Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2020 to 31 July 2020 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2020-08-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2020285EN.01001101.xml










28.8.2020   


EN


Official Journal of the European Union


C 285/11






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2020 to 31 July 2020
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2020/C 285/02)
—   Issuing, maintenance or modification of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




7.7.2020


fluorouracil and related substances (capecitabine, tegafur and flucytosine)


fluorouracil or fluorouracil and related substances (capecitabine, tegafur and flucytosine)


See Annex


See Annex


7.7.2020






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




ANNEX
List of nationally authorised medicinal products










Member State EU/EEA


Marketing authorisation holder


Invented name


INN + Strength


Pharmaceutical form


Route of administration




Austria


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Austria


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Austria


Almirall Hermal Gmbh


Verrumal


Fluorouracil 5mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Austria


Ebewe Pharma


5-Fluorouracil Ebewe


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intravenous use




Austria


Fairmed Healthcare Gmbh


Capecitabin Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Austria


Fairmed Healthcare Gmbh


Capecitabin Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Austria


G.L. Pharma Gmbh


Capecel


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Austria


G.L. Pharma Gmbh


Capecel


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Austria


Hikma Farmacêutica (Portugal), S.A.


Capecitabin Hikma


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Austria


Hikma Farmacêutica (Portugal), S.A.


Capecitabin Hikma


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Austria


Meda Pharma Gmbh


Ancotil


Flucytosine 2,5  g/250 ml


Solution for infusion


Intravenous use




Austria


Sandoz Gmbh


Capecitabin Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Austria


Sandoz Gmbh


Capecitabin Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Austria


Stada Arzneimittel Gmbh


Capecitabin Stada


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Austria


Stada Arzneimittel Gmbh


Capecitabin Stada


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Belgium


Accord Healthcare B.V.


Fluorouracil Accord Healthcare


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Belgium


Accord Healthcare B.V.


Fluorouracil Accord Healthcare


Fluorouracil 2 500  mg/50 ml


Solution for injection/infusion


Intravenous use




Belgium


Accord Healthcare B.V.


Fluorouracil Accord Healthcare


Fluorouracil 250 mg/ml


Solution for injection/infusion


Intravenous use




Belgium


Accord Healthcare B.V.


Fluorouracil Accord Healthcare


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Belgium


Accord Healthcare B.V.


Fluorouracil Accord Healthcare


Fluorouracil 500 mg/10 ml


Solution for injection/infusion


Intravenous use




Belgium


Actavis Group Ptc Ehf.


Capecitabine Actavis


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Belgium


Actavis Group Ptc Ehf.


Capecitabine Actavis


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Belgium


Cipla (Uk) Limited


Xelcip


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Belgium


Cipla (Uk) Limited


Xelcip


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Belgium


Eurogenerics N.V./S.A.


Capecitabine Eg


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Belgium


Eurogenerics N.V./S.A.


Capecitabine Eg


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Belgium


Fairmed Healthcare Gmbh


Capécitabine Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Belgium


Fairmed Healthcare Gmbh


Capécitabine Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Belgium


S.A. Meda Pharma N.V.


Efudix


Fluorouracil 5 g/100 g


Ointment


Cutaneous use




Belgium


Sandoz N.V.


Capecitabin Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Belgium


Sandoz N.V.


Capecitabin Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Belgium


Teva Pharma Belgium N.V./S.A


Fluracedyl


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intraarterial use/intravenous Use




Bulgaria


Accord Healthcare Limited


Флуороурацил Акорд


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intraarterial use/intravenous Use




Bulgaria


Alvogen Ipco S.Ar.L


Ксалвобин


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Bulgaria


Ebewe Pharma


5-Флуороурацил ‘ебеве’


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intravenous use




Bulgaria


Egis Pharmaceuticals Plc


Колоксет


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Bulgaria


Egis Pharmaceuticals Plc


Колоксет


Capecitabine 300 mg Tablet


Film-coated tablet


Oral use




Bulgaria


Egis Pharmaceuticals Plc


Колоксет


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Bulgaria


Fairmed Healthcare Gmbh


Kапецитабин Феър-Мед


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Bulgaria


Fairmed Healthcare Gmbh


Kапецитабин Феър-Мед


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Bulgaria


Meda Pharma Gmbh & Co. Kg


Ефудикс


Fluorouracil 50mgg


Cream


Cutaneous use




Croatia


Alpha-Medical D.O.O.


Kapetral


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Croatia


Alpha-Medical D.O.O.


Kapetral


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Croatia


Alvogen Malta Operations (Row) Ltd


Xalvobin


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Croatia


Jadran-Galenski Laboratorij D.D.


Kapecitabin Jgl


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Croatia


Jadran-Galenski Laboratorij D.D.


Kapecitabin Jgl


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Croatia


Krka-Farma D.O.O.


Cansata


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Croatia


Krka-Farma D.O.O.


Cansata


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Croatia


Mibe Pharmaceuticals D.O.O.


Verrucutan


Fluorouracil 5mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Croatia


Pliva Hrvatska D.O.O.


Fluorouracil Pliva


Fluorouracil 50 mg/Ml


Injection


Intravenous use




Croatia


Pliva Hrvatska D.O.O.


