30 November 2017 EMA/795271/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: vinorelbine
Procedure no.: PSUSA/00003124/201704
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation
MRP/DCP Authorisation
National
MAH of product in the
Member State where
country)
number
Authorisation Number
member state
product is authorised
Navelbine 50 mg/5 ml solution à
not available
BE177581
SAS PIERRE FABRE
BE
diluer pour perfusion Navelbine, koncentrat til
MEDICAMENT not available
16662
not available
41571/23-9-2008
not available
OGYI-T-4721/01
infusionsvæske, opløsning Navelbine 10 mg/ml, ενέσιμο
not available
027865082
SAS PIERRE FABRE
HU
PIERRE FABRE PHARMA
IT
S.R.L. not available
99-0347
infūziju šķīduma pagatavošanai Navelbine 10 mg/ml koncentrat till
GR
MEDICAMENT
per soluzione per infusione NAVELBINE 10 mg/ml koncentrāts
PIERRE FABRE FARMAKA SA
oldatos infúzióhoz NAVELBINE 10 mg/ml concentrato
DK
NORDEN AB
διάλυμα Navelbine 10 mg/ml koncentrátum
PIERRE FABRE PHARMA
PIERRE FABRE
LV
MEDICAMENT not available
12784
NAVELBINE 20 mg capsules molles
not available
BE276735
Navelbine, bløde kapsler
not available
33326
infusionsvätska, lösning
PIERRE FABRE PHARMA
SE
NORDEN AB/SW PIERRE FABRE
BE
MEDICAMENT PIERRE FABRE PHARMA
DK
NORDEN AB NAVELBINE 20 mg μαλακό καψάκιο
not available
41579
PIERRE FABRE FARMAKA /
GR
GREECE NAVELBINE 20 mg capsule molli
not available
027865106
PIERRE FABRE PHARMA
IT
S.R.L. NAVELBINE 20 mg, capsule molle
not available
0724/01/12/0034
PIERRE FABRE
LU
Navelbine, kapsułka miękka, 20 mg
not available
9450
SAS PIERRE FABRE
NAVELBINE 20 mg, cápsula mole
not available
3528288
PFM / PORTUGAL
PT
NAVELBINE 20 mg capsule moi
not available
6075/2005/01
PIERRE FABRE
RO
MEDICAMENT PL
MEDICAMENT
MEDICAMENT List of nationally authorised medicinal products EMA/795271/2017
Page 2/9
Product Name (in authorisation
MRP/DCP Authorisation
National
MAH of product in the
Member State where
country)
number
Authorisation Number
member state
product is authorised
Navelbine 20 mg mjuk kapsel
not available
16379
PIERRE FABRE PHARMA
SE
NORDEN AB/SW NAVELBINE 30 mg capsules molles
not available
BE276744
Navelbine, bløde kapsler
not available
33327
NAVELBINE 30 mg μαλακό καψάκιο
not available
41580/23-9-2008
PIERRE FABRE
BE
MEDICAMENT PIERRE FABRE PHARMA
DK
NORDEN AB PIERRE FABRE FARMAKA /
GR
GREECE NAVELBINE 30 mg capsule molli
not available
027865118
PFM PHARMA / ITALY
IT
NAVELBINE 30 mg, capsule molle
not available
0724/01/12/0035
PIERRE FABRE
LU
MEDICAMENT Navelbine, kapsułka miękka, 30 mg
not available
9451
SAS PIERRE FABRE
PL
MEDICAMENT NAVELBINE 30 mg, cápsula mole
not available
3528387
PFM / PORTUGAL
PT
NAVELBINE 30 mg capsule moi
not available
6076/2005/01
SAS PIERRE FABRE
RO
MEDICAMENT Navelbine 30 mg mjuk kapsel
not available
16380
PIERRE FABRE PHARMA
SE
NORDEN AB/SW Navelbine, bløde kapsler
not available
33329
PIERRE FABRE PHARMA
DK
NORDEN AB Navelbine 80 mg mjuk kapsel
not available
16382
PIERRE FABRE PHARMA
SE
NORDEN AB/SW Navelbine20 mg kapsel, myk
not available
02/1154
Navelbine80 mg kapsel, myk
not available
02/1157
