# Official Journal C 229/29 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 229 |
| | |
| English edition | Information and Notices | Volume 6129 June 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 229

English edition

Information and Notices

Volume 6129 June 2018

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 229/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 2018(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2018/C 229/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 2018(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 12 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 229/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 2018(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

2018/C 229/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 2018(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)

12

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.6.2018 | EN | Official Journal of the European Union | C 229/1 |
| --- | --- | --- | --- |

29.6.2018

EN

Official Journal of the European Union

C 229/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 2018

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

(2018/C 229/01)

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.5.2018 | Juluca | dolutegravir/rilpivirine | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/18/1282 | Film-coated tablet | J05AR21 | 18.5.2018 |
| 16.5.2018 | KANJINTI | trastuzumab | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/18/1281 | Powder for concentrate for solution for infusion | L01XC03 | 18.5.2018 |
| 16.5.2018 | Prasugrel Mylan | prasugrel | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1273 | Film-coated tablet | B01AC22 | 18.5.2018 |
| 18.5.2018 | Zessly | infliximab | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1280 | Powder for concentrate and diluent for solution for infusion | L04AB02 | 23.5.2018 |
| 22.5.2018 | Pemetrexed Krka | pemetrexed | KRKA, d.d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/18/1283 | Powder for concentrate for solution for infusion | L01BA04 | 24.5.2018 |
| 24.5.2018 | AMGLIDIA | glibenclamide | AMMTeK
  15 rue Béranger, 75003 Paris, France | EU/1/18/1279 | Oral suspension | A10BB01 | 28.5.2018 |
| 24.5.2018 | Rubraca | rucaparib | Clovis Oncology UK Limited
  Sheraton House, Castle Park, Castle Hill, Cambridge CB3 0AX, United Kingdom | EU/1/17/1250 | Film-coated tablet | L01XX55 | 29.5.2018 |