Fluorouracil Pliva


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Croatia


Sandoz D.O.O.


Fluorouracil Sandoz


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intravenous use




Croatia


Sandoz D.O.O.


Kapecitabin Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Cyprus


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Cyprus


Remedica Ltd


Capecitabine Remedica


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Cyprus


Remedica Ltd


Capecitabine Remedica


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Cyprus


Remedica Ltd


Kapetral


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Cyprus


Remedica Ltd


Kapetral


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Cyprus


Sandoz Gmbh


Capecitabin Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Cyprus


Sandoz Gmbh


Capecitabin Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Cyprus


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Cyprus


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Czech Republic


Accord Healthcare Polska Sp. Z O.O.


Fluorouracil Accord


Fluorouracil 250 mg/5 ml


Solution for injection/infusion


Intravenous use




Czech Republic


Accord Healthcare Polska Sp. Z O.O.


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Czech Republic


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Czech Republic


Almirall Hermal Gmbh


Verrumal


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Czech Republic


Ebewe Pharma


5-Fluorouracil Ebewe


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intraarterial use/intraperitoneal use/intrapleural use/intravenous Use




Czech Republic


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Czech Republic


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Czech Republic


Fairmed Healthcare Gmbh


Capecitabin Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Czech Republic


Fairmed Healthcare Gmbh


Capecitabin Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Czech Republic


Glenmark Pharmaceuticals S.R.O.


Capecitabine Glenmark


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Czech Republic


Glenmark Pharmaceuticals S.R.O.


Capecitabine Glenmark


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Czech Republic


Grindeks


Ftorafur


Tegafur 400 mg Capsule


Capsule, hard


Oral use




Czech Republic


Mylan Ireland Limited


Capecitabine Mylan


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Czech Republic


Mylan Ireland Limited


Capecitabine Mylan


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Czech Republic


Pharmagen Cz S.R.O.


Capecitabine


Capecitabine 500 mg Tablet


Coated tablet


Oral use




Czech Republic


Pharmagen Cz S.R.O.


Capecitabine Pharmagen


Capecitabine 150 mg Tablet


Coated tablet


Oral use




Denmark


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Denmark


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 2 500  mg/50 ml


Solution for injection/infusion


Intravenous use




Denmark


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 250 mg/5 ml


Solution for injection/infusion


Intravenous use




Denmark


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Denmark


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 500 mg/10 ml


Solution for injection/infusion


Intravenous use




Denmark


Actavis Group Ptc Ehf.


Capecitabin Actavis


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Denmark


Actavis Group Ptc Ehf.


Capecitabin Actavis


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Denmark


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Denmark


Fairmed Healthcare Gmbh


Capecitabin ‘fair-Med’


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Denmark


Fairmed Healthcare Gmbh


Capecitabin ‘fair-Med’


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Denmark


Fresenius Kabi Ab


Capecitabine Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Denmark


Fresenius Kabi Ab


Capecitabine Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Denmark


Orion Corporation


Capecitabine Orion


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Denmark


Orion Corporation


Capecitabine Orion


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Denmark


Pfizer Aps


Fluorouracil ‘pfizer’


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Denmark


Pfizer Aps


Flurablastin


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Denmark


Sandoz A/S


Capecitabine Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Denmark


Sandoz A/S


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Denmark


Stada Arzneimittel Ag


Capecitabin Stada


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Denmark


Stada Arzneimittel Ag


Capecitabin Stada


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Denmark


Teva B.V


Fluorouracil Teva


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Estonia


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Estonia


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 2 500  mg/50 ml


Solution for injection/infusion


Intravenous use




Estonia


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 250 mg/5 ml


Solution for injection/infusion


Intravenous use




Estonia


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Estonia


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 500 mg/10 ml


Solution for injection/infusion


Intravenous use




Estonia


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Estonia


Norameda Uab


Capecitabine Norameda


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Estonia


Norameda Uab


Capecitabine Norameda


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Estonia


Sandoz Pharmaceuticals D.D.


5-Fluorouracil Ebewe


Fluorouracil 500 mg/Ml


Concentrate for solution for injection/infusion


Intravenous use




Estonia


Sandoz Pharmaceuticals D.D.


Capecitabine Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Estonia


Sandoz Pharmaceuticals D.D.


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Estonia


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Estonia


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Finland


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Finland


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 2 500  mg/50 ml


Solution for injection/infusion


Intravenous use




Finland


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 250 mg/5 ml


Solution for injection/infusion


Intravenous use




Finland


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Finland


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 500 mg/10 ml


Solution for injection/infusion


Intravenous use




Finland


Actavis Group Ptc Ehf.