PIERRE FABRE PHARMA
NO
NORDEN AB PIERRE FABRE PHARMA
NO
NORDEN AB Navelbine30 mg kapsel, myk
not available
02/1155
PIERRE FABRE PHARMA
NO
NORDEN AB
List of nationally authorised medicinal products EMA/795271/2017
Page 3/9
Product Name (in authorisation
MRP/DCP Authorisation
National
MAH of product in the
Member State where
country)
number
Authorisation Number
member state
product is authorised
Navelbine 10 mg/ml, konsentrat til
not available
95-2385
PIERRE FABRE PHARMA
NO
infusjonsvæske Navelbine 50 mg/5 ml concentraat
NORDEN AB not available
BE177581
voor oplossing voor intraveneuze
SAS PIERRE FABRE
BE
MEDICAMENT
infusie NAVELBINE 30 mg capsules, zacht
not available
BE276744
PIERRE FABRE
BE
MEDICAMENT NAVELBINE 20 mg capsules, zacht
not available
BE276735
PIERRE FABRE
Navelbine 10 mg/ml koncentrátum
not available
OGYI-T-4721/02
SAS PIERRE FABRE
not available
0724/04048619
PIERRE FABRE
BE
MEDICAMENT oldatos infúzióhoz NAVELBINE 50 mg/5 ml, solution
MEDICAMENT
injectable en flacon NAVELBINE 30 mg capsule moi
HU LU
MEDICAMENT not available
6076/2005/02
PIERRE FABRE
RO
MEDICAMENT NAVELBINE 10 mg/ml concentrato
not available
027865094
PFM PHARMA / ITALY
IT
not available
6075/2005/02
PIERRE FABRE
RO
per soluzione per infusione NAVELBINE 20 mg capsule moi
MEDICAMENT Navelbine 40 mg/4 ml solution à
not available
BE177597
not available
BE177606
diluer pour perfusion Navelbine 10 mg/1 ml solution à
BE
MEDICAMENT
diluer pour perfusion Navelbine 40 mg/4 ml concentraat
SAS PIERRE FABRE SAS PIERRE FABRE
BE
MEDICAMENT not available
BE177597
voor oplossing voor intraveneuze
SAS PIERRE FABRE
BE
MEDICAMENT
infusie Navelbine 10 mg/1 ml concentraat voor oplossing voor intraveneuze
not available
BE177606
SAS PIERRE FABRE
BE
MEDICAMENT
infusie List of nationally authorised medicinal products EMA/795271/2017
Page 4/9
Product Name (in authorisation
MRP/DCP Authorisation
National
MAH of product in the
Member State where
country)
number
Authorisation Number
member state
product is authorised
Navelbine 10 mg/ml, ενέσιμο
not available
41576/23-9-2008
PIERRE FABRE FARMAKA
GR
διάλυμα Navelbine 10 mg/ml, ενέσιμο
SA not available
41578/23-9-2008
PIERRE FABRE FARMAKA
not available
4661/2012/02
SAS PIERRE FABRE
not available
4661/2012/03
διάλυμα Navelbine 10 mg/ml concentrat
SA
pentru soluţie perfuzabilă Navelbine 10 mg/ml concentrat
not available
0724/04048618
not available
20020969
not available
R/1736
not available
4661/2012/01
LU
PIERRE FABRE
BG
not available
20100098
SAS PIERRE FABRE
PL
MEDICAMENT
pentru soluţie perfuzabilă Навелбин 20 mg меки капсули
PIERRE FABRE
MEDICAMENT
sporządzania roztworu do infuzji Navelbine 10 mg/ml concentrat
RO
MEDICAMENT
инфузионен разтвор Navelbine, 10 mg/ml, koncentrat do
SAS PIERRE FABRE MEDICAMENT
injectable en flacon Навелбин 10 mg/ml концентрат за
RO
MEDICAMENT
pentru soluţie perfuzabilă NAVELBINE 10 mg/1 ml, solution
GR
SAS PIERRE FABRE
RO
MEDICAMENT PIERRE FABRE
BG
MEDICAMENT Navelbine 20 mg lágy kapszula
not available
OGYI-T-472 1/03
PIERRE FABRE
HU
MEDICAMENT Навелбин 30 mg меки капсули
not available
20100099