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

16.5.2018

Juluca

dolutegravir/rilpivirine

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/18/1282

Film-coated tablet

J05AR21

18.5.2018

16.5.2018

KANJINTI

trastuzumab

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/18/1281

Powder for concentrate for solution for infusion

L01XC03

18.5.2018

16.5.2018

Prasugrel Mylan

prasugrel

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1273

Film-coated tablet

B01AC22

18.5.2018

18.5.2018

Zessly

infliximab

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1280

Powder for concentrate and diluent for solution for infusion

L04AB02

23.5.2018

22.5.2018

Pemetrexed Krka

pemetrexed

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/18/1283

Powder for concentrate for solution for infusion

L01BA04

24.5.2018

24.5.2018

AMGLIDIA

glibenclamide

AMMTeK

15 rue Béranger, 75003 Paris, France

EU/1/18/1279

Oral suspension

A10BB01

28.5.2018

24.5.2018

Rubraca

rucaparib

Clovis Oncology UK Limited

Sheraton House, Castle Park, Castle Hill, Cambridge CB3 0AX, United Kingdom

EU/1/17/1250

Film-coated tablet

L01XX55

29.5.2018

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

—

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 |
| --- | --- | --- | --- | --- |
| 8.5.2018 | Afinitor | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/538 | 15.5.2018 |
| 8.5.2018 | Aflunov | Seqirus S.r.l.
  Via Fiorentina 1, Siena, Italia | EU/1/10/658 | 15.5.2018 |
| 8.5.2018 | Alofisel | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/17/1261 | 16.5.2018 |
| 8.5.2018 | Busulfan Fresenius Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/14/951 | 16.5.2018 |
| 8.5.2018 | CABOMETYX | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/16/1136 | 15.5.2018 |
| 8.5.2018 | Docetaxel Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/12/770 | 16.5.2018 |
| 8.5.2018 | Effentora | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/441 | 15.5.2018 |
| 8.5.2018 | Elonva | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/609 | 16.5.2018 |
| 8.5.2018 | Flixabi | Samsung Bioepis UK Limited
  5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom | EU/1/16/1106 | 15.5.2018 |
| 8.5.2018 | Inflectra | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/13/854 | 16.5.2018 |
| 8.5.2018 | Instanyl | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/09/531 | 15.5.2018 |
| 8.5.2018 | Invanz | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/02/216 | 15.5.2018 |
| 8.5.2018 | Izba | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/905 | 15.5.2018 |
| 8.5.2018 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 15.5.2018 |
| 8.5.2018 | LIFMIOR | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/16/1165 | 15.5.2018 |
| 8.5.2018 | Lonquex | UAB ‘Sicor Biotech’
  Molėtų pl. 5, 08409 Vilnius, Lietuva | EU/1/13/856 | 15.5.2018 |
| 8.5.2018 | Lynparza | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/959 | 15.5.2018 |
| 8.5.2018 | Odomzo | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/15/1030 | 15.5.2018 |
| 8.5.2018 | Orphacol | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | EU/1/13/870 | 15.5.2018 |
| 8.5.2018 | Oslif Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/586 | 15.5.2018 |
| 8.5.2018 | PecFent | Kyowa Kirin Services Ltd
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/10/644 | 15.5.2018 |
| 8.5.2018 | Pemetrexed Fresenius Kabi | Fresenius Kabi Oncology Plc.
  Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | EU/1/16/1115 | 15.5.2018 |
| 8.5.2018 | Pemetrexed Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/15/1057 | 15.5.2018 |
| 8.5.2018 | Pramipexole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/728 | 15.5.2018 |
| 8.5.2018 | Prometax | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/092 | 15.5.2018 |
| 8.5.2018 | Rekovelle | Ferring Pharmaceuticals A/S
  Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark | EU/1/16/1150 | 15.5.2018 |
| 8.5.2018 | Repatha | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1016 | 15.5.2018 |
| 8.5.2018 | Riluzole Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/12/768 | 15.5.2018 |
| 8.5.2018 | Starlix | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/174 | 15.5.2018 |
| 8.5.2018 | Synagis | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/99/117 | 15.5.2018 |
| 8.5.2018 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 15.5.2018 |
| 8.5.2018 | Tivicay | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/13/892 | 16.5.2018 |
| 8.5.2018 | Travatan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/199 | 15.5.2018 |
| 8.5.2018 | Ulunar Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/917 | 15.5.2018 |
| 8.5.2018 | Votrient | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/628 | 15.5.2018 |
| 8.5.2018 | Zerbaxa | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1032 | 15.5.2018 |
| 16.5.2018 | Giotrif | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/13/879 | 18.5.2018 |
| 16.5.2018 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 18.5.2018 |
| 16.5.2018 | Nordimet | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/16/1124 | 18.5.2018 |
| 16.5.2018 | Odefsey | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1112 | 18.5.2018 |
| 16.5.2018 | Ovaleap | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/13/871 | 18.5.2018 |
| 22.5.2018 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 24.5.2018 |
| 22.5.2018 | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 24.5.2018 |
| 22.5.2018 | Jakavi | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/773 | 25.5.2018 |
| 22.5.2018 | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 24.5.2018 |
| 22.5.2018 | Jylamvo | Therakind Ltd
  314 Regents Park Road, London N3 2JX, United Kingdom | EU/1/17/1172 | 24.5.2018 |
| 22.5.2018 | Osseor | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/04/287 | 24.5.2018 |
| 22.5.2018 | Pedea | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/04/284 | 24.5.2018 |
| 22.5.2018 | Protelos | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/04/288 | 24.5.2018 |
| 22.5.2018 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 24.5.2018 |
| 22.5.2018 | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620 | 24.5.2018 |
| 22.5.2018 | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 24.5.2018 |
| 22.5.2018 | Stribild | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/830 | 24.5.2018 |
| 22.5.2018 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 24.5.2018 |
| 22.5.2018 | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 24.5.2018 |
| 22.5.2018 | Tyverb | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/440 | 24.5.2018 |
| 22.5.2018 | Ultibro Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/862 | 24.5.2018 |
| 22.5.2018 | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 24.5.2018 |
| 22.5.2018 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 24.5.2018 |
| 22.5.2018 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 24.5.2018 |
| 22.5.2018 | Xoterna Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/863 | 24.5.2018 |
| 23.5.2018 | Kaletra | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/01/172 | 25.5.2018 |
| 24.5.2018 | Atazanavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1091 | 28.5.2018 |
| 24.5.2018 | Cayston | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/09/543 | 28.5.2018 |
| 24.5.2018 | Darunavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1140 | 28.5.2018 |
| 24.5.2018 | Emend | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/03/262 | 29.5.2018 |
| 24.5.2018 | Norvir | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/96/016 | 29.5.2018 |
| 24.5.2018 | Procysbi | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/13/861 | 28.5.2018 |
| 24.5.2018 | Vipdomet | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/843 | 28.5.2018 |
| 24.5.2018 | Vipidia | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/844 | 28.5.2018 |
| 25.5.2018 | Armisarte | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/15/1063 | 28.5.2018 |
| 25.5.2018 | Incresync | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/842 | 28.5.2018 |
| 28.5.2018 | Atosiban SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/13/852 | 30.5.2018 |
| 28.5.2018 | AUBAGIO | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/13/838 | 30.5.2018 |
| 28.5.2018 | Bortezomib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1019 | 30.5.2018 |
| 28.5.2018 | Descovy | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1099 | 30.5.2018 |
| 28.5.2018 | Epclusa | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1116 | 30.5.2018 |
| 28.5.2018 | Eviplera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/11/737 | 30.5.2018 |
| 28.5.2018 | Hepsera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/03/251 | 30.5.2018 |
| 28.5.2018 | Ledaga | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/16/1171 | 30.5.2018 |
| 28.5.2018 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 30.5.2018 |
| 28.5.2018 | Plavix | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | EU/1/98/069 | 30.5.2018 |
| 28.5.2018 | Senshio | Shionogi Limited
  33 Kingsway, London WC2B 6UF, United Kingdom | EU/1/14/978 | 30.5.2018 |
| 28.5.2018 | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/13/837 | 30.5.2018 |
| 28.5.2018 | Temodal | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/98/096 | 30.5.2018 |
| 28.5.2018 | Vemlidy | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1154 | 30.5.2018 |
| 28.5.2018 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/918 | 30.5.2018 |
| 31.5.2018 | Alecensa | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/16/1169 | 4.6.2018 |
| 31.5.2018 | Champix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/360 | 4.6.2018 |
| 31.5.2018 | Chenodeoxycholic acid Leadiant | Leadiant GmbH
  Liebherrstraße 22, 80538 München, Deutschland | EU/1/16/1110 | 4.6.2018 |
| 31.5.2018 | DuoTrav | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/338 | 5.6.2018 |
| 31.5.2018 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/691 | 4.6.2018 |
| 31.5.2018 | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 4.6.2018 |
| 31.5.2018 | Perjeta | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/813 | 4.6.2018 |
| 31.5.2018 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363 | 4.6.2018 |
| 31.5.2018 | Tadalafil Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/17/1177 | 4.6.2018 |
| 31.5.2018 | Twynsta | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/10/648 | 4.6.2018 |
| 31.5.2018 | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 4.6.2018 |
| 31.5.2018 | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | 4.6.2018 |
| 31.5.2018 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 4.6.2018 |

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

8.5.2018

Afinitor

Novartis Europharm Limited

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

EU/1/09/538

15.5.2018

8.5.2018

Aflunov

Seqirus S.r.l.

Via Fiorentina 1, Siena, Italia

EU/1/10/658

15.5.2018

8.5.2018

Alofisel

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/17/1261

16.5.2018

8.5.2018

Busulfan Fresenius Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/14/951

16.5.2018

8.5.2018

CABOMETYX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

15.5.2018

8.5.2018

Docetaxel Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/12/770

16.5.2018

8.5.2018

Effentora

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/441

15.5.2018

8.5.2018

Elonva

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/609

16.5.2018

8.5.2018

Flixabi

Samsung Bioepis UK Limited

5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom

EU/1/16/1106

15.5.2018

8.5.2018

Inflectra

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/13/854

16.5.2018

8.5.2018

Instanyl

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/09/531

15.5.2018

8.5.2018

Invanz

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/02/216

15.5.2018

8.5.2018

Izba

Novartis Europharm Limited

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

EU/1/13/905

15.5.2018

8.5.2018

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

15.5.2018

8.5.2018

LIFMIOR

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/16/1165

15.5.2018

8.5.2018

Lonquex

UAB ‘Sicor Biotech’