Capecitabin Actavis


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Finland


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Finland


Fairmed Healthcare Gmbh


Capecitabin Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Finland


Fairmed Healthcare Gmbh


Capecitabin Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Finland


Orion Oyj


Capecitabine Orion


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Finland


Orion Oyj


Capecitabine Orion


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




France


Accord Healthcare France Sas


Fluorouracile Accord


Fluorouracil 1 000  mg/20 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Accord Healthcare France Sas


Fluorouracile Accord


Fluorouracil 2 500  mg/50 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Accord Healthcare France Sas


Fluorouracile Accord


Fluorouracil 250 mg/5 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Accord Healthcare France Sas


Fluorouracile Accord


Fluorouracil 5 000  mg/100 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Accord Healthcare France Sas


Fluorouracile Accord


Fluorouracil 500 mg/10 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Arrow Generiques


Capecitabine Arrow


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




France


Arrow Generiques


Capecitabine Arrow


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




France


Biogaran


Capecitabine Biogaran


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




France


Biogaran


Capecitabine Biogaran


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




France


Cristers


Capecitabine Cristers


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




France


Cristers


Capecitabine Cristers


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




France


Dr Reddy’s Laboratories (Uk) Ltd.


Capecitabine Reddy


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




France


Eg Labo Laboratoires Eurogenerics


Capecitabine Eg


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




France


Eg Labo Laboratoires Eurogenerics


Capecitabine Eg


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




France


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




France


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




France


Meda Pharma Sas


Efudix


Fluorouracil 5 g/100 g


Cream


Cutaneous use




France


Meda Pharma Sas


Ancotil


Flucytosine 1 g/100 ml


Solution for infusion


Intravenous use




France


Meda Pharma Sas


Ancotil


Flucytosine 500 mg Tablet


Tablet


Oral use




France


Mylan S.A.S


Capecitabine Mylan


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




France


Mylan S.A.S


Capecitabine Mylan


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




France


Pfizer Holding France


Fluorouracile Pfizer


Fluorouracil 10 g/200 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Pfizer Holding France


Fluorouracile Pfizer


Fluorouracil 1 g/20 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Pfizer Holding France


Fluorouracile Pfizer


Fluorouracil 250 mg/5 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Pfizer Holding France


Fluorouracile Pfizer


Fluorouracil 500 mg/10 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Pfizer Holding France


Fluorouracile Pfizer


Fluorouracil 5 g/100 ml


Concentrate for solution for infusion


Intraarterial use/intravenous Use




France


Sandoz


Capecitabine Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




France


Sandoz


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




France


Teva Santé


Fluorouracile Teva


Fluorouracil 1 000  mg/20 ml


Injection


Intravenous use




France


Teva Santé


Fluorouracile Teva


Fluorouracil 250 mg/5ml


Injection


Intravenous use




France


Teva Santé


Fluorouracile Teva


Fluorouracil 5 000  mg/100 ml


Injection


Intravenous use




France


Teva Santé


Fluorouracile Teva


Fluorouracil 500 mg/10 ml


Solution for injection


Intravenous use




France


Zentiva France


Capecitabine Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




France


Zentiva France


Capecitabine Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Germany


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Germany


Aliud Pharma Gmbh


Capecitabin Al


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Germany


Aliud Pharma Gmbh


Capecitabin Al


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Germany


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Germany


Almirall Hermal Gmbh


Verrumal


Fluorouracil 0,5  g/100 g, Salicylic Acid 10 g/100 g


Cutaneous solution


Cutaneous use




Germany


Amneal Pharma Europe Limited


Fluorouracil Amneal


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Aqvida Gmbh


5-Fu Liv Pharma


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Bendalis Gmbh


Benda-5 Fu


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Betapharm Arzneimittel Gmbh


Capecitabin Beta


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Germany


Betapharm Arzneimittel Gmbh


Capecitabin Beta


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Germany


Bhardwaj Gmbh


Fluorouracil Bhardwaj


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Dermapharm Ag


Verrucutan


Fluorouracil 5mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Germany


Fairmed Healthcare Gmbh


Capecitabin Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Germany


Fairmed Healthcare Gmbh


Capecitabin Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Germany


Hexal Ag


Fluorouracil Hexal


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Germany


Hexal Ag


Capecitabin Hexal


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Germany


Hexal Ag


Capecitabin Hexal


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Germany


Hikma Farmacêutica (Portugal), S.A.


5-Fluorouracil Hikma Farmacêutica (Portugal)


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Hikma Farmacêutica (Portugal), S.A.


Ribofluor


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Hikma Farmacêutica (Portugal), S.A.


Capecitabin Ribosepharm


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Germany


Hikma Farmacêutica (Portugal), S.A.


Capecitabin Ribosepharm


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Germany


Meda Pharma Gmbh & Co. Kg


Efudix


Fluorouracil 50mgg


Cream


Cutaneous use




Germany


Meda Pharma Gmbh & Co. Kg


Ancotil


Flucytosine 2,5  g/250 ml


Solution for infusion


Intravenous use




Germany


Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)


