# Official Journal C 285/28 A

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 285 |
| | |
| English edition | Information and Notices | Volume 6328 August 2020 |

ISSN 1977-091X

Official Journal

of the European Union

C 285

English edition

Information and Notices

Volume 6328 August 2020

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2020/C 285/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2020 to 31 July 2020(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2020/C 285/02 | 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) | 11 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2020/C 285/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2020 to 31 July 2020(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2020/C 285/02

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)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

11

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.8.2020 | EN | Official Journal of the European Union | C 285/1 |
| --- | --- | --- | --- |

28.8.2020

EN

Official Journal of the European Union

C 285/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2020 to 31 July 2020

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2020/C 285/01)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.7.2020 | Mvabea | Ebola vaccine (MVA-BN-Filo [recombinant]) | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/20/1445 | Suspension for injection | J07BX02 | 6.7.2020 |
| 1.7.2020 | Zabdeno | Ebola vaccine (Ad26.ZEBOV-GP [recombinant]) | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/20/1444 | Suspension for injection | J07BX02 | 6.7.2020 |
| 3.7.2020 | Enerzair Breezhaler | indacaterol/glycopyrronium/mometasone furoate | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/20/1438 | Inhalation powder, hard capsule | R03AL12 | 6.7.2020 |
| 3.7.2020 | Veklury | remdesivir | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/20/1459 | Concentrate for solution for infusion
  Powder for concentrate for solution for infusion | Pending | 3.7.2020 |
| 3.7.2020 | Zimbus Breezhaler | indacaterol/glycopyrronium/mometasone furoate | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/20/1440 | Inhalation powder, hard capsule | R03AL12 | 6.7.2020 |
| 23.7.2020 | Apixaban Accord | apixaban | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/20/1458 | Film-coated tablet | B01AF02 | 27.7.2020 |
| 27.7.2020 | Piqray | alpelisib | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/20/1455 | Film-coated tablet | L01XX65 | 28.7.2020 |
| 27.7.2020 | Xenleta | lefamulin | Nabriva Therapeutics Ireland DAC
  Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland | EU/1/20/1457 | Film-coated tablet | J01XX12 | 28.7.2020 |
| 27.7.2020 | Zercepac | trastuzumab | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/20/1456 | Powder for concentrate for solution for infusion | L01XC03 | 28.7.2020 |
| 31.7.2020 | Hepcludex | bulevirtide | Myr GmbH
  Hessenring 89, 61348 Bad Homburg, Deutschland | EU/1/20/1446 | Powder for solution for injection | J05AX28 | 5.8.2020 |
| 31.7.2020 | Pretomanid FGK | pretomanid | FGK Representative Service GmbH
  Heimeranstraße 35, 80339 München, Deutschland | EU/1/20/1437 | Tablet | Pending | 4.8.2020 |
| 31.7.2020 | Rozlytrek | entrectinib | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/20/1460 | Capsule, hard | L01XE56 | 3.8.2020 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

1.7.2020

Mvabea

Ebola vaccine (MVA-BN-Filo [recombinant])

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1445

Suspension for injection

J07BX02

6.7.2020

1.7.2020

Zabdeno

Ebola vaccine (Ad26.ZEBOV-GP [recombinant])

