List of nationally authorised medicinal products

Transcription

1 12 April 2018 EMA/223740/2018 Human Medicines Evaluation Division Active substance: fludarabine 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 Fludarabine Accord Healthcare 25 mg/ml solution à diluer pour solution injectable /pour perfusion Fludarabine Accord Healthcare 25 mg/ml Concentraat voor oplossing voor injectie of infusie Fludarabine Accord 25 mg/ml, süste- või infusioonilahuse kontsentraat Fludarabin Accord 25 mg/ml koncentrátum oldatos injekcióhoz vagy infúzióhoz Fludarabin Accord 25 mg/ml koncentrátum oldatos injekcióhoz vagy infúzióhoz Fludarabin Accord 25 mg/ml koncentrátum oldatos injekcióhoz vagy infúzióhoz Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion UK/H/5564/001 BE ACCORD HEALTHCARE UK/H/5564/001 BE ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/001 OGYI-T-22726/01 ACCORD HEALTHCARE UK/H/5564/001 OGYI-T-22726/02 ACCORD HEALTHCARE UK/H/5564/001 OGYI-T-22726/03 ACCORD HEALTHCARE UK/H/5564/001 PA 1390/096/001 ACCORD HEALTHCARE BE BE EE HU HU HU IE EMA/223740/2018 Page 2/18

3 FludarabineAccord 25 mg/ml koncentratas injekciniam ar infuziniam tirpalui FludarabineAccord 25 mg/ml koncentratas injekciniam ar infuziniam tirpalui FludarabineAccord 25 mg/ml koncentratas injekciniam ar infuziniam tirpalui Fludarabine Accord 25 mg/ml koncentrats injekciju vai infuziju škiduma pagatavošanai Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion Fludarabinefosfaat Accord 25 mg/ml, concentraat voor oplossing voor injectie of infusie Fludarabine Accord 25 mg/ml Koncentrat till injektions- /infusionsvätska, lösning UK/H/5564/001 LT/1/14/3627/001 ACCORD HEALTHCARE UK/H/5564/001 LT/1/14/3627/002 ACCORD HEALTHCARE UK/H/5564/001 LT/1/14/3627/003 ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/001 MA 054/08401 ACCORD HEALTHCARE UK/H/5564/001 RVG ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE LT LT LT LV MT NL SE EMA/223740/2018 Page 3/18

4 Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion Fludarabin Accord 25 mg/ml Konzentrat zur Herstellung einer Injektions oder Infusionslösung Fludarabin Accord 25 mg/ml Konzentrat zur Herstellung einer Injektions- /Infusionslösung Fludarabina Accord 25mg/ml concentrado para solução injetável ou para perfusão Fludarabina Accord 25mg/ml concentrado para solução injetável ou para perfusão Fludarabina Accord 25mg/ml concentrado para solução injetável ou para perfusão UK/H/5564/001 PL 20075/0379 ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK AT DE PT PT PT EMA/223740/2018 Page 4/18

5 Fludarabina Accord 25 mg/ml concentrado para solución inyectable y para perfusión. Fludarabina Accord 25 mg/ml Concentrato per soluzione iniettabile o per infusione Fludarabina Accord 25 mg/ml Concentrato per soluzione iniettabile o per infusione Fludarabina Accord 25 mg/ml Concentrato per soluzione iniettabile o per infusione Fludarabine Accord 25 mg/ml koncentrát pro injekční/infuzní roztok Fludarabine Accord 25 mg/ml πυκνό διάλυμα για παρασκευή διαλύματος προς ένεση ή έγχυση Fludarabin Accord 25 mg/ml koncentrat za otopinu za injekciju ili infuziju UK/H/5564/ ACCORD HEALTHCARE S.L.U. ES UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/001 44/476/15-C ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/001 HR-H ACCORD HEALTHCARE IT IT IT CZ CY HR EMA/223740/2018 Page 5/18