PIERRE FABRE
BG
MEDICAMENT Navelbine 30 mg lágy kapszula
not available
OGYI-T-4721/04
PIERRE FABRE
Navelbine 30 mg mjúk hylki
not available
IS/1/03/135/02
PIERRE FABRE PHARMA
Navelbine 80 mg mjúk hylki
not available
IS/1/03/135/04
PIERRE FABRE PHARMA
HU
MEDICAMENT IS
NORDEN AB/SW IS
NORDEN AB/SW
List of nationally authorised medicinal products EMA/795271/2017
Page 5/9
Product Name (in authorisation
MRP/DCP Authorisation
National
MAH of product in the
Member State where
country)
number
Authorisation Number
member state
product is authorised
Navelbine 10 mg/ml
not available
960118
PIERRE FABRE PHARMA
IS
innrennslisþykkni, lausn
NORDEN AB/SW
Navelbine 20 mg mjúk hylki
not available
IS/1/03/135/01
Navelbine 10 mg/ml
not available
12191
not available
15882
PIERRE FABRE PHARMA
IS
NORDEN AB/SW infuusiokonsentraatti, liuosta varten NAVELBINE ® 20 mg kapseli,
not available
15883
FI
PIERRE FABRE PHARMA
FI
NORDEN AB/SW not available
15884
pehmeä NAVELBINE ® 80 mg kapseli,
PIERRE FABRE PHARMA NORDEN AB
pehmeä NAVELBINE ® 40 mg kapseli,
FI
NORDEN AB
pehmeä NAVELBINE ® 30 mg kapseli,
PIERRE FABRE PHARMA
PIERRE FABRE PHARMA
FI
NORDEN AB/SW not available
15885
not available
PA 1287/001/005
NAVELBINE® 20 mg soft capsule
not available
PA 1287/001/001
PIERRE FABRE LIMITED
IE
NAVELBINE® 30 mg soft capsule
not available
PA 1287/001/002
PIERRE FABRE LIMITED
IE
NAVELBINE® 80 mg soft capsule
not available
PA 1287/001/004
PIERRE FABRE LIMITED /
IE
pehmeä NAVELBINE 10 mg / ml concentrate
PIERRE FABRE PHARMA
FI
NORDEN AB/SW
for solution for infusion
PIERRE FABRE LIMITED /
IE
UK
UK NAVELBINE 10 mg / 1 ml
not available
33071.00.00
Konzentrat zur Herstellung einer
PIERRE FABRE PHARMA
DE
GMBH
Infusionslösung NAVELBINE 20 mg Weichkapseln
not available
50133.00.00
PIERRE FABRE PHARMA
DE
GMBH NAVELBINE 30 mg Weichkapseln
not available
50133.01.00
PIERRE FABRE PHARMA
DE
GMBH NAVELBINE 80 mg Weichkapseln
not available
50133.03.00
PIERRE FABRE PHARMA
DE
GMBH List of nationally authorised medicinal products EMA/795271/2017
Page 6/9
Product Name (in authorisation
MRP/DCP Authorisation
National
MAH of product in the
Member State where
country)
number
Authorisation Number
member state
product is authorised
NAVELBINE 50 mg / 5 ml
not available
33071.02.00
PIERRE FABRE PHARMA
DE
Konzentrat zur Herstellung einer
GMBH
Infusionslösung NAVELBINE 20 mg, capsule molle
not available
34009 365 948 4 5
SAS PIERRE FABRE
FR
MEDICAMENT NAVELBINE 30 mg, capsule molle
not available
34009 365 949 0 6
SAS PIERRE FABRE
FR
MEDICAMENT NAVELBINE 50 mg/5 ml, solution
not available
34009 331 845 8 2
not available
34009 331 903 8 5
not available
34009 331 904 4 6
injectable en flacon NAVELBINE 10 mg/1 ml, solution
FR
SAS PIERRE FABRE
FR
MEDICAMENT not available
34009 331 844 1 4
injectable en flacon NAVELBINE 50 mg/5 ml
SAS PIERRE FABRE MEDICAMENT
injectable en flacon NAVELBINE 50 mg/5 ml, solution
FR
MEDICAMENT
injectable en flacon NAVELBINE 10 mg/1 ml, solution
PIERRE FABRE
SAS PIERRE FABRE
FR
MEDICAMENT not available
59.299
concentrado para solución para
PIERRE FABRE IBERICA,
ES
S.A.