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1444

Suspension for injection

J07BX02

6.7.2020

3.7.2020

Enerzair Breezhaler

indacaterol/glycopyrronium/mometasone furoate

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/20/1438

Inhalation powder, hard capsule

R03AL12

6.7.2020

3.7.2020

Veklury

remdesivir

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

Concentrate for solution for infusion

Powder for concentrate for solution for infusion

Pending

3.7.2020

3.7.2020

Zimbus Breezhaler

indacaterol/glycopyrronium/mometasone furoate

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/20/1440

Inhalation powder, hard capsule

R03AL12

6.7.2020

23.7.2020

Apixaban Accord

apixaban

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/20/1458

Film-coated tablet

B01AF02

27.7.2020

27.7.2020

Piqray

alpelisib

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/20/1455

Film-coated tablet

L01XX65

28.7.2020

27.7.2020

Xenleta

lefamulin

Nabriva Therapeutics Ireland DAC

Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland

EU/1/20/1457

Film-coated tablet

J01XX12

28.7.2020

27.7.2020

Zercepac

trastuzumab

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/20/1456

Powder for concentrate for solution for infusion

L01XC03

28.7.2020

31.7.2020

Hepcludex

bulevirtide

Myr GmbH

Hessenring 89, 61348 Bad Homburg, Deutschland

EU/1/20/1446

Powder for solution for injection

J05AX28

5.8.2020

31.7.2020

Pretomanid FGK

pretomanid

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/20/1437

Tablet

Pending

4.8.2020

31.7.2020

Rozlytrek

entrectinib

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/20/1460

Capsule, hard

L01XE56

3.8.2020

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.7.2020 | Hopveus | D&A PHARMA
  18 Rue Saint Matthieu, 78550 Houdan, France | — | 8.7.2020 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.7.2020