Molėtų pl. 5, 08409 Vilnius, Lietuva

EU/1/13/856

15.5.2018

8.5.2018

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

15.5.2018

8.5.2018

Odomzo

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/15/1030

15.5.2018

8.5.2018

Orphacol

Laboratoires CTRS

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

EU/1/13/870

15.5.2018

8.5.2018

Oslif Breezhaler

Novartis Europharm Limited

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

EU/1/09/586

15.5.2018

8.5.2018

PecFent

Kyowa Kirin Services Ltd

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/10/644

15.5.2018

8.5.2018

Pemetrexed Fresenius Kabi

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom

EU/1/16/1115

15.5.2018

8.5.2018

Pemetrexed Hospira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/15/1057

15.5.2018

8.5.2018

Pramipexole Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/11/728

15.5.2018

8.5.2018

Prometax

Novartis Europharm Limited

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

EU/1/98/092

15.5.2018

8.5.2018

Rekovelle

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark

EU/1/16/1150

15.5.2018

8.5.2018

Repatha

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

15.5.2018

8.5.2018

Riluzole Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/12/768

15.5.2018

8.5.2018

Starlix

Novartis Europharm Limited

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

EU/1/01/174

15.5.2018

8.5.2018

Synagis

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/99/117

15.5.2018

8.5.2018

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

15.5.2018

8.5.2018

Tivicay

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/13/892

16.5.2018

8.5.2018

Travatan

Novartis Europharm Limited

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

EU/1/01/199

15.5.2018

8.5.2018

Ulunar Breezhaler

Novartis Europharm Limited

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

EU/1/14/917

15.5.2018

8.5.2018

Votrient

Novartis Europharm Limited

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

EU/1/10/628

15.5.2018

8.5.2018

Zerbaxa

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/15/1032

15.5.2018

16.5.2018

Giotrif

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/13/879

18.5.2018

16.5.2018

Januvia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/383

18.5.2018

16.5.2018

Nordimet

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

18.5.2018

16.5.2018

Odefsey

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1112

18.5.2018

16.5.2018

Ovaleap

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/871

18.5.2018

22.5.2018

Bosulif

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/13/818

24.5.2018

22.5.2018

Efficib

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457

24.5.2018

22.5.2018

Jakavi

Novartis Europharm Limited

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

EU/1/12/773

25.5.2018

22.5.2018

Janumet

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455

24.5.2018

22.5.2018

Jylamvo

Therakind Ltd

314 Regents Park Road, London N3 2JX, United Kingdom

EU/1/17/1172

24.5.2018

22.5.2018

Osseor

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/04/287

24.5.2018

22.5.2018

Pedea

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/04/284

24.5.2018

22.5.2018

Protelos

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/04/288

24.5.2018

22.5.2018

Ristaben

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/621

24.5.2018

22.5.2018

Ristfor

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/620

24.5.2018

22.5.2018

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

24.5.2018

22.5.2018

Stribild

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/830

24.5.2018

22.5.2018

Tesavel

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/435

24.5.2018

22.5.2018

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

24.5.2018

22.5.2018

Tyverb

Novartis Europharm Limited

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

EU/1/07/440

24.5.2018

22.5.2018

Ultibro Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/862

24.5.2018

22.5.2018

Velmetia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456

24.5.2018

22.5.2018

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

24.5.2018

22.5.2018

Xelevia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/382

24.5.2018

22.5.2018

Xoterna Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/863

24.5.2018

23.5.2018

Kaletra

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/01/172

25.5.2018

24.5.2018

Atazanavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1091

28.5.2018

24.5.2018

Cayston

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/09/543

28.5.2018

24.5.2018

Darunavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1140

28.5.2018

24.5.2018

Emend

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/03/262

29.5.2018

24.5.2018

Norvir

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/96/016

29.5.2018

24.5.2018

Procysbi

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/13/861

28.5.2018

24.5.2018

Vipdomet

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/843

28.5.2018

24.5.2018

Vipidia

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/844

28.5.2018

25.5.2018

Armisarte

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/15/1063

28.5.2018

25.5.2018

Incresync

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/842

28.5.2018

28.5.2018

Atosiban SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/13/852

30.5.2018

28.5.2018

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/13/838

30.5.2018

28.5.2018

Bortezomib Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1019

30.5.2018

28.5.2018

Descovy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1099

30.5.2018

28.5.2018

Epclusa

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

30.5.2018

28.5.2018

Eviplera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/11/737

30.5.2018

28.5.2018

Hepsera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/251

30.5.2018

28.5.2018

Ledaga

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/16/1171

30.5.2018

28.5.2018

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

30.5.2018

28.5.2018

Plavix

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/98/069

30.5.2018

28.5.2018

Senshio

Shionogi Limited

33 Kingsway, London WC2B 6UF, United Kingdom

EU/1/14/978

30.5.2018

28.5.2018

Tecfidera

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/13/837

30.5.2018

28.5.2018

Temodal

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/98/096

30.5.2018

28.5.2018

Vemlidy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1154

30.5.2018

28.5.2018

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/918

30.5.2018

31.5.2018

Alecensa

Roche Registration GmbH

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

EU/1/16/1169

4.6.2018

31.5.2018

Champix

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/360

4.6.2018

31.5.2018

Chenodeoxycholic acid Leadiant

Leadiant GmbH

Liebherrstraße 22, 80538 München, Deutschland

EU/1/16/1110

4.6.2018

31.5.2018

DuoTrav

Novartis Europharm Limited

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

EU/1/06/338

5.6.2018

31.5.2018

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/691

4.6.2018

31.5.2018

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

4.6.2018

31.5.2018

Perjeta

Roche Registration GmbH

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

EU/1/13/813

4.6.2018

31.5.2018

Sprycel

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/363

4.6.2018

31.5.2018

Tadalafil Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/17/1177

4.6.2018

31.5.2018

Twynsta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/10/648

4.6.2018

31.5.2018

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

4.6.2018

31.5.2018

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

4.6.2018

31.5.2018

Yervoy

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/11/698

4.6.2018

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

—

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 |
| --- | --- | --- | --- | --- |
| 8.5.2018 | Imatinib Teva B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/17/1243 | 15.5.2018 |