5-Fu Medac


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Onkovis Gmbh


5-Fu Onkovis


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Onkovis Gmbh


Capecitabin Onkovis


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Germany


Onkovis Gmbh


Capecitabin Onkovis


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Germany


Pharma Resources Gmbh


Fluorouracil Phares


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Stadapharm Gmbh


5 Fu


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Stadapharm Gmbh


Capecitabin Cell Pharm


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Germany


Stadapharm Gmbh


Capecitabin Cell Pharm


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Germany


Temmler Pharma Gmbh


Fluorouracil Temmler


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Teva Gmbh


Fluorouracil Gry


Fluorouracil 250 mg/5 ml


Solution for injection


Intravenous use




Germany


Tillomed Pharma Gmbh


Fluorouracil Tillomed


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Vitane Pharma Gmbh


Fluorouracil Vitane


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Germany


Wave Pharma Limited


Capecitabin Waverley


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Germany


Wave Pharma Limited


Capecitabin Waverly


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Germany


Zentiva Pharma Gmbh


Capecitabin Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Germany


Zentiva Pharma Gmbh


Capecitabin Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Greece


Anabiosis Pc


Fluorouracil Anabiosis


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Greece


Anabiosis Pc


Zerectum


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Greece


Anabiosis Pc


Zerectum


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Greece


Ariti Sa


Capibine


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Greece


Ariti Sa


Capibine


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Greece


Medicus A.E


Uraciflor


Fluorouracil 250 mg/5 ml


Solution for injection


Intraarticular use/intraperitoneal use/intravenous use




Greece


Medicus A.E


Uraciflor


Fluorouracil 500 mg/10 ml


Solution for injection


Intraarticular use/intraperitoneal use/intravenous use




Greece


Mylan S.A.S


Capecitabine Mylan


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Greece


Mylan S.A.S


Capecitabine Mylan


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Greece


Olvos Science S.A.


Verruca Hermal


Fluorouracil 4,74  mg/Ml, Salicylic Acid 94,8  mg/Ml


Cutaneous solution


Cutaneous use




Greece


Opus-Materia Ltd


Fluorouracil Opus


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Greece


Pharmazac Sa


Preveloda


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Greece


Pharmazac Sa


Preveloda


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Greece


Sandoz Gmbh


Capecitabine Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Greece


Sandoz Gmbh


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Greece


Verisfield (Uk) Ltd


Actiker


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Greece


Vocate Φαρμακευτικη Αε


Xelazor


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Greece


Vocate Φαρμακευτικη Αε


Xelazor


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Greece


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Greece


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Hungary


Accord Healthcare Polska Sp. Z O.O.


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Hungary


Almirall Hermal Gmbh


Verrumal


Fluorouracil 0,005  gg, Salicylic Acid 0,1  gg


Cutaneous solution


Cutaneous use




Hungary


Alvogen Ipco S.Ar.L


Xalvobin


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Hungary


Alvogen Ipco S.Ar.L


Xalvobin


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Hungary


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Hungary


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 300 mg Tablet


Film-coated tablet


Oral use




Hungary


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Hungary


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Hungary


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Hungary


Grindeks


Ftorafur


Tegafur 400 mg Capsule


Capsule, hard


Oral use




Hungary


Mylan Epd Kft.


Efudix


Fluorouracil 50 mgg


Ointment


Cutaneous use




Hungary


Sandoz Hungária Kft


5-Fluorouracil Ebewe


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intravenous use




Hungary


Sandoz Hungária Kft


Capecitabin Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Hungary


Sandoz Hungária Kft


Capecitabin Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Hungary


Teva Gyógyszergyár Zrt


Fluorouracil Teva


Fluorouracil 50 mg/Ml


Injection


Intravenous use




Hungary


Teva Gyógyszergyár Zrt


Fluorouracil Teva


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Hungary


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Hungary


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Iceland


Accord Healthcare B.V.


Flúoróúracíl Accord


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Iceland


Accord Healthcare B.V.


Flúoróúracíl Accord


Fluorouracil 2 500  mg/50 ml


Solution for injection/infusion


Intravenous use




Iceland


Accord Healthcare B.V.


Flúoróúracíl Accord


Fluorouracil 250 mg/5 ml


Solution for injection/infusion


Intravenous use




Iceland


Accord Healthcare B.V.


Flúoróúracíl Accord


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Iceland


Accord Healthcare B.V.


Flúoróúracíl Accord


Fluorouracil 500 mg/10 ml


Solution for injection/infusion


Intravenous use




Iceland


Actavis Group Ptc Ehf.


Capecitabin Actavis


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Iceland


Actavis Group Ptc Ehf.


Capecitabin Actavis


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Iceland


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Iceland


Fresenius Kabi Ab


Capecitabine Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Iceland


Fresenius Kabi Ab


Capecitabine Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Iceland


Pfizer Aps


Flurablastin


Fluorouracil 50 mg/Ml


Solution for injection


Intravenous use




Ireland


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Ireland


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 2 500  mg/50 ml


Solution for injection/infusion


Intravenous use




Ireland


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 250 mg/5 ml


Solution for injection/infusion


Intravenous use




Ireland


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Ireland


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 500 mg/10 ml


Solution for injection/infusion


Intravenous use




Ireland


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi Oncology


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Ireland


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi Oncology


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Ireland


Mylan Ire Healthcare Limited


Efudix


Fluorouracil 5 % w/W


Cream


Cutaneous use




Ireland


Mylan Ire Healthcare Limited


Ancotil


Flucytosine 2,5  g/250 ml


Solution for infusion


Intraperitoneal use/intravenous use




Ireland


Pfizer Healthcare Ireland


Fluorouracil Pfizer Healthcare Ireland


Fluorouracil 25 mg/Ml


Solution for injection/infusion


Intraarterial use/intravenous Use




Ireland


Rowex Ltd


Capecitabine Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Ireland


Rowex Ltd


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Italy


Accord Healthcare Limited


Fluorouracile Ahcl


Fluorouracil 500 mg/50 ml


Solution for injection/infusion


Intravenous use




Italy


Accord Healthcare Limited


Fluorouracile Ahcl


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Italy


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Italy


Dr Reddy’s Laboratories (Uk) Ltd.


