List of nationally authorised medicinal products

Transcription

1 30 November 2017 EMA/795271/2017 Human Medicines Evaluation Division Active substance: vinorelbine Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 Navelbine 50 mg/5 ml solution à diluer pour perfusion Navelbine, koncentrat til infusionsvæske, opløsning Navelbine 10 mg/ml, ενέσιμο διάλυμα Navelbine 10 mg/ml koncentrátum oldatos infúzióhoz NAVELBINE 10 mg/ml concentrato per soluzione per infusione NAVELBINE 10 mg/ml koncentrāts infūziju šķīduma pagatavošanai Navelbine 10 mg/ml koncentrat till infusionsvätska, lösning not available SAS PIERRE FABRE not available PIERRE FABRE PHARMA DK not available 41571/ PIERRE FABRE FARMAKA GR SA not available OGYI-T-4721/01 SAS PIERRE FABRE HU not available PIERRE FABRE PHARMA IT S.R.L. not available PIERRE FABRE LV not available PIERRE FABRE PHARMA SE NAVELBINE 20 mg capsules molles not available PIERRE FABRE Navelbine, bløde kapsler not available PIERRE FABRE PHARMA DK NAVELBINE 20 mg μαλακό καψάκιο not available PIERRE FABRE FARMAKA / GR GREECE NAVELBINE 20 mg capsule molli not available 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 PL NAVELBINE 20 mg, cápsula mole not available PFM / PORTUGAL PT NAVELBINE 20 mg capsule moi not available 6075/2005/01 PIERRE FABRE EMA/795271/2017 Page 2/9

3 Navelbine 20 mg mjuk kapsel not available PIERRE FABRE PHARMA SE NAVELBINE 30 mg capsules molles not available PIERRE FABRE Navelbine, bløde kapsler not available PIERRE FABRE PHARMA DK NAVELBINE 30 mg μαλακό καψάκιο not available 41580/ PIERRE FABRE FARMAKA / GR GREECE NAVELBINE 30 mg capsule molli not available PFM PHARMA / ITALY IT NAVELBINE 30 mg, capsule molle not available 0724/01/12/0035 PIERRE FABRE LU Navelbine, kapsułka miękka, 30 mg not available 9451 SAS PIERRE FABRE PL NAVELBINE 30 mg, cápsula mole not available PFM / PORTUGAL PT NAVELBINE 30 mg capsule moi not available 6076/2005/01 SAS PIERRE FABRE Navelbine 30 mg mjuk kapsel not available PIERRE FABRE PHARMA SE Navelbine, bløde kapsler not available PIERRE FABRE PHARMA DK Navelbine 80 mg mjuk kapsel not available PIERRE FABRE PHARMA SE Navelbine20 mg kapsel, myk not available 02/1154 PIERRE FABRE PHARMA NO Navelbine80 mg kapsel, myk not available 02/1157 PIERRE FABRE PHARMA NO Navelbine30 mg kapsel, myk not available 02/1155 PIERRE FABRE PHARMA NO EMA/795271/2017 Page 3/9

4 Navelbine 10 mg/ml, konsentrat til not available PIERRE FABRE PHARMA NO infusjonsvæske Navelbine 50 mg/5 ml concentraat not available SAS PIERRE FABRE voor oplossing voor intraveneuze infusie NAVELBINE 30 mg capsules, zacht not available PIERRE FABRE NAVELBINE 20 mg capsules, zacht not available PIERRE FABRE Navelbine 10 mg/ml koncentrátum not available OGYI-T-4721/02 SAS PIERRE FABRE HU oldatos infúzióhoz NAVELBINE 50 mg/5 ml, solution not available 0724/ PIERRE FABRE LU NAVELBINE 30 mg capsule moi not available 6076/2005/02 PIERRE FABRE NAVELBINE 10 mg/ml concentrato not available PFM PHARMA / ITALY IT per soluzione per infusione NAVELBINE 20 mg capsule moi not available 6075/2005/02 PIERRE FABRE Navelbine 40 mg/4 ml solution à not available SAS PIERRE FABRE diluer pour perfusion Navelbine 10 mg/1 ml solution à not available SAS PIERRE FABRE diluer pour perfusion Navelbine 40 mg/4 ml concentraat not available SAS PIERRE FABRE voor oplossing voor intraveneuze infusie Navelbine 10 mg/1 ml concentraat voor oplossing voor intraveneuze infusie not available SAS PIERRE FABRE EMA/795271/2017 Page 4/9

5 Navelbine 10 mg/ml, ενέσιμο διάλυμα not available 41576/ PIERRE FABRE FARMAKA SA Navelbine 10 mg/ml, ενέσιμο not available 41578/ PIERRE FABRE FARMAKA διάλυμα SA Navelbine 10 mg/ml concentrat not available 4661/2012/02 SAS PIERRE FABRE pentru soluţie perfuzabilă Navelbine 10 mg/ml concentrat not available 4661/2012/03 SAS PIERRE FABRE pentru soluţie perfuzabilă NAVELBINE 10 mg/1 ml, solution not available 0724/ PIERRE FABRE Навелбин 10 mg/ml концентрат за not available PIERRE FABRE инфузионен разтвор Navelbine, 10 mg/ml, koncentrat do not available R/1736 SAS PIERRE FABRE sporządzania roztworu do infuzji Navelbine 10 mg/ml concentrat not available 4661/2012/01 SAS PIERRE FABRE pentru soluţie perfuzabilă Навелбин 20 mg меки капсули not available PIERRE FABRE Navelbine 20 mg lágy kapszula not available OGYI-T-472 1/03 PIERRE FABRE Навелбин 30 mg меки капсули not available PIERRE FABRE 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 GR GR LU BG PL BG HU BG HU IS IS EMA/795271/2017 Page 5/9