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

8.5.2018

Imatinib Teva B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1243

15.5.2018

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.5.2018 | Bravecto Plus | fluralaner/moxidectin | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/18/224 | Spot-on solution | QP54AB52 | 16.5.2018 |

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

8.5.2018

Bravecto Plus

fluralaner/moxidectin

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/18/224

Spot-on solution

QP54AB52

16.5.2018

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

—

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 |
| --- | --- | --- | --- | --- |
| 8.5.2018 | Fevaxyn Pentofel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/96/002 | 15.5.2018 |
| 8.5.2018 | Semintra | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/146 | 16.5.2018 |
| 8.5.2018 | Suvaxyn Aujeszky 783 + O/W | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/98/009 | 16.5.2018 |
| 25.5.2018 | GALLIPRANT | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/17/221 | 29.5.2018 |
| 25.5.2018 | Osurnia | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/14/170 | 29.5.2018 |
| 25.5.2018 | Profender | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/05/054 | 29.5.2018 |
| 25.5.2018 | Sevohale | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/16/196 | 30.5.2018 |

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

8.5.2018

Fevaxyn Pentofel

Zoetis Belgium S.A.

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

EU/2/96/002

15.5.2018

8.5.2018

Semintra

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/146

16.5.2018

8.5.2018

Suvaxyn Aujeszky 783 + O/W

Zoetis Belgium S.A.

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

EU/2/98/009

16.5.2018

25.5.2018

GALLIPRANT

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/221

29.5.2018

25.5.2018

Osurnia

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/14/170

29.5.2018

25.5.2018

Profender

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/05/054

29.5.2018

25.5.2018

Sevohale

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/16/196

30.5.2018

| — | Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorization (Article 38 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 |
| --- | --- | --- | --- | --- |
| 8.5.2018 | BTVPUR AlSap 1 | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/10/112 | 16.5.2018 |
| 8.5.2018 | BTVPUR AlSap 8 | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/09/094 | 16.5.2018 |
| 25.5.2018 | Meloxivet | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/07/077 | 29.5.2018 |

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

8.5.2018

BTVPUR AlSap 1

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/10/112

16.5.2018

8.5.2018

BTVPUR AlSap 8

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/09/094

16.5.2018

25.5.2018

Meloxivet

Eli Lilly and Company Limited

Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/07/077

29.5.2018

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 |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

---

| 29.6.2018 | EN | Official Journal of the European Union | C 229/12 |
| --- | --- | --- | --- |

29.6.2018

EN

Official Journal of the European Union

C 229/12

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 2018

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2018/C 229/02)

| — | Issuing, maintenance or modification of a national marketing authorisation |
| --- | --- |

—

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 8.5.2018 | Girolan and its ass. name Apralan | Apramycin sulfate | See Annex I | See Annex I | 14.5.2018 |
| 25.5.2018 | Seresto and its associated name Foresto | imidacloprid/flumethrin | See Annex II | See Annex II | 28.5.2018 |
| 31.5.2018 | Valproate | medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium | See Annex III | See Annex III | 1.6.2018 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

8.5.2018

Girolan and its ass. name Apralan

Apramycin sulfate

See Annex I

See Annex I

14.5.2018

25.5.2018

Seresto and its associated name Foresto

imidacloprid/flumethrin

See Annex II

See Annex II

28.5.2018

31.5.2018

Valproate

medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium

See Annex III

See Annex III

1.6.2018

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(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.

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ANNEX I

List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holders in the Member States

| Member State EU/EEA | Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Denmark | Elanco Animal Health A/S
  Eli Lilly Danmark A/S
  Lyskær 3E, 2 tv.
  DK-2730 Herlev
  Denmark | Apralan Vet. | Apramycin sulfate | Apramycin sulfate 333 mg/ml equivalent to apramycin 230 mg/ml | Powder for use in drinking water | Calves, pigs | Oral |
| France | Lilly France
  24 Boulevard Vital Bouhot
  92200 Neuilly Sur Seine
  France | APRALAN BUVABLE | Apramycin sulfate | 1 g powder contains 1 g apramycin (as sulfate) | Powder for drinking solution | Calves, pigs, rabbits | Oral |
| Germany | Lilly Deutschland GmbH
  Abt. Elanco Animal Health
  Werner-Reimers-Straße 2-4
  D-61352 Bad Homburg
  Germany | Apralan soluble, 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine (Läufer, Ferkel), Apramycin (als Apramycinsulfat) | Apramycin sulfate | 1 g powder contains 500 mg apramycin as apramycin sulfate in 2.2 ml equivalent to 1 g powder | Powder for use in drinking water | Pigs (piglets and growers) | Oral |
| Ireland | Eli Lilly and Company Limited
  Elanco Animal Health
  Priestly Road
  Basingstoke
  Hampshire
  RG24 9NL
  United Kingdom | Apralan Soluble Powder for oral solution | Apramycin sulfate | 100 % w/w | Powder for oral solution | Calves, pigs, chickens | Oral |
| Italy | Eli Lilly Italia SpA
  Via A. Gramsci, 731/733
  50019 Sesto Fiorentino
  (Firenze)
  Italy | Apralan Solubile polvere per soluzione orale per Suini, Polli da carne e Conigli | Apramycin sulfate | 100 g powder contain 100 g apramycin sulfate | Powder for oral solution | Pigs, Broilers, Rabbits | Oral |
| Portugal | Lilly Portugal
  Produtos Farmacêuticos, Lda
  Torre Ocidente
  Rua Galileu Galilei, N.o 2, Piso 7 Fracção A/D
  1500-392 Lisboa
  Portugal | Apralan Pó para solução oral para administração na água de bebida para vitelos, suínos e frangos | Apramycin sulfate | Apramycin sulfate equivalent to 50 g apramycin activity per bottle.
  Apramycin sulfate equivalent to 1000 g apramycin activity per bag. | Powder for oral solution | Calves, pigs, chickens | Oral |
| Spain | Elanco Valquímica, S.A.
  Avda. de la Industria, no 30
  Polígono Industrial de Alcobendas
  28108 Alcobendas (Madrid)
  Spain | Girolan | Apramycin sulfate | Apramycin sulfate equivalent to 50 g apramycin activity per bottle.
  Apramycin sulfate equivalent to 1000 g apramycin activity per bag. | Powder for oral solution | Cattle, pigs, chickens, rabbits | Oral |
| The Netherlands | Elanco Europe Ltd Lilly House Priestley Road Basingstoke
  RG24 9NL
  United Kingdom | Apralan oplosbaar | Apramycin sulfate | 100 % | Powder for oral administration | Pre-ruminant calves, pigs, broilers | Oral |
| United Kingdom | Eli Lilly and Company Limited
  Elanco Animal Health
  Priestley Road
  Basingstoke
  Hampshire
  RG24 9NL
  United Kingdom | Apralan Soluble Powder for oral solution | Apramycin sulfate | Apramycin sulfate equivalent to 50 g apramycin activity per bottle.
  Apramycin sulfate equivalent to 1 g apramycin activity per sachet.
  Apramycin sulfate equivalent to 1000 g apramycin activity per bag. | Powder for oral solution | Calves, Pigs, Chickens | Oral |