Hopveus

D&A PHARMA

18 Rue Saint Matthieu, 78550 Houdan, France

—

8.7.2020

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.7.2020 | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/13/891 | 7.7.2020 |
| 3.7.2020 | Capecitabine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/12/762 | 6.7.2020 |
| 3.7.2020 | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 6.7.2020 |
| 3.7.2020 | Ecansya | KRKA d d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/12/763 | 6.7.2020 |
| 3.7.2020 | Exforge | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/370 | 6.7.2020 |
| 3.7.2020 | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 7.7.2020 |
| 3.7.2020 | Hetlioz | Vanda Pharmaceuticals Germany GmbH
  Französische Str. 12, c/o Satellite Office, 10117 Berlin, Deutschland | EU/1/15/1008 | 6.7.2020 |
| 3.7.2020 | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 6.7.2020 |
| 3.7.2020 | Insulatard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/233 | 6.7.2020 |
| 3.7.2020 | Lemtrada | Sanofi Belgium
  Leonardo Da Vincilaan 19, B-1831 Diegem, België | EU/1/13/869 | 13.7.2020 |
| 3.7.2020 | Lynparza | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/959 | 7.7.2020 |
| 3.7.2020 | Mixtard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/231 | 6.7.2020 |
| 3.7.2020 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 7.7.2020 |
| 3.7.2020 | Pregabalin Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1027 | 7.7.2020 |
| 3.7.2020 | PREVYMIS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/17/1245 | 7.7.2020 |
| 3.7.2020 | Protaphane | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/234 | 6.7.2020 |
| 3.7.2020 | Suboxone | Indivior Europe Limited
  27 Windsor Place, Dublin 2, Ireland | EU/1/06/359 | 6.7.2020 |
| 3.7.2020 | Teysuno | Nordic Group B.V.
  Siriusdreef 41, 2132 WT Hoofddorp, Nederland | EU/1/11/669 | 7.7.2020 |
| 3.7.2020 | Xeloda | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/163 | 6.7.2020 |
| 6.7.2020 | Capecitabine medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/12/802 | 7.7.2020 |
| 6.7.2020 | Kolbam | Retrophin Europe Limited
  Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/13/895 | 17.7.2020 |
| 6.7.2020 | Picato | LEO Laboratories Ltd
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 8.7.2020 |
| 13.7.2020 | Aripiprazole Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1045 | 15.7.2020 |
| 13.7.2020 | BiResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/921 | 16.7.2020 |
| 13.7.2020 | DuoResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/920 | 16.7.2020 |
| 13.7.2020 | Kisqali | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1221 | 15.7.2020 |
| 13.7.2020 | Lonquex | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/13/856 | 16.7.2020 |
| 13.7.2020 | Mulpleo | Shionogi B.V.
  Kingsfordweg 151, 1043 GR Amsterdam, Nederland | EU/1/18/1348 | 17.7.2020 |
| 13.7.2020 | Namuscla | Lupin Europe GmbH
  Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland | EU/1/18/1325 | 15.7.2020 |
| 13.7.2020 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 15.7.2020 |
| 13.7.2020 | Tracleer | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/02/220 | 14.7.2020 |
| 16.7.2020 | Capecitabine medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/12/802 | 22.7.2020 |
| 16.7.2020 | Dukoral | Valneva Sweden AB
  105 21 Stockholm, Sverige | EU/1/03/263 | 23.7.2020 |
| 16.7.2020 | Toviaz | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/386 | 17.7.2020 |
| 17.7.2020 | Capecitabine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/12/762 | 23.7.2020 |
| 17.7.2020 | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 21.7.2020 |
| 17.7.2020 | Filgrastim Hexal | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/08/496 | 23.7.2020 |
| 17.7.2020 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 22.7.2020 |
| 17.7.2020 | Imlygic | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1064 | 27.7.2020 |
| 17.7.2020 | Silodyx | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/607 | 27.7.2020 |
| 17.7.2020 | Vihuma | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/16/1168 | 30.7.2020 |
| 23.7.2020 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 27.7.2020 |
| 23.7.2020 | Bavencio | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1214 | 27.7.2020 |
| 23.7.2020 | Besponsa | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1200 | 24.7.2020 |
| 23.7.2020 | Ciambra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Luxembourg | EU/1/15/1055 | 27.7.2020 |
| 23.7.2020 | Dectova | GlaxoSmithKline Trading Services Limited
  Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland | EU/1/18/1349 | 28.7.2020 |
| 23.7.2020 | Emtricitabine/Tenofovir disoproxil Krka | KRKA d d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/16/1151 | 30.7.2020 |
| 23.7.2020 | Nordimet | Nordic Group B.V.
  Siriusdreef 41, 2132 WT Hoofddorp, Nederland | EU/1/16/1124 | 28.7.2020 |
| 23.7.2020 | Omidria | Omeros Ireland Limited
  Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, Ireland | EU/1/15/1018 | 27.7.2020 |
| 23.7.2020 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 24.7.2020 |
| 23.7.2020 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 24.7.2020 |
| 23.7.2020 | Votubia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/710 | 24.7.2020 |
| 23.7.2020 | VPRIV | Shire Pharmaceuticals Ireland Limited
  Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland | EU/1/10/646 | 24.7.2020 |
| 24.7.2020 | Remsima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/13/853 | 27.7.2020 |
| 27.7.2020 | APTIVUS | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/05/315 | 28.7.2020 |
| 27.7.2020 | Buccolam | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/709 | 29.7.2020 |
| 27.7.2020 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 5.8.2020 |
| 27.7.2020 | Duzallo | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/18/1300 | 28.7.2020 |
| 27.7.2020 | Flucelvax Tetra | Seqirus Netherlands B.V.
  Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands | EU/1/18/1326 | 29.7.2020 |
| 27.7.2020 | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/887 | 6.8.2020 |
| 27.7.2020 | Iclusig | Incyte Biosciences Distribution B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/13/839 | 4.8.2020 |
| 27.7.2020 | Imfinzi | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/18/1322 | 29.7.2020 |
| 27.7.2020 | Nerlynx | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | EU/1/18/1311 | 28.7.2020 |
| 27.7.2020 | Nuwiq | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/14/936 | 4.8.2020 |
| 27.7.2020 | Orphacol | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | EU/1/13/870 | 29.7.2020 |
| 27.7.2020 | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | 28.7.2020 |
| 27.7.2020 | Rilutek | Sanofi Mature IP
  54 rue La Boétie, 75008, Paris, France | EU/1/96/010 | 28.7.2020 |
| 27.7.2020 | Votrient | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/628 | 28.7.2020 |
| 31.7.2020 | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 4.8.2020 |
| 31.7.2020 | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 4.8.2020 |
| 31.7.2020 | Evista | SUBSTIPHARM
  24 rue Erlanger, 75016 Paris, France | EU/1/98/073 | 4.8.2020 |
| 31.7.2020 | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 4.8.2020 |
| 31.7.2020 | LIBTAYO | Regeneron Ireland Designated Activity Company (DAC)
  Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland | EU/1/19/1376 | 4.8.2020 |
| 31.7.2020 | Olanzapine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/427 | 3.8.2020 |
| 31.7.2020 | Qutenza | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/09/524 | 4.8.2020 |
| 31.7.2020 | Retacrit | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/431 | 4.8.2020 |
| 31.7.2020 | Ruxience | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/20/1431 | 4.8.2020 |
| 31.7.2020 | Xolair | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/319 | 4.8.2020 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.7.2020