6 Navelbine 10 mg/ml not available PIERRE FABRE PHARMA IS innrennslisþykkni, lausn Navelbine 20 mg mjúk hylki not available IS/1/03/135/01 PIERRE FABRE PHARMA IS Navelbine 10 mg/ml infuusiokonsentraatti, liuosta varten NAVELBINE 20 mg kapseli, pehmeä NAVELBINE 30 mg kapseli, pehmeä NAVELBINE 40 mg kapseli, pehmeä NAVELBINE 80 mg kapseli, pehmeä NAVELBINE 10 mg / ml concentrate for solution for infusion not available PIERRE FABRE PHARMA FI not available PIERRE FABRE PHARMA FI not available PIERRE FABRE PHARMA FI not available PIERRE FABRE PHARMA FI not available PIERRE FABRE PHARMA FI not available PA 1287/001/005 PIERRE FABRE LIMITED / IE UK 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 UK NAVELBINE 10 mg / 1 ml not available PIERRE FABRE PHARMA DE Konzentrat zur Herstellung einer Infusionslösung NAVELBINE 20 mg Weichkapseln not available PIERRE FABRE PHARMA DE NAVELBINE 30 mg Weichkapseln not available PIERRE FABRE PHARMA DE NAVELBINE 80 mg Weichkapseln not available PIERRE FABRE PHARMA DE EMA/795271/2017 Page 6/9

7 NAVELBINE 50 mg / 5 ml Konzentrat zur Herstellung einer Infusionslösung not available PIERRE FABRE PHARMA NAVELBINE 20 mg, capsule molle not available SAS PIERRE FABRE NAVELBINE 30 mg, capsule molle not available SAS PIERRE FABRE NAVELBINE 50 mg/5 ml, solution not available PIERRE FABRE NAVELBINE 10 mg/1 ml, solution not available SAS PIERRE FABRE NAVELBINE 10 mg/1 ml, solution not available SAS PIERRE FABRE NAVELBINE 50 mg/5 ml, solution not available SAS PIERRE FABRE NAVELBINE 50 mg/5 ml not available PIERRE FABRE IRICA, concentrado para solución para S.A. perfusión NAVELBINE 20 mg cápsulas blandas not available PIERRE FABRE IRICA, S.A. NAVELBINE 30 mg cápsulas blandas not available PIERRE FABRE IRICA, S.A. NAVELBINE 10 mg/ml concentrado not available PIERRE FABRE IRICA, para solución para perfusión S.A. Navelbine 10 mg/ml koncentratas not available /1/97/2874/001 SAS PIERRE FABRE infuziniam tirpalui NAVELBINE 20 mg minkštosios not available /1/97/2874/005 SAS PIERRE FABRE kapsulės DE ES ES ES ES EMA/795271/2017 Page 7/9

8 NAVELBINE 30 mg minkštosios not available /1/97/2874/006 SAS PIERRE FABRE kapsulės Navelbine 10 mg/ml koncentratas not available /1/97/2874/002 SAS PIERRE FABRE infuziniam tirpalui Navelbine 10 mg/ml koncentratas not available /1/97/2874/003 SAS PIERRE FABRE infuziniam tirpalui Navelbine 10 mg/ml koncentratas not available /1/97/2874/004 SAS PIERRE FABRE infuziniam tirpalui 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 concentrate for solution for infusion NAVELBINE 20 mg pehmekapsel not available SAS PIERRE FABRE EE NAVELBINE 30 mg pehmekapsel not available SAS PIERRE FABRE EE Navelbine, 10 mg/ml not available SAS PIERRE FABRE EE infusioonilahuse kontsentraat Navelbine 10 mg - not available SAS PIERRE FABRE Infusionskonzentrat Navelbine 20 mg - Kapseln not available PIERRE FABRE Navelbine 30 mg - Kapseln not available PIERRE FABRE Navelbine 80 mg - Kapseln not available PIERRE FABRE Navelbine 40 mg - Infusionskonzentrat not available PIERRE FABRE EMA/795271/2017 Page 8/9

9 Navelbine 50 mg - Infusionskonzentrat not available PIERRE FABRE Navelbine 10mg/ml, concentrate for not available GREGORIS solution for infusion HADJIGREGORIOU D NAVELBINE ORAL 20 mg mäkké not available 44/0131/02-S PIERRE FABRE kapsuly NAVELBINE ORAL 30 mg mäkké not available 44/0132/02-S PIERRE FABRE kapsuly NAVELBINE 10 mg infúzny not available 44/0136/92-S PIERRE FABRE koncentrát NAVELBINE 80 mg capsules, zacht not available RVG PIERRE FABRE NAVELBINE 10 mg/ml, concentraat not available RVG SAS PIERRE FABRE voor oplossing voor infusie NAVELBINE 30 mg capsules, zacht not available RVG PIERRE FABRE NAVELBINE 20 mg capsules, zacht not available RVG SAS PIERRE FABRE NAVELBINE koncentrát pro infuzní not available 44/ 136/ 92-S/C PIERRE FABRE roztok NAVELBINE ORAL 20 mg Měkké not available 44/238/02-C PIERRE FABRE tobolky NAVELBINE ORAL 30 mg Mekké not available 44/239/02-C PIERRE FABRE tobolky CY SK SK SK NL NL NL NL CZ CZ CZ EMA/795271/2017 Page 9/9