30 November 2017 EMA/795271/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: vinorelbine

Procedure no.: PSUSA/00003124/201704

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

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

vinorelbine PSUSA-00003124-201704 ... - European Medicines Agency

Nov 30, 2017 - List of nationally authorised medicinal products. EMA/795271/2017. Page 2/9. 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. Navelbine 50 mg/5 ml solution à.

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