Capecitabina Dr Reddy’s


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Italy


Fairmed Healthcare Gmbh


Capecitabina Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Italy


Fairmed Healthcare Gmbh


Capecitabina Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Italy


Hikma Farmacêutica (Portugal), S.A.


Fluorouracile Hikma


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Italy


Hikma Farmacêutica (Portugal), S.A.


Capecitabina Hikma


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Italy


Hikma Farmacêutica (Portugal), S.A.


Capecitabina Hikma


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Italy


Meda Pharma S.P.A.


Ancotil


Flucytosine 2,5  g/250 ml


Solution for infusion


Intravenous use




Italy


Mylan S.P.A.


Capecitabina Mylan


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Italy


Mylan S.P.A.


Capecitabina Mylan


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Italy


Teva Italia S.R.L.


Fl


Fluorouracil 50 mg/Ml


Injection


Intramuscular use/intravenous use




Italy


Teva Italia S.R.L.


Fluorouracil Teva


Fluorouracil 50 mg/Ml


Injection


Intramuscular use/intravenous use




Italy


Zentiva Italia Srl


Capecitabina Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Italy


Zentiva Italia Srl


Capecitabina Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Latvia


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Latvia


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Latvia


Grindeks


Ftorafur


Tegafur 400 mg Capsule


Capsule, hard


Oral use




Latvia


Norameda Uab


Capecitabine Norameda


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Latvia


Norameda Uab


Capecitabine Norameda


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Latvia


Sandoz Pharmaceuticals D.D.


Fluorouracil Ebewe


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intraarterial use/intravenous Use




Latvia


Sandoz Pharmaceuticals D.D.


Fluorouracil Ebewe


Fluorouracil 50 mg/Ml | Fluorouracil 50 ml/Ml


Concentrate for solution for injection/infusion


Intravenous use




Latvia


Sandoz Pharmaceuticals D.D.


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Latvia


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Latvia


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Lithuania


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Lithuania


Grindeks


Ftorafur


Tegafur 400 mg Capsule


Capsule, hard


Oral use




Lithuania


Norameda Uab


Capecitabine Norameda


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Lithuania


Norameda Uab


Capecitabine Norameda


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Lithuania


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Lithuania


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Luxembourg


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Luxembourg


Almirall Hermal Gmbh


Verrumal


Fluorouracil 0,5  g/100 g, Salicylic Acid 10 g/100 g


Cutaneous solution


Cutaneous use




Luxembourg


Eurogenerics N.V./S.A.


Capecitabine Eg


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Luxembourg


Eurogenerics N.V./S.A.


Capecitabine Eg


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Luxembourg


S.A. Meda Pharma N.V.


Efudix


Fluorouracil 5 g/100 g


Ointment


Cutaneous use




Luxembourg


Teva Pharma Belgium N.V./S.A


Fluracedyl


Fluorouracil 50 mg/Ml


Injection


Intravenous use




Malta


1 A Pharma Gmbh


Capecitabine Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Malta


1 A Pharma Gmbh


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Malta


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Malta


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 2 500  mg/50 ml


Solution for injection/infusion


Intravenous use




Malta


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 250 mg/5 ml


Solution for injection/infusion


Intravenous use




Malta


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Malta


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 500 mg/10 ml


Solution for injection/infusion


Intravenous use




Malta


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi Oncology


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Malta


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi Oncology


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Malta


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 1 g/20 ml


Solution for injection


Intraarterial use/intravenous Use




Malta


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 2,5  g/50 ml


Solution for injection


Intraarterial use/intravenous Use




Malta


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 500 mg/10 ml


Solution for injection


Intraarterial use/intravenous Use




Malta


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 5 g/100 ml


Solution for injection


Intraarterial use/intravenous Use




Malta


Meda Pharmaceuticals Limited


Efudix


Fluorouracil 5 % w/W


Cream


Cutaneous use




Netherlands


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Netherlands


Centrafarm B.V.


Capecitabine Cf


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Netherlands


Centrafarm B.V.


Capecitabine Cf


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Netherlands


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Netherlands


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 300 mg Tablet


Film-coated tablet


Oral use




Netherlands


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Netherlands


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Netherlands


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Netherlands


Fresenius Kabi Nederland B.V.


Capecitabine Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Netherlands


Fresenius Kabi Nederland B.V.


Capecitabine Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Netherlands


Intas Pharmaceuticals Limited


Capecitabine Astron


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Netherlands


Intas Pharmaceuticals Limited


Capecitabine Astron


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Netherlands


Mylan B.V.


Capecitabine Mylan


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Netherlands


Mylan B.V.


Capecitabine Mylan


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Netherlands


Mylan Healthcare B.V.