6 Fludarabine Accord, 25 mg/ml, koncentrat do sporządzania roztworu do wstrzykiwań lub infuzji Fludarabine Accord 25 mg/ml injektio- /infuusiokonsentraatti, liuosta varten Флударабин Акорд 25 mg/ml концентрат за инжекционен или инфузионен разтвор Fludarabinmedac 25 mg/ml Konzentrat zur Herstellung einer Injektionslösung oder Infusionslösung Fludarabine Teva 25 mg/ml, concentraat voor oplossing voor intraveneuze injectie/infusie Fludarabinphosphat OMNICARE 25 mg/ml Konzentrat zur Herstellung einer Injektionslösung oder Infusionslösung UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE UK/H/5564/ ACCORD HEALTHCARE NL/H/0805/ PHARMACHEMIE B.V DE NL-H RVG TEVA NEDERLAND B.V. NL not available OMNICARE PHARMA GMBH DE PL FI BG EMA/223740/2018 Page 6/18

7 Fludarabin Teva 25 mg/ml koncentrat za raztopino za injiciranje ali infundiranje Fludarabine Teva, 25 mg/ml, koncentrat do sporządzania roztworu do wstrzykiwań lub infuzji Fludarabina Teva 25mg/ml concentrato per soluzione iniettabile o per infusione Fludarabinphosphat Phar machemie, koncentrat til injektions- og infusionsvæske, opløsning Fludarabine-Teva 25 mg/ml, koncentrát pro injekční/infuzní roztok Fludarabina Teva 25 mg/ml, concentrado para solución inyectable y para perfusión EFG NL/H/0715/001 H/07/00630/001 TEVA PHARMA B.V. SI NL/H/0715/ TEVA PHARMACEUTICALS POLSKA SP. Z O.O. NL/H/0715/ TEVA ITALIA S.R.L. IT NL/H/0715/ PHARMACHEMIE B.V DK NL/H/0715/001 44/333/07-C TEVA PHARMACEUTICALS CR, S.R.O. NL/H/0715/ TEVA PHARMA S.L.U ES PL CZ EMA/223740/2018 Page 7/18

8 Fludarabinphosphat- GRY 25 mg/ml Konzentrat zur Herstellung einer Injektionslösung oder Infusionslösung FLUDARABINE TEVA 25 mg/ml, solution à diluer pour injectable ou perfusion Fludarabinefosfaat - PCH 25 mg/ml, concentraat voor oplossing voor infusie of injectie Fludarabine Teva 25 mg/ml concentraat voor oplossing voor injectie of infusie Fludarabine Phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion Fludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusion Fludara 10 mg plėvele dengtos tabletės NL/H/0715/ TEVA GMBH DE NL/H/0715/001 NL32376 TEVA SANTÉ FR NL/H/0715/001 RVG PHARMACHEMIE B.V NL NL/H/0715/001 BE TEVA PHARMA BELGIUM N.V./S.A NL/H/0715/001 PL 00289/0938 TEVA UK UK NL/H/0715/ TEVA PHARMA BELGIUM N.V./S.A not available LT/1/96/2819/002 GENZYME EUROPE B.V. LT BE LU EMA/223740/2018 Page 8/18

9 FLUDARA 10 mg, comprimé pelliculé Fludara oral 10 mg filmcoated tablets Fludara oral 10 mg filmcoated tablets FLUDARA 10 mg, comprimé pelliculé FLUDARA 10 mg, comprimé pelliculé Fludara 50 mg poudre pour solution injectable ou poudre pour solution pour perfusion Fludara 50 mg poeder voor oplossing voor injectie of infusie Fludara 50 mg por oldatos injekcióhoz vagy oldatos infúzióhoz Fludara 50 mg polvere per soluzione iniettabile o per infusion Fludara 50 mg powder for solution for injection/infusion UK/H/0055/ GENZYME EUROPE B.V. LU UK/H/0055/002 PL 12375/0040 GENZYME EUROPE B.V. UK UK/H/0055/002 PA 611/4/2 GENZYME EUROPE B.V. IE UK/H/0055/ GENZYME EUROPE B.V. FR UK/H/0055/ GENZYME EUROPE B.V. FR UK/H/0055/001 BE GENZYME EUROPE B.V. BE UK/H/0055/001 BE GENZYME EUROPE B.V. BE not available OGYI-T 8272/03 GENZYME EUROPE B.V. HU UK/H/0055/ GENZYME EUROPE B.V. IT not available MA596/00301 GENZYME EUROPE B.V. MT EMA/223740/2018 Page 9/18