Brintellix

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/13/891

7.7.2020

3.7.2020

Capecitabine Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/12/762

6.7.2020

3.7.2020

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

6.7.2020

3.7.2020

Ecansya

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/12/763

6.7.2020

3.7.2020

Exforge

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/370

6.7.2020

3.7.2020

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

7.7.2020

3.7.2020

Hetlioz

Vanda Pharmaceuticals Germany GmbH

Französische Str. 12, c/o Satellite Office, 10117 Berlin, Deutschland

EU/1/15/1008

6.7.2020

3.7.2020

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

6.7.2020

3.7.2020

Insulatard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/233

6.7.2020

3.7.2020

Lemtrada

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem, België

EU/1/13/869

13.7.2020

3.7.2020

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

7.7.2020

3.7.2020

Mixtard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/231

6.7.2020

3.7.2020

Mysimba

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

7.7.2020

3.7.2020

Pregabalin Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/15/1027

7.7.2020

3.7.2020

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

7.7.2020

3.7.2020

Protaphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/234

6.7.2020

3.7.2020

Suboxone

Indivior Europe Limited

27 Windsor Place, Dublin 2, Ireland

EU/1/06/359

6.7.2020

3.7.2020

Teysuno

Nordic Group B.V.

Siriusdreef 41, 2132 WT Hoofddorp, Nederland

EU/1/11/669

7.7.2020

3.7.2020

Xeloda

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/00/163

6.7.2020

6.7.2020

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/802

7.7.2020

6.7.2020

Kolbam

Retrophin Europe Limited

Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/13/895

17.7.2020

6.7.2020

Picato

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

8.7.2020

13.7.2020

Aripiprazole Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/15/1045

15.7.2020

13.7.2020

BiResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

16.7.2020

13.7.2020

DuoResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

16.7.2020

13.7.2020

Kisqali

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/17/1221

15.7.2020

13.7.2020

Lonquex

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

16.7.2020

13.7.2020

Mulpleo

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/18/1348

17.7.2020

13.7.2020

Namuscla

Lupin Europe GmbH

Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland

EU/1/18/1325

15.7.2020

13.7.2020

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

15.7.2020

13.7.2020

Tracleer

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/220

14.7.2020

16.7.2020

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/802

22.7.2020

16.7.2020

Dukoral

Valneva Sweden AB

105 21 Stockholm, Sverige

EU/1/03/263

23.7.2020

16.7.2020

Toviaz

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/07/386

17.7.2020

17.7.2020

Capecitabine Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/12/762

23.7.2020

17.7.2020

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

21.7.2020

17.7.2020

Filgrastim Hexal

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/08/496

23.7.2020

17.7.2020

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

22.7.2020

17.7.2020

Imlygic

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1064

27.7.2020

17.7.2020

Silodyx

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/607

27.7.2020

17.7.2020

Vihuma

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/16/1168

30.7.2020

23.7.2020

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

27.7.2020

23.7.2020

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

27.7.2020

23.7.2020

Besponsa

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/17/1200

24.7.2020

23.7.2020

Ciambra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/15/1055

27.7.2020

23.7.2020

Dectova

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/18/1349

28.7.2020

23.7.2020

Emtricitabine/Tenofovir disoproxil Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/16/1151

30.7.2020

23.7.2020

Nordimet

Nordic Group B.V.