Efudix


Fluorouracil 50 mgg


Cream


Cutaneous use




Netherlands


Mylan Healthcare B.V.


Ancotil


Flucytosine 10 mg/Ml


Solution for infusion


Intravenous use




Netherlands


Sandoz B.V.


5-Fluorouracil Sandoz


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intravenous use




Netherlands


Sandoz B.V.


Capecitabine Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Netherlands


Sandoz B.V.


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Norway


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Norway


Accord Healthcare B.V.


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Norway


Actavis Group Ptc Ehf.


Capecitabine Actavis


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Norway


Actavis Group Ptc Ehf.


Capecitabine Actavis


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Norway


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Norway


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Norway


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Norway


Teva B.V


Fluorouracil Teva


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Poland


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Poland


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Poland


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Poland


Almirall Hermal Gmbh


Verrumal


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Poland


Alvogen Ipco S.Ar.L


Xalvobin


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Poland


Alvogen Ipco S.Ar.L


Xalvobin


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Poland


Ebewe Pharma


5-Fluorouracil Ebewe


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intraarterial use/intravenous Use




Poland


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Poland


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Poland


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Poland


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Poland


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Poland


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Poland


Glenmark Pharmaceuticals S.R.O.


Capecitabine Glenmark


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Poland


Glenmark Pharmaceuticals S.R.O.


Capecitabine Glenmark


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Poland


Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)


Fluorouracil Medac


Fluorouracil 50 mg/Ml


Solution for injection


Intraarterial use/intravenous Use




Poland


Mylan Healthcare Sp. Z.O.O.


Efudix


Fluorouracil 50mgg


Cream


Cutaneous use




Poland


Mylan S.A.S


Capecitalox


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Poland


Mylan S.A.S


Capecitalox


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Poland


Pharmaswiss Česká Republika S.R.O.


Ancotil


Flucytosine 10 mg/Ml


Solution for infusion


Intravenous use




Poland


Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Z O.O.


Capecitabine Lek-Am


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Poland


Sun-Farm Sp. Z.O.O.


Verrucutan


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Poland


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Poland


Zentiva, K.S.


Capecitabine Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Accord Healthcare Limited


Fluorouracilo Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Portugal


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Portugal


Almirall Hermal Gmbh


Verrumal


Fluorouracil 5 mg/Ml, Salicylic Acid 100 mg/Ml


Cutaneous solution


Cutaneous use




Portugal


Anabiosis Pc


Fluorouracilo Anabiosis


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Portugal


Anabiosis Pc


Zerectum


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Anabiosis Pc


Zerectum


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Farmoz — Sociedade Técnico Medicinal, S.A.


Capecitabina Farmoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Farmoz — Sociedade Técnico Medicinal, S.A.


Capecitabina Farmoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Fresenius Kabi Pharma Portugal, Lda.


Capecitabina Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Fresenius Kabi Pharma Portugal, Lda.


Capecitabina Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.


Capecitabina Aurovitas


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Generis Farmacêutica, S.A.


Capecitabina Aurovitas


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Hikma Farmacêutica (Portugal), S.A.


Fluorouracilo Hikma


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Portugal


Hikma Farmacêutica (Portugal), S.A.


Capecitabina Hikma


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Hikma Farmacêutica (Portugal), S.A.


Capecitabina Hikma


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Laboratório Medinfar — Produtos Farmacêuticos, S.A.


Verrucare


Fluorouracil 5 mg/Ml, Salicylic Acid 100 mg/Ml


Cutaneous solution


Cutaneous use




Portugal


Laboratórios Normon, S.A.


Capecitabina Normon


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Laboratórios Normon, S.A.


Capecitabina Normon


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Laboratórios Pfizer, Lda.


Cinkef-U


Fluorouracil 1 g/20 ml


Solution for injection


Intraarterial use/intravenous Use




Portugal


Laboratórios Pfizer, Lda.


Cinkef-U


Fluorouracil 2,5  g/50 ml


Solution for injection


Intraarterial use/intravenous Use




Portugal


Laboratórios Pfizer, Lda.


Cinkef-U


Fluorouracil 500 mg/10 ml


Solution for injection


Intraarterial use/intravenous Use




Portugal


Laboratórios Pfizer, Lda.


Cinkef-U


Fluorouracil 5 g/100 ml


Solution for injection


Intraarterial use/intravenous Use




Portugal


Labosuan I+d S.L.


Capecitabina Labosuan


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Labosuan I+d S.L.


Capecitabina Labosuan


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Opus-Materia Ltd


Fluorouracil Opus


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Portugal


Pharmacare Premium Limited


Capecitabina Bluelife


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Pharmacare Premium Limited


Capecitabina Bluelife


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Sandoz Farmacêutica Lda.


Capecitabina Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Sandoz Farmacêutica Lda.


Capecitabina Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Stada Lda.


Capecitabina Stada


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Stada Lda.