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Denmark

Elanco Animal Health A/S

Eli Lilly Danmark A/S

Lyskær 3E, 2 tv.

DK-2730 Herlev

Denmark

Apralan Vet.

Apramycin sulfate

Apramycin sulfate 333 mg/ml equivalent to apramycin 230 mg/ml

Powder for use in drinking water

Calves, pigs

Oral

France

Lilly France

24 Boulevard Vital Bouhot

92200 Neuilly Sur Seine

France

APRALAN BUVABLE

Apramycin sulfate

1 g powder contains 1 g apramycin (as sulfate)

Powder for drinking solution

Calves, pigs, rabbits

Oral

Germany

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Straße 2-4

D-61352 Bad Homburg

Germany

Apralan soluble, 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine (Läufer, Ferkel), Apramycin (als Apramycinsulfat)

Apramycin sulfate

1 g powder contains 500 mg apramycin as apramycin sulfate in 2.2 ml equivalent to 1 g powder

Powder for use in drinking water

Pigs (piglets and growers)

Oral

Ireland

Eli Lilly and Company Limited

Elanco Animal Health

Priestly Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Apralan Soluble Powder for oral solution

Apramycin sulfate

100 % w/w

Powder for oral solution

Calves, pigs, chickens

Oral

Italy

Eli Lilly Italia SpA

Via A. Gramsci, 731/733

50019 Sesto Fiorentino

(Firenze)

Italy

Apralan Solubile polvere per soluzione orale per Suini, Polli da carne e Conigli

Apramycin sulfate

100 g powder contain 100 g apramycin sulfate

Powder for oral solution

Pigs, Broilers, Rabbits

Oral

Portugal

Lilly Portugal

Produtos Farmacêuticos, Lda

Torre Ocidente

Rua Galileu Galilei, N.o 2, Piso 7 Fracção A/D

1500-392 Lisboa

Portugal

Apralan Pó para solução oral para administração na água de bebida para vitelos, suínos e frangos

Apramycin sulfate

Apramycin sulfate equivalent to 50 g apramycin activity per bottle.

Apramycin sulfate equivalent to 1000 g apramycin activity per bag.

Powder for oral solution

Calves, pigs, chickens

Oral

Spain

Elanco Valquímica, S.A.

Avda. de la Industria, no 30

Polígono Industrial de Alcobendas

28108 Alcobendas (Madrid)

Spain

Girolan

Apramycin sulfate

Apramycin sulfate equivalent to 50 g apramycin activity per bottle.

Apramycin sulfate equivalent to 1000 g apramycin activity per bag.

Powder for oral solution

Cattle, pigs, chickens, rabbits

Oral

The Netherlands

Elanco Europe Ltd Lilly House Priestley Road Basingstoke

RG24 9NL

United Kingdom

Apralan oplosbaar

Apramycin sulfate

100 %

Powder for oral administration

Pre-ruminant calves, pigs, broilers

Oral

United Kingdom

Eli Lilly and Company Limited

Elanco Animal Health

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Apralan Soluble Powder for oral solution

Apramycin sulfate

Apramycin sulfate equivalent to 50 g apramycin activity per bottle.

Apramycin sulfate equivalent to 1 g apramycin activity per sachet.

Apramycin sulfate equivalent to 1000 g apramycin activity per bag.