10 Fludara, poeder voor oplossing voor injectie of infusie 50 mg/flacon Fludara 50 mg pó para solução injectável ou para perfusão Fludara 50 mg prašek za raztopino za injiciranje ali infundiranje Beneflur 50 mg polvo para solución inyectable y para perfusion Fludara 50 mg κόνις για ενέσιμο διάλυμα ή για διάλυμα προς έγχυση Fludara 50 mg κόνις για ενέσιμο διάλυμα ή για διάλυμα προς έγχυση Флудара орал 10 mg филмирани таблетки Fludara 10 mg επικαλυμμένα με λεπτό υμένιο δισκία Fludara 10 mg, potahované tablety Fludara, filmovertrukne tabletter UK/H/0055/001 RVG GENZYME EUROPE B.V. NL UK/H/0055/ GENZYME EUROPE B.V. PT not available H/97/00628/001 GENZYME EUROPE B.V. SI UK/H/0055/ GENZYME EUROPE B.V. ES not available GENZYME EUROPE B.V. CY UK/H/0055/ / GENZYME EUROPE B.V. GR not available ; II-1214/ GENZYME EUROPE B.V. BG not available GENZYME EUROPE B.V. CY not available 44/181/01-C GENZYME EUROPE B.V. CZ UK/H/0055/ GENZYME EUROPE B.V. DK EMA/223740/2018 Page 10/18

11 Fludara 10 mg tabletti, kalvopäällysteinen Fludara 10 mg επικαλυμμένα με λεπτό υμένιο δισκία Fludara 10 mg filmtabletta Fludara 10 mg filmtabletta Fludara 10 mg filmuhúðaðar töflur Fludara 10 mg compresse rivestite con film Fludara 10 mg compresse rivestite con film Fludara 10 mg apvalkotās tabletes Fludara 10 mg plėvele dengtos tabletės FLUDARA 10 mg, comprimé pelliculé Fludara oral 10 mg filmcoated tablets Fludara oraal 10 mg, filmomhulde tabletten Fludara 10 mg tablett, filmdrasjert UK/H/0055/ GENZYME EUROPE B.V. FI UK/H/0055/ / GENZYME EUROPE B.V. GR not available OGYI-T-8272/01 GENZYME EUROPE B.V. HU not available OGYI-T-8272/02 GENZYME EUROPE B.V. HU UK/H/0055/002 IS/1/01/036/01 GENZYME EUROPE B.V. IS UK/H/0055/ GENZYME EUROPE B.V. IT UK/H/0055/ GENZYME EUROPE B.V. IT not available GENZYME EUROPE B.V. LV not available LT/1/96/2819/001 GENZYME EUROPE B.V. LT UK/H/0055/ GENZYME EUROPE B.V. LU not available MA596/00302 GENZYME EUROPE B.V. MT UK/H/0055/002 RVG GENZYME EUROPE B.V. NL UK/H/0055/ GENZYME EUROPE B.V. NO EMA/223740/2018 Page 11/18