Capecitabina Stada


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Teva B.V


Fluorouracilo Refta


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Portugal


Teva Pharma — Produtos Farmacêuticos Lda


Fluorouracilo Teva


Fluorouracil 50 mg/Ml


Solution for injection


Intraarterial use/intravenous Use




Portugal


Teva Pharma — Produtos Farmacêuticos Lda


Fluorouracilo Teva


Fluorouracil 50 mg/Ml


Injection


Intravenous use




Portugal


Vocate Φαρμακευτικη Αε


Xelazor


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Vocate Φαρμακευτικη Αε


Xelazor


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Portugal


Zentiva Portugal, Lda


Capecitabina Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Portugal


Zentiva Portugal, Lda


Capecitabina Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Romania


Accord Healthcare Polska Sp. Z O.O.


Fluorouracil Accord


Fluorouracil 250 mg/5ml


Solution for injection/infusion


Intravenous use




Romania


Accord Healthcare Polska Sp. Z O.O.


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Romania


Alvogen Ipco S.Ar.L


Xalvobin


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Romania


Alvogen Ipco S.Ar.L


Xalvobin


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Romania


Dr Reddy’s Laboratories Romania Srl


Capecitabină Dr Reddy’s


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Romania


Ebewe Pharma


5-Fluorouracil


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intraarterial use/intraperitoneal use/intravenous use




Romania


Fairmed Healthcare Gmbh


Capecitabinä Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Romania


Fairmed Healthcare Gmbh


Capecitabinä Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Romania


Glenmark Pharmaceuticals S.R.O.


Capecitabină Glenmark


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Romania


Neola Pharma Srl


Arxeda


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Romania


Neola Pharma Srl


Arxeda


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Romania


S.C. Fresenius Kabi România S.R.L.


Capecitabina Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Romania


S.C. Fresenius Kabi România S.R.L.


Capecitabina Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Romania


Terapia S.A.


Cerex


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Slovakia


Accord Healthcare Polska Sp. Z O.O.


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




Slovakia


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Slovakia


Almirall Hermal Gmbh


Verrumal


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Slovakia


Ebewe Pharma


5-Fluorouracil Ebewe


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intraarterial use/intraperitoneal use/intravenous use




Slovakia


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Slovakia


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 300 mg Tablet


Film-coated tablet


Oral use




Slovakia


Egis Pharmaceuticals Plc


Coloxet


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Slovakia


Glenmark Pharmaceuticals S.R.O.


Capecitabine Glenmark


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Slovakia


Mylan Ire Healthcare Limited


Efudix


Fluorouracil 50 mgg


Ointment


Cutaneous use




Slovakia


Mylan Ireland Limited


Capecitalox


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Slovakia


Pharmagen Cz S.R.O.


Capecitabine Pharmagen


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Slovakia


Pharmagen Cz S.R.O.


Capecitabine Pharmagen


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Slovakia


Pharmevid S.R.O.


Capecitabine Pharmacenter


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Slovakia


Sandoz Pharmaceuticals D.D.


5-Fluorouracil Ebewe


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intraarterial use/intraperitoneal use/intrapleural use/intravenous Use




Slovakia


Stada Arzneimittel Ag


Capecitabine Stada


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Slovenia


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Slovenia


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 2 500  mg/50 ml


Solution for injection/infusion


Intravenous use




Slovenia


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 250 mg/5 ml


Solution for injection/infusion


Intravenous use




Slovenia


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Slovenia


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 500 mg/10 ml


Solution for injection/infusion


Intravenous use




Slovenia


Ebewe Pharma


5-Fluorouracil Ebewe


Fluorouracil 50 mg/Ml


Concentrate for solution for injection/infusion


Intravenous use




Slovenia


Fresenius Kabi Oncology Plc.


Kapecitabin Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Slovenia


Sandoz Pharmaceuticals D.D.


Kapecitabin Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Slovenia


Sandoz Pharmaceuticals D.D.


Kapecitabin Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Spain


Accord Healthcare S.L.U.


Fluorouracilo Accord


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Spain


Accord Healthcare S.L.U.


Fluorouracilo Accord


Fluorouracil 250 mg/5ml


Solution for injection/infusion


Intravenous use




Spain


Accord Healthcare S.L.U.


Fluorouracilo Accord


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Spain


Accord Healthcare S.L.U.


Fluorouracilo Accord


Fluorouracil 500 mg/10ml


Solution for injection/infusion


Intravenous use




Spain


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Spain


Aurovitas Spain, s.A.U.


Capecitabina Aurovitas Spain


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Spain


Aurovitas Spain, s.A.U.


Capecitabina Aurovitas Spain


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Spain


Cipla (Uk) Limited


Xelcip


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Spain


Cipla (Uk) Limited


Xelcip


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Spain


Fairmed Healthcare Gmbh


Capecitabina Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Spain


Fairmed Healthcare Gmbh


Capecitabina Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Spain


Fresenius Kabi Oncology Plc.


Capecitabina Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Spain


Fresenius Kabi Oncology Plc.


Capecitabina Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Spain


Kern Pharma, S.L.


Capecitabina Kern Pharma


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Spain


Kern Pharma, S.L.


Capecitabina Kern Pharma


Capecitabine 300 mg Tablet


Film-coated tablet


Oral use




Spain


Kern Pharma, S.L.


Capecitabina Kern Pharma


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Spain


Laboratorios Normon, S.A.


Capecitabina Normon


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Spain


Laboratorios Normon, S.A.