Powder for oral solution

Calves, Pigs, Chickens

Oral

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ANNEX II

List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States

| Member State EU/EEA | Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Bayer Austria Ges.m.b.H
  Herbstraße 6-10
  A-1160 Wien, Austria | Seresto 1,25  g +0,56  g Halsband für Katzen und Hunde ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Austria | Bayer Austria Ges.m.b.H
  Herbstraße 6-10
  A-1160 Wien, Austria | Seresto 1,25  g +0,56  g Halsband für Hunde ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Austria | Bayer Austria Ges.m.b.H
  Herbstraße 6-10
  A-1160 Wien, Austria | Seresto 4,50  g +2,03  g Halsband für Hunde > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Belgium | Bayer SA-NV,
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen),
  Belgium | Seresto 1,25  g +0,56  g halsband voor katten en honden ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Belgium | Bayer SA-NV,
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen),
  Belgium | Seresto 1,25  g +0,56  g Halsband voor honden ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Belgium | Bayer SA-NV,
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen),
  Belgium | Seresto 4,50  g +2,03  g halsband voor honden > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Bulgaria | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Форесто 1,25  g +0,56  g, противопаразитна каишка за котки и кучета ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Bulgaria | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Форесто 4,50  g +2,03  g, противопаразитна каишка за кучета > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Cyprus | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto 1.25 g + 0.56 g, περιλαίμιο για γάτες και σκύλους ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Cyprus | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto 1.25 g + 0.56 g, περιλαίμιο για σκύλους ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Cyprus | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto 4,50  g +2,03  g, περιλαίμιο για σκύλους > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Czech Republic | Bayer s.r.o., Siemensova 2717/4, 155 80 Praha 5,
  Czech Republic | Foresto 1,25  +0,56 obojek pro kocky a psy ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Czech Republic | Bayer s.r.o., Siemensova 2717/4, 155 80 Praha 5,
  Czech Republic | Foresto 4,5  +2,03 obojek pro psy > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Denmark | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 1,25  g/0,56  g halsbånd til katte og hunde ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Denmark | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet 1,25  g/0,56  g halsbånd til hunde ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Denmark | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 4,5  g/2,03  g halsbånd til hunde > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Estonia | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 1.25 g + 0.56 g ravimkaelarihm kassidele ja koertele ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Estonia | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 4.50 g + 2.03 g ravimkaelarihm koertele > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Finland | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 1,25 /0,56  g panta kissoille ja koirille alle 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Finland | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 1,25 /0,56  g panta koirille alle 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Finland | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 4,5 /2,03  g panta koirille yli 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| France | Bayer Healthcare,
  220 Avenue de la Recherche
  59120, Loos,
  France | Seresto collier petits chiens | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| France | Bayer Healthcare,
  220 Avenue de la Recherche
  59120, Loos,
  France | Seresto collier grands chiens | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Germany | Bayer Vital GmbH,
  Geschäftsbereich Tiergesundheit
  51368 Leverkusen
  Germany | Seresto 1,25  g +0,56  g Halsband für Katzen und Hunde ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Germany | Bayer Vital GmbH,
  Geschäftsbereich Tiergesundheit
  51368 Leverkusen
  Germany | Seresto 1,25  g +0,56  g Halsband für Hunde ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Germany | Bayer Vital GmbH,
  Geschäftsbereich Tiergesundheit
  51368 Leverkusen Germany | Seresto 4.50 g + 2.03 g Halsband für Hunde > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Greece | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | SERESTO, Περιλαίμιο (1.250 + 0.563)g/περιλαίμιο 38 cm (12.5)g Για γάτες και σκύλους ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Greece | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | SERESTO, Περιλαίμιο (1.250 + 0.563)g/περιλαίμιο 38 cm (12.5)g Για σκύλους (≤ 8 kg) | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Greece | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | SERESTO, Περιλαίμιο (4,500  +2,025 )g/περιλαίμιο 70 cm (45)g Για σκύλους (> 8 kg) | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Hungary | Bayer Hungaria Kft.,
  1123 Budapest, Alkotás u.50,
  Hungary | Foresto 1,25  g +0,56  g nyakörv macskáknak és kutyáknak ≤ 8 kg A.U.V. | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Hungary | Bayer Hungaria Kft.,
  1123 Budapest, Alkotás u.50,
  Hungary | Foresto 4,50  g +2,03  g nyakörv kutyáknak > 8 kg A.U.V. | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Iceland | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 1,25  g/0,56  g hálsband fyrir ketti og hunda ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Iceland | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 1,25  g/0,56  g hálsband fyrir hunda ≤ 8 kg. | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Iceland | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 4,50  g/2,03  g hálsband fyrir hunda > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Ireland | Bayer Ltd,
  The Atrium, Blackthorn Road, Dublin 18, Ireland | Seresto 1,25  g +0,56  g collar for dogs ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Ireland | Bayer Ltd,
  The Atrium, Blackthorn Road, Dublin 18,
  Ireland | Seresto 4,50  g +2,03  g collar for dogs > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Italy | Bayer S.p.A.,
  Viale Certosa, 130
  20156 Milano
  Italy | Seresto 1,25  g +0,56  g, collare per cani ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Italy | Bayer S.p.A.,
  Viale Certosa, 130
  20156 Milano
  Italy | Seresto 1,25  g +0,56  g, collare per cani ≤ 8 kg e gatti | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Italy | Bayer S.p.A.,
  Viale Certosa, 130
  20156 Milano
  Italy | Seresto 4,50  g +2,03  g, collare per cani > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Latvia | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 1,25  g +0,56  g kakla siksna kaķiem un suņiem ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Latvia | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 4,5  g +2,03  g kakla siksna suņiem > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Lithuania | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 1,25  g +0,56  g, antkaklis katėms ir šunims iki 8 kg svorio | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Lithuania | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 4,50  g +2,03  g, antkaklis šunims, sveriantiems daugiau kaip 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Luxembourg | Bayer SA-NV,
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen),
  Belgium | Seresto 1,25  g +0,56  g collier pour chats et chiens ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Luxembourg | Bayer SA-NV,
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen),
  Belgium | Seresto 1,25  g +0,56  g collier pour chiens ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Luxembourg | Bayer SA-NV,
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen),
  Belgium | Seresto 4,50  g +2,03  g collier pour chiens > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Netherlands | Bayer B.V.,
  Animal Health Division
  Energieweg 1
  3641 RT Mijdrecht
  Netherlands | Seresto 4,50  g +2,03  g halsband voor honden > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Netherlands | Bayer B.V.,
  Animal Health Division
  Energieweg 1
  3641 RT Mijdrecht
  Netherlands | Seresto 1,25  g +0,56  g halsband voor honden ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Netherlands | Bayer B.V.,
  Animal Health Division
  Energieweg 1
  3641 RT Mijdrecht
  Netherlands | Seresto 1,25  g +0,56  g halsband voor katten en honden < 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Norway | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 1,25  g/0,56  g halsbånd til katt og hund ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Norway | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto 1,25  g/0,56  g halsbånd til hund ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Norway | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. 4,50  g/2,03  g halsbånd til hund > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Poland | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 1,25  g +0,56  g obroża dla kotów i psów o masie ciala ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Poland | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 4,50  g +2,03  g obroża dla psow o masie ciala > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Portugal | Bayer Portugal, Lda.,
  Rua Quinta do Pinheiro, 5,
  2794-003 Carnaxide
  Portugal | Seresto coleira 1,25  g +0,56  g para gatos e cães ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Portugal | Bayer Portugal, Lda.,
  Rua Quinta do Pinheiro, 5,
  2794-003 Carnaxide
  Portugal | Seresto coleira 1,25  g +0,56  g para cães ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Portugal | Bayer Portugal, Lda.,
  Rua Quinta do Pinheiro, 5,
  2794-003 Carnaxide
  Portugal | Seresto coleira 4,50  g +2,03  g para cães > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Romania | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 1.25 g + 0.56 g, zgardă antiparazitară pentru pisici şi câini ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Romania | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Foresto 4.50 g + 2.03 g, g zgardă antiparazitară pentru câini > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Slovakia | Bayer s.r.o., Siemensova 2717/4, 155 80 Praha 5,
  Czech Republic | Foresto 1,25  g +0,56  g obojok pre macky a psy ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Slovakia | Bayer s.r.o., Siemensova 2717/4, 155 80 Praha 5,
  Czech Republic | Foresto 4,50  g +2,03  g obojok pre psy > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Slovenia | Bayer d.o.o.,
  Bravničarjeva 13
  1000 Ljubljana
  Slovenia | Foresto 1,25  g +0,56  g, ovratnica za mačke in pse ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Slovenia | Bayer d.o.o.,
  Bravničarjeva 13
  1000 Ljubljana
  Slovenia | Foresto 4,50  g +2,03  g, ovratnica za pse > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Spain | Bayer Hispania, S.L.,
  Av. Baix Lobregat, 3-5
  08970 Sant Joan Despí
  (Barcelona)
  Spain | Seresto 1,25  g +0,56  g collar para perros ≤ 8 kg y gatos | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Spain | Bayer Hispania, S.L.,
  Av. Baix Lobregat, 3-5
  08970 Sant Joan Despí
  (Barcelona)
  Spain | Seresto 1,25  g +0,56  g collar para perros ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Spain | Bayer Hispania, S.L.,
  Av. Baix Lobregat, 3-5
  08970 Sant Joan Despí
  (Barcelona)
  Spain | Seresto 4,50  g +2,03  g collar para perros > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| Sweden | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet för katt och hund upp till 8 kg, 1,25  g +0,56  g halsband | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Sweden | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet. för hund upp till 8 kg 1,25  g +0,56  g halsband | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| Sweden | Bayer Animal Health GmbH,
  51368 Leverkusen
  Germany | Seresto vet för hund över 8 kg 4,50  g +2,03  g halsband | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |
| United Kingdom | Bayer plc,
  400 South Oak Way
  Green Park
  Reading
  Berkshire
  RG2 6AD
  United Kingdom | Seresto 1,25  +0,56 collar for cats | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| United Kingdom | Bayer plc,
  400 South Oak Way
  Green Park
  Reading
  Berkshire
  RG2 6AD
  United Kingdom | Seresto 1,25  +0,56 collar for dogs ≤ 8 kg | imidacloprid/
  flumethrin | 1.25 g imidacloprid/0.56 g flumethrin | Collar | Dogs | Cutaneous use |
| United Kingdom | Bayer plc,
  400 South Oak Way
  Green Park
  Reading
  Berkshire
  RG2 6AD
  United Kingdom | Seresto 4,50  +2,03 collar for dogs > 8 kg | imidacloprid/
  flumethrin | 4.50 g imidacloprid/2.03 g flumethrin | Collar | Dogs | Cutaneous use |