12 Fludara Oral, 10 mg, tabletki powlekane Fludara oral 10 mg, comprimate filmate Fludara oral 10 mg, comprimate filmate Fludara oral 10 mg filmom obalené tablety Fludara 10 mg filmsko obložene tablete Beneflur10 mg comprimidos recubiertos con película Fludara 10 mg filmdragerad tablett Fludara 50 mg powder for solution for injection/infusion Fludara 50 mg Pulver zur Herstellung einer Injektions- oder Infusionslosung FLUDARA 50 mg, poudre pour solution injectable ou perfusion Fludara 50 mg powder for solution for injection/infusion not available GENZYME EUROPE B.V. PL not available 1229/2008/01 GENZYME EUROPE B.V. RO not available 1229/2008/02 GENZYME EUROPE B.V. RO not available 44/0001/03-S GENZYME EUROPE B.V. SK not available H/97/00628/002 GENZYME EUROPE B.V. SI UK/H/0055/ GENZYME EUROPE B.V. ES UK/H/0055/ GENZYME EUROPE B.V. SE UK/H/0055/001 PA 611/4/1 GENZYME EUROPE B.V. IE UK/H/0055/ GENZYME EUROPE B.V. DE UK/H/0055/ GENZYME EUROPE B.V. FR UK/H/0055/001 PL 12375/0039 GENZYME EUROPE B.V. UK EMA/223740/2018 Page 12/18

13 Fludara 10 mg επικαλυμμένα με λεπτό υμένιο δισκία Флудара орал 10 mg филмирани таблетки Fludara oral 10 mg filmom obalené tablety Fludara 10 mg apvalkotās tabletes Fludara oral 10 mg filmcoated tablets Fludara Oral, 10 mg, tabletki powlekane Fludara 10 mg, potahované tablety Fludara oral 10 mg filmcoated tablets Fludara 10 mg επικαλυμμένα με λεπτό υμένιο δισκία Fludara 10 mg tablett, filmdrasjert Fludara oral 10 mg filmcoated tablets Fludara, filmovertrukne tabletter Fludara 10 mg filmuhúðaðar töflur not available GENZYME EUROPE B.V. CY not available ; II-1214/ GENZYME EUROPE B.V. BG not available 44/0001/03-S GENZYME EUROPE B.V. SK not available GENZYME EUROPE B.V. LV not available MA596/00302 GENZYME EUROPE B.V. MT not available GENZYME EUROPE B.V. PL not available 44/181/01-C GENZYME EUROPE B.V. CZ UK/H/0055/002 PL 12375/0040 GENZYME EUROPE B.V. UK UK/H/0055/ / GENZYME EUROPE B.V. GR UK/H/0055/ GENZYME EUROPE B.V. NO UK/H/0055/002 PA 611/4/2 GENZYME EUROPE B.V. IE UK/H/0055/ GENZYME EUROPE B.V. DK UK/H/0055/002 IS/1/01/036/01 GENZYME EUROPE B.V. IS EMA/223740/2018 Page 13/18

14 Fludara 10 mg tabletti, kalvopäällysteinen Beneflur10 mg comprimidos recubiertos con película Fludara oraal 10 mg, filmomhulde tabletten Fludarabin Actavis 25 mg/ml koncentrat till injektions- /infusionsvätska, lösning Fludarabin Actavis 25mg/ml concentrate for solution for injection or infusion Fludarabin Actavis 25mg/ml concentrate for solution for injection or infusion Fludarabine Actavis, 25 mg/ml, süste- või infusioonilahuse kontsentraat FLUDARABINE ACTAVIS 25 MG/ML KONCENTRĀTS INJEKCIJU VAI INFŪZIJU ŠĶĪDUMA PAGATAVOŠANAI UK/H/0055/ GENZYME EUROPE B.V. FI UK/H/0055/ GENZYME EUROPE B.V. ES UK/H/0055/002 RVG GENZYME EUROPE B.V. NL UK/H/5290/ ACTAVIS GROUP PTC EHF. SE UK/H/5290/ ACTAVIS GROUP PTC EHF. NO UK/H/5290/001 PA 1380/134/1 ACTAVIS GROUP PTC EHF. IE UK/H/5290/ ACTAVIS GROUP PTC EHF. EE UK/H/5290/ ACTAVIS GROUP PTC EHF. LV EMA/223740/2018 Page 14/18