Capecitabina Normon


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Spain


Mylan Pharmaceuticals S.L.


Utefos


Tegafur 400 mg Capsule


Capsule, hard


Oral use




Spain


Reddy Pharma Iberia, S.A.


Capecitabina Dr Reddys


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Spain


Sandoz Farmacéutica, S.A.


Capecitabina Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Spain


Sandoz Farmacéutica, S.A.


Capecitabina Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Spain


Zaphyr Pharmaceuticals Ireland Limited


Zapecine


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Spain


Zaphyr Pharmaceuticals Ireland Limited


Zapecine


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Sweden


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 1 000  mg/20 ml


Solution for injection/infusion


Intravenous use




Sweden


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 2 500  mg/50 ml


Solution for injection/infusion


Intravenous use




Sweden


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 250 mg/5 ml


Solution for injection/infusion


Intravenous use




Sweden


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 5 000  mg/100 ml


Solution for injection/infusion


Intravenous use




Sweden


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 500 mg/10 ml


Solution for injection/infusion


Intravenous use




Sweden


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




Sweden


Alvogen Ipco S.Ar.L


Xalvobin


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Sweden


Alvogen Ipco S.Ar.L


Xalvobin


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Sweden


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Sweden


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Sweden


Fresenius Kabi Oncology Plc.


Capecitabin Fresenius Kabi


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Sweden


Fresenius Kabi Oncology Plc.


Capecitabin Fresenius Kabi


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Sweden


Meda Ab


Ancotil


Flucytosine 10 mg/Ml


Solution for infusion


Intravenous use




Sweden


Mylan Ab


Capecitalox


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Sweden


Mylan Ab


Capecitalox


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Sweden


Orion Corporation


Capecitabine Orion


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Sweden


Orion Corporation


Capecitabine Orion


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Sweden


Sandoz A/S


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Sweden


Stada Arzneimittel Ag


Capecitabin Stada


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




Sweden


Stada Arzneimittel Ag


Capecitabin Stada


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




Sweden


Teva Sweden Ab


Fluorouracil Teva


Fluorouracil 50 mg/Ml


Injection


Intravenous use




United Kingdom


Accord Healthcare Limited


Fluorouracil Accord


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




United Kingdom


Accord Healthcare Limited


Fluorouracil Accord Healthcare


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




United Kingdom


Actavis Uk Ltd.


Capecitabine Accord-Uk


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Actavis Uk Ltd.


Capecitabine Accord-Uk


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Almirall Hermal Gmbh


Actikerall


Fluorouracil 5 mgg, Salicylic Acid 100 mgg


Cutaneous solution


Cutaneous use




United Kingdom


Cipla (Eu) Limited


Xelcip


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Cipla (Eu) Limited


Xelcip


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (Uk) Ltd.


Capecitabine Dr Reddy’s


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Dr Reddy’s Laboratories (Uk) Ltd.


Capecitabine Dr Reddy’s


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Fairmed Healthcare Gmbh


Capecitabine Fair-Med


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi Oncology


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Fresenius Kabi Oncology Plc.


Capecitabine Fresenius Kabi Oncology


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Generics [uk] Limited


Capecitabine Mylan


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Generics [uk] Limited


Capecitabine Mylan


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Glenmark Pharmaceuticals Europe Limited


Capecitabine Glenmark Pharmaceuticals Europe


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Glenmark Pharmaceuticals Europe Limited


Capecitabine Glenmark Pharmaceuticals Europe


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Hikma Farmacêutica (Portugal), S.A.


Fluorouracil Hikma Farmacêutica Portugal


Fluorouracil 50 mg/Ml


Solution for injection/infusion


Intravenous use




United Kingdom


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 1 g/20 ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 2,5  g/100 ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 2,5  g/50 ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 250 mg/10 ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 250 mg/5 ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 500 mg/10 ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 500 mg/20 ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Hospira Uk Ltd


Fluorouracil Hospira Uk


Fluorouracil 5 g/100 ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)


Fluorouracil Medac


Fluorouracil 25 mg/Ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)


Fluorouracil Medac


Fluorouracil 50 mg/Ml


Solution for injection


Intraarterial use/intravenous Use




United Kingdom


Morningside Healthcare Ltd


Capecitabine Morningside Healthcare


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Morningside Healthcare Ltd


Capecitabine Morningside Healthcare


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Mylan Products Limited


Efudix


Fluorouracil 5 % w/W


Cream


Cutaneous use




United Kingdom


Mylan Products Limited


Ancotil


Flucytosine 2,5  g Bottle


Solution for infusion


Intraperitoneal use/intravenous use




United Kingdom


Sandoz Ltd


Capecitabine Sandoz


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Sandoz Ltd


Capecitabine Sandoz


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Wave Pharma Limited


Capecitabine Reliance


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Wave Pharma Limited


Capecitabine Reliance


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Zentiva Pharma Uk Limited


Capecitabine Zentiva


Capecitabine 150 mg Tablet


Film-coated tablet


Oral use




United Kingdom


Zentiva Pharma Uk Limited


Capecitabine Zentiva


Capecitabine 500 mg Tablet


Film-coated tablet


Oral use