perfusión NAVELBINE 20 mg cápsulas blandas
not available
65.978
PIERRE FABRE IBERICA,
ES
S.A. NAVELBINE 30 mg cápsulas blandas
not available
65.979
PIERRE FABRE IBERICA,
ES
S.A. NAVELBINE 10 mg/ml concentrado
not available
59.300
para solución para perfusión Navelbine 10 mg/ml koncentratas
kapsulės
List of nationally authorised medicinal products EMA/795271/2017
ES
S.A. not available
LT/1/97/2874/001
infuziniam tirpalui NAVELBINE 20 mg minkštosios
PIERRE FABRE IBERICA, SAS PIERRE FABRE
LT
MEDICAMENT not available
LT/1/97/2874/005
SAS PIERRE FABRE
LT
MEDICAMENT
Page 7/9
Product Name (in authorisation
MRP/DCP Authorisation
National
MAH of product in the
Member State where
country)
number
Authorisation Number
member state
product is authorised
NAVELBINE 30 mg minkštosios
not available
LT/1/97/2874/006
SAS PIERRE FABRE
LT
kapsulės Navelbine 10 mg/ml koncentratas
MEDICAMENT not available
LT/1/97/2874/002
SAS PIERRE FABRE
not available
LT/1/97/2874/003
SAS PIERRE FABRE
not available
LT/1/97/2874/004
infuziniam tirpalui Navelbine 10 mg/ml koncentratas
MEDICAMENT
infuziniam tirpalui Navelbine 10 mg/ml koncentratas
LT LT
MEDICAMENT
infuziniam tirpalui
SAS PIERRE FABRE
LT
MEDICAMENT
NAVELBINE® 20 mg soft capsule
not available
PL 00603/0029
PIERRE FABRE LIMITED
UK
NAVELBINE® 30 mg soft capsule
not available
PL 00603/0030
PIERRE FABRE LIMITED
UK
NAVELBINE® 80 mg soft capsule
not available
PL 00603/0032
PIERRE FABRE LIMITED
UK
NAVELBINE® 10 mg/ml
not available
PL 00603/0028
PIERRE FABRE LIMITED
UK
not available
854914
SAS PIERRE FABRE
EE
concentrate for solution for infusion NAVELBINE 20 mg pehmekapsel
MEDICAMENT NAVELBINE 30 mg pehmekapsel
not available
854814
Navelbine, 10 mg/ml
not available
310300
not available
1-20425
SAS PIERRE FABRE
EE
MEDICAMENT infusioonilahuse kontsentraat Navelbine® 10 mg -
EE
MEDICAMENT
Infusionskonzentrat Navelbine® 20 mg - Kapseln
SAS PIERRE FABRE SAS PIERRE FABRE
AT
MEDICAMENT not available
1-24690
PIERRE FABRE
AT
MEDICAMENT Navelbine® 30 mg - Kapseln
not available
1-24691
PIERRE FABRE
AT
MEDICAMENT Navelbine® 80 mg - Kapseln
not available
1-24693
Navelbine® 40 mg -
not available
1-20427
PIERRE FABRE
AT
MEDICAMENT Infusionskonzentrat List of nationally authorised medicinal products EMA/795271/2017
PIERRE FABRE
AT
MEDICAMENT
Page 8/9
Product Name (in authorisation
MRP/DCP Authorisation
National
MAH of product in the
Member State where
country)
number
Authorisation Number
member state
product is authorised
Navelbine® 50 mg -
not available
1-20428
PIERRE FABRE
AT
Infusionskonzentrat Navelbine 10mg/ml, concentrate for
MEDICAMENT not available
017884
not available
44/0131/02-S
not available
44/0132/02-S
solution for infusion NAVELBINE ORAL 20 mg mäkké
SK
PIERRE FABRE
SK
MEDICAMENT not available
44/0136/92-S
koncentrát NAVELBINE 80 mg capsules, zacht
PIERRE FABRE MEDICAMENT
kapsuly NAVELBINE 10 mg infúzny
CY
HADJIGREGORIOU LTD
kapsuly NAVELBINE ORAL 30 mg mäkké
GREGORIS
PIERRE FABRE
SK
MEDICAMENT not available
RVG111395
PIERRE FABRE
NL
MEDICAMENT NAVELBINE 10 mg/ml, concentraat
not available
RVG 18020
NAVELBINE 30 mg capsules, zacht
not available
RVG111394
NAVELBINE 20 mg capsules, zacht
not available
RVG 111393
voor oplossing voor infusie
SAS PIERRE FABRE
NL
MEDICAMENT PIERRE FABRE
NL
MEDICAMENT SAS PIERRE FABRE
NL
MEDICAMENT NAVELBINE koncentrát pro infuzní
not available
44/ 136/ 92-S/C
roztok NAVELBINE ORAL 20 mg Měkké
tobolky
List of nationally authorised medicinal products EMA/795271/2017
CZ
MEDICAMENT not available
44/238/02-C
tobolky NAVELBINE ORAL 30 mg Mekké
PIERRE FABRE PIERRE FABRE
CZ
MEDICAMENT not available
44/239/02-C
PIERRE FABRE
CZ
MEDICAMENT
Page 9/9