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Bayer Austria Ges.m.b.H

Herbstraße 6-10

A-1160 Wien, Austria

Seresto 1,25  g +0,56  g Halsband für Katzen und Hunde ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Austria

Bayer Austria Ges.m.b.H

Herbstraße 6-10

A-1160 Wien, Austria

Seresto 1,25  g +0,56  g Halsband für Hunde ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Austria

Bayer Austria Ges.m.b.H

Herbstraße 6-10

A-1160 Wien, Austria

Seresto 4,50  g +2,03  g Halsband für Hunde > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Belgium

Bayer SA-NV,

J.E. Mommaertslaan 14

1831 Diegem (Machelen),

Belgium

Seresto 1,25  g +0,56  g halsband voor katten en honden ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Belgium

Bayer SA-NV,

J.E. Mommaertslaan 14

1831 Diegem (Machelen),

Belgium

Seresto 1,25  g +0,56  g Halsband voor honden ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Belgium

Bayer SA-NV,

J.E. Mommaertslaan 14

1831 Diegem (Machelen),

Belgium

Seresto 4,50  g +2,03  g halsband voor honden > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Bulgaria

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Форесто 1,25  g +0,56  g, противопаразитна каишка за котки и кучета ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Bulgaria

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Форесто 4,50  g +2,03  g, противопаразитна каишка за кучета > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Cyprus

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto 1.25 g + 0.56 g, περιλαίμιο για γάτες και σκύλους ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Cyprus

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto 1.25 g + 0.56 g, περιλαίμιο για σκύλους ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Cyprus

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto 4,50  g +2,03  g, περιλαίμιο για σκύλους > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Czech Republic

Bayer s.r.o., Siemensova 2717/4, 155 80 Praha 5,

Czech Republic

Foresto 1,25  +0,56 obojek pro kocky a psy ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Czech Republic

Bayer s.r.o., Siemensova 2717/4, 155 80 Praha 5,

Czech Republic

Foresto 4,5  +2,03 obojek pro psy > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Denmark

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 1,25  g/0,56  g halsbånd til katte og hunde ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Denmark

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet 1,25  g/0,56  g halsbånd til hunde ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Denmark

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 4,5  g/2,03  g halsbånd til hunde > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Estonia

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 1.25 g + 0.56 g ravimkaelarihm kassidele ja koertele ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Estonia

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 4.50 g + 2.03 g ravimkaelarihm koertele > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Finland

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 1,25 /0,56  g panta kissoille ja koirille alle 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Finland

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 1,25 /0,56  g panta koirille alle 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Finland

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 4,5 /2,03  g panta koirille yli 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

France

Bayer Healthcare,

220 Avenue de la Recherche

59120, Loos,

France

Seresto collier petits chiens

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

France

Bayer Healthcare,

220 Avenue de la Recherche

59120, Loos,

France

Seresto collier grands chiens

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Germany

Bayer Vital GmbH,

Geschäftsbereich Tiergesundheit

51368 Leverkusen

Germany

Seresto 1,25  g +0,56  g Halsband für Katzen und Hunde ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Germany

Bayer Vital GmbH,

Geschäftsbereich Tiergesundheit

51368 Leverkusen

Germany

Seresto 1,25  g +0,56  g Halsband für Hunde ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Germany

Bayer Vital GmbH,

Geschäftsbereich Tiergesundheit

51368 Leverkusen Germany

Seresto 4.50 g + 2.03 g Halsband für Hunde > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Greece

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

SERESTO, Περιλαίμιο (1.250 + 0.563)g/περιλαίμιο 38 cm (12.5)g Για γάτες και σκύλους ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Greece

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

SERESTO, Περιλαίμιο (1.250 + 0.563)g/περιλαίμιο 38 cm (12.5)g Για σκύλους (≤ 8 kg)

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Greece

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

SERESTO, Περιλαίμιο (4,500  +2,025 )g/περιλαίμιο 70 cm (45)g Για σκύλους (> 8 kg)

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Hungary

Bayer Hungaria Kft.,

1123 Budapest, Alkotás u.50,

Hungary

Foresto 1,25  g +0,56  g nyakörv macskáknak és kutyáknak ≤ 8 kg A.U.V.