15 Fludarabine/Actavis 25 mg/ml, πυκνό διάλυμα για παρασκευή ενέσιμου διαλύματος ή διαλύματος προς έγχυση Fludarabin Actavis 25 mg/ml injektio- /infuusiokonsentraatti, liuosta varten Fludarabinefosfaat Aurobindo 25 mg/ml, concentraat voor oplossing voor injectie of infusie Fludarabin Actavis 25 mg/ml koncentrat za raztopino za injiciranje/infundiranje FLUDARABINA AUROBINDO 25 mg/ml concentrato per soluzione iniettabile o per infusione FLUDARABINA AUROBINDO 25 mg/ml concentrato per soluzione iniettabile o per infusione UK/H/5290/ / ACTAVIS GROUP PTC EHF. GR UK/H/5290/ ACTAVIS GROUP PTC EHF. FI UK/H/5290/001 RVG AUROBINDO PHARMA B.V. NL UK/H/5290/001 H/13/00629/002 ACTAVIS GROUP PTC EHF. SI UK/H/5290/ AUROBINDO PHARMA (ITALIA) S.R.L. UK/H/5290/ AUROBINDO PHARMA (ITALIA) S.R.L. IT IT EMA/223740/2018 Page 15/18

16 Fludarabina Aurovitas 25 mg/ml concentrado para solución inyectable y para perfusión Fludarabin Aurobindo 25 mg/ml Konzentrat zur Herstellung einer Injektionslösung oder Infusionslösung Fludarabine Actavis, 25 mg/ml, koncentrat do sporzadzania roztworu do wstrzykiwan/do infuzji Флударабин Актавис 25 mg/ml концентрат за инжекционен или инфузионен разтвор Fludarabin Actavis 25mg/ml concentrate for solution for injection or infusion Fludarabine Actavis 25 mg/ml koncentratas injekciniam/infuziniam tirpalui UK/H/5290/ AUROVITAS SPAIN,S.A.U. ES UK/H/5290/ PUREN PHARMA GMBH & CO. KG UK/H/5290/ ACTAVIS GROUP PTC EHF. PL UK/H/5290/ ACTAVIS GROUP PTC EHF. BG UK/H/5290/001 IS/1/13/061/01 ACTAVIS GROUP PTC EHF. IS UK/H/5290/001 LT/1/13/3338/ ACTAVIS GROUP PTC EHF. LT DE EMA/223740/2018 Page 16/18

17 Fludarabine Actavis 25 mg/ml concentrat pentru solutie injectabila sau perfuzabila Fludarabine Phosphate 25mg/ml Concentrate for Solution for Injection or Infusion Fludarabinphosphat "Actavis", koncentrat til injektions- og infusionsvæske, opløsning Fludarabinphosphat Actavis 25 mg/ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösung Fludarabin Actavis 25 mg/ml koncentrat za raztopino za injiciranje/infundiranje Fludarabine/Teva 25 mg/ml, πυκνό διάλυμα για παρασκευή ενέσιμου διαλύματος ή διαλύματος προς έγχυση UK/H/5290/ /2013/01-02 ACTAVIS GROUP PTC EHF. RO UK/H/5290/001 PL 30306/0442 ACTAVIS GROUP PTC EHF. UK UK/H/5290/ ACTAVIS GROUP PTC EHF. DK UK/H/5290/ ACTAVIS GROUP PTC EHF. AT UK/H/5290/001 H/13/00629/001 ACTAVIS GROUP PTC EHF. SI NL/H/0715/ /14 CHEMIPHARM S.G. DE TCHAVES & CIE E.E GR EMA/223740/2018 Page 17/18

18 FLUDARABINE EBEWE 25 mg/ml, solution à diluer injectable ou pour perfusion FLUDARABINE EBEWE 25 mg/ml, solution à diluer injectable ou pour perfusion FLUDARABINE EBEWE 25 mg/ml, solution à diluer injectable ou pour perfusion Fludarabine 25 mg/ml - concentrate for solution for injection or infusion Fludarabin HEXAL 25 mg/ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösung not available SANDOZ FR not available SANDOZ FR not available SANDOZ FR DE/H/0801/001 PL 14510/ EBEWE PHARMA UK not available HEXAL AG DE EMA/223740/2018 Page 18/18