Siriusdreef 41, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

28.7.2020

23.7.2020

Omidria

Omeros Ireland Limited

Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, Ireland

EU/1/15/1018

27.7.2020

23.7.2020

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

24.7.2020

23.7.2020

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

24.7.2020

23.7.2020

Votubia

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/11/710

24.7.2020

23.7.2020

VPRIV

Shire Pharmaceuticals Ireland Limited

Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/10/646

24.7.2020

24.7.2020

Remsima

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/13/853

27.7.2020

27.7.2020

APTIVUS

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/05/315

28.7.2020

27.7.2020

Buccolam

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/709

29.7.2020

27.7.2020

Cimzia

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/09/544

5.8.2020

27.7.2020

Duzallo

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/18/1300

28.7.2020

27.7.2020

Flucelvax Tetra

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands

EU/1/18/1326

29.7.2020

27.7.2020

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

6.8.2020

27.7.2020

Iclusig

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

4.8.2020

27.7.2020

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

29.7.2020

27.7.2020

Nerlynx

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

EU/1/18/1311

28.7.2020

27.7.2020

Nuwiq

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

4.8.2020

27.7.2020

Orphacol

Laboratoires CTRS

63 rue de l’Est, 92100 Boulogne-Billancourt, France

EU/1/13/870

29.7.2020

27.7.2020

Praxbind

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1056

28.7.2020

27.7.2020

Rilutek

Sanofi Mature IP

54 rue La Boétie, 75008, Paris, France

EU/1/96/010

28.7.2020

27.7.2020

Votrient

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/10/628

28.7.2020

31.7.2020

Cinryze

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688

4.8.2020

31.7.2020

Cosentyx

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/980

4.8.2020

31.7.2020

Evista

SUBSTIPHARM

24 rue Erlanger, 75016 Paris, France

EU/1/98/073

4.8.2020

31.7.2020

Exjade

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/356

4.8.2020

31.7.2020

LIBTAYO

Regeneron Ireland Designated Activity Company (DAC)

Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland

EU/1/19/1376

4.8.2020

31.7.2020

Olanzapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/427

3.8.2020

31.7.2020

Qutenza

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/09/524

4.8.2020

31.7.2020

Retacrit

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/07/431

4.8.2020

31.7.2020

Ruxience

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/20/1431

4.8.2020

31.7.2020

Xolair

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/05/319

4.8.2020

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 13.7.2020 | Kolbam | Retrophin Europe Limited
  Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/13/895 | 15.7.2020 |
| 16.7.2020 | Zurampic | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/15/1080 | 31.7.2020 |
| 31.7.2020 | Duzallo | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/18/1300 | 31.7.2020 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

13.7.2020

Kolbam

Retrophin Europe Limited

Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/13/895

15.7.2020

16.7.2020

Zurampic

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/15/1080

31.7.2020

31.7.2020

Duzallo

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/18/1300

31.7.2020

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.7.2020 | PREVEXXION RN | Marek’s disease vaccine (live recombinant) | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/20/254 | Concentrate and solvent for suspension for injection | QI01AD03 | 23.7.2020 |
| 20.7.2020 | PREVEXXION RN+HVT+IBD | Infectious bursal disease and Marek’s disease vaccine (live recombinant) | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/20/255 | Concentrate and solvent for suspension for injection | QI01AD15 | 23.7.2020 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

20.7.2020

PREVEXXION RN

Marek’s disease vaccine (live recombinant)

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/254

Concentrate and solvent for suspension for injection

QI01AD03

23.7.2020

20.7.2020

PREVEXXION RN+HVT+IBD

Infectious bursal disease and Marek’s disease vaccine (live recombinant)

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/255

Concentrate and solvent for suspension for injection

QI01AD15

23.7.2020

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.7.2020 | Leucofeligen FeLV/RCP | VIRBAC
  1ère avenue 2065 m LID, 06516 Carros, France | EU/2/09/097 | 10.7.2020 |
| 1.7.2020 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/07/078 | 13.7.2020 |
| 1.7.2020 | Zulvac 1 + 8 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/139 | 2.7.2020 |
| 20.7.2020 | FORTEKOR PLUS | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/15/185 | 23.7.2020 |
| 20.7.2020 | Rabitec | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/17/219 | 23.7.2020 |
| 20.7.2020 | Vectormune ND | CEVA-Phylaxia Co. Ltd
  Szállás u. 5, 1107 Budapest, Magyarország | EU/2/15/188 | 24.7.2020 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.7.2020

Leucofeligen FeLV/RCP

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/09/097

10.7.2020

1.7.2020

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

13.7.2020

1.7.2020

Zulvac 1 + 8 Bovis

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/12/139

2.7.2020

20.7.2020

FORTEKOR PLUS

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/15/185

23.7.2020

20.7.2020

Rabitec

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/219

23.7.2020

20.7.2020

Vectormune ND

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

24.7.2020

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 28.8.2020 | EN | Official Journal of the European Union | C 285/11 |
| --- | --- | --- | --- |

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 |

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 |

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

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