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Hungary

Bayer Hungaria Kft.,

1123 Budapest, Alkotás u.50,

Hungary

Foresto 4,50  g +2,03  g nyakörv kutyáknak > 8 kg A.U.V.

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Iceland

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 1,25  g/0,56  g hálsband fyrir ketti og hunda ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Iceland

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 1,25  g/0,56  g hálsband fyrir hunda ≤ 8 kg.

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Iceland

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 4,50  g/2,03  g hálsband fyrir hunda > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Ireland

Bayer Ltd,

The Atrium, Blackthorn Road, Dublin 18, Ireland

Seresto 1,25  g +0,56  g collar for dogs ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Ireland

Bayer Ltd,

The Atrium, Blackthorn Road, Dublin 18,

Ireland

Seresto 4,50  g +2,03  g collar for dogs > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Italy

Bayer S.p.A.,

Viale Certosa, 130

20156 Milano

Italy

Seresto 1,25  g +0,56  g, collare per cani ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Italy

Bayer S.p.A.,

Viale Certosa, 130

20156 Milano

Italy

Seresto 1,25  g +0,56  g, collare per cani ≤ 8 kg e gatti

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Italy

Bayer S.p.A.,

Viale Certosa, 130

20156 Milano

Italy

Seresto 4,50  g +2,03  g, collare per cani > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Latvia

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 1,25  g +0,56  g kakla siksna kaķiem un suņiem ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Latvia

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 4,5  g +2,03  g kakla siksna suņiem > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Lithuania

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 1,25  g +0,56  g, antkaklis katėms ir šunims iki 8 kg svorio

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Lithuania

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 4,50  g +2,03  g, antkaklis šunims, sveriantiems daugiau kaip 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Luxembourg

Bayer SA-NV,

J.E. Mommaertslaan 14

1831 Diegem (Machelen),

Belgium

Seresto 1,25  g +0,56  g collier pour chats et chiens ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Luxembourg

Bayer SA-NV,

J.E. Mommaertslaan 14

1831 Diegem (Machelen),

Belgium

Seresto 1,25  g +0,56  g collier pour chiens ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Luxembourg

Bayer SA-NV,

J.E. Mommaertslaan 14

1831 Diegem (Machelen),

Belgium

Seresto 4,50  g +2,03  g collier pour chiens > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Netherlands

Bayer B.V.,

Animal Health Division

Energieweg 1

3641 RT Mijdrecht

Netherlands

Seresto 4,50  g +2,03  g halsband voor honden > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Netherlands

Bayer B.V.,

Animal Health Division

Energieweg 1

3641 RT Mijdrecht

Netherlands

Seresto 1,25  g +0,56  g halsband voor honden ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Netherlands

Bayer B.V.,

Animal Health Division

Energieweg 1

3641 RT Mijdrecht

Netherlands

Seresto 1,25  g +0,56  g halsband voor katten en honden < 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Norway

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 1,25  g/0,56  g halsbånd til katt og hund ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Norway

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto 1,25  g/0,56  g halsbånd til hund ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Norway

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. 4,50  g/2,03  g halsbånd til hund > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Poland

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 1,25  g +0,56  g obroża dla kotów i psów o masie ciala ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Poland

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 4,50  g +2,03  g obroża dla psow o masie ciala > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Portugal

Bayer Portugal, Lda.,

Rua Quinta do Pinheiro, 5,

2794-003 Carnaxide

Portugal

Seresto coleira 1,25  g +0,56  g para gatos e cães ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Portugal

Bayer Portugal, Lda.,

Rua Quinta do Pinheiro, 5,

2794-003 Carnaxide

Portugal

Seresto coleira 1,25  g +0,56  g para cães ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Portugal

Bayer Portugal, Lda.,

Rua Quinta do Pinheiro, 5,

2794-003 Carnaxide

Portugal

Seresto coleira 4,50  g +2,03  g para cães > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Romania

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 1.25 g + 0.56 g, zgardă antiparazitară pentru pisici şi câini ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Romania

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Foresto 4.50 g + 2.03 g, g zgardă antiparazitară pentru câini > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Slovakia

Bayer s.r.o., Siemensova 2717/4, 155 80 Praha 5,

Czech Republic

Foresto 1,25  g +0,56  g obojok pre macky a psy ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Slovakia

Bayer s.r.o., Siemensova 2717/4, 155 80 Praha 5,

Czech Republic

Foresto 4,50  g +2,03  g obojok pre psy > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Slovenia

Bayer d.o.o.,

Bravničarjeva 13

1000 Ljubljana

Slovenia

Foresto 1,25  g +0,56  g, ovratnica za mačke in pse ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Slovenia

Bayer d.o.o.,

Bravničarjeva 13

1000 Ljubljana

Slovenia

Foresto 4,50  g +2,03  g, ovratnica za pse > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Spain

Bayer Hispania, S.L.,

Av. Baix Lobregat, 3-5

08970 Sant Joan Despí

(Barcelona)

Spain

Seresto 1,25  g +0,56  g collar para perros ≤ 8 kg y gatos

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Spain

Bayer Hispania, S.L.,

Av. Baix Lobregat, 3-5

08970 Sant Joan Despí

(Barcelona)

Spain

Seresto 1,25  g +0,56  g collar para perros ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Spain

Bayer Hispania, S.L.,

Av. Baix Lobregat, 3-5

08970 Sant Joan Despí

(Barcelona)

Spain

Seresto 4,50  g +2,03  g collar para perros > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

Sweden

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet för katt och hund upp till 8 kg, 1,25  g +0,56  g halsband

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Sweden

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet. för hund upp till 8 kg 1,25  g +0,56  g halsband

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

Sweden

Bