. not available
027616010
molli
SPA – SOCIETÀ PRODOTTI
IT
ANTIBIOTICI S.P.A.
Zidoril cápsula mole
not available
5550371
FERRER PORTUGAL, S.A.
PT
Zidoril cápsula mole
not available
5550405
FERRER PORTUGAL, S.A.
PT
Zodin 1000 mg -
FR/H/261/01
1-26485
PRONOVA BIOPHARMA
AT
Weichkapseln Zodin 1000 mg καψάκια,
NORGE AS FR/H/0261/001
77126/30-10-2015
FERRER-GALENICA S.A.
GR
μαλακά
List of nationally authorised medicinal products EMA/639207/2017
Page 8/10
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
ZODIN 1000 mg, capsule
FR/H/0261/001
34009 374 834 8 3
PRONOVA BIOPHARMA
FR
molle ZODIN 1000 mg, capsule
NORGE AS FR/H/0261/001
34009 361 971 1 4
molle ZODIN 1000 mg, capsule
FR/H/0261/001
34009 374 835 4 4
FR/H/0261/001
34009 564 880 0 1
FR/H/0261/001
34009 564 881 7 9
FR/H/261/01
5015839
FR/H/261/01
5409784
PRONOVA BIOPHARMA
FR
PRONOVA BIOPHARMA
PT
PRONOVA BIOPHARMA
PT
NORGE AS FR/H/261/01
5015847
mole ZODIN, 1000 mg cápsula
FR
NORGE AS
mole ZODIN, 1000 mg cápsula
PRONOVA BIOPHARMA
NORGE AS
mole ZODIN, 1000 mg cápsula
FR
NORGE AS
molle ZODIN, 1000 mg cápsula
PRONOVA BIOPHARMA NORGE AS
molle ZODIN 1000 mg, capsule
FR
NORGE AS
molle ZODIN 1000 mg, capsule
PRONOVA BIOPHARMA
PRONOVA BIOPHARMA
PT
NORGE AS FR/H/261/01
mole
List of nationally authorised medicinal products EMA/639207/2017
5409883
PRONOVA BIOPHARMA
PT
NORGE AS
Page 9/10
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
Zodin, 1000 mg cápsula
FR/H/261/01
5409982
PRONOVA BIOPHARMA
PT
mole Zodin® Omega-3 1000
NORGE AS FR/H/0261/001
60885.00.00
mg Weichkapseln Омакор 1000 mg меки
PRONOVA BIOPHARMA
DE
NORGE AS not available
капсули
List of nationally authorised medicinal products EMA/639207/2017
20040231
PRONOVA BIOPHARMA
BG
NORGE AS
Page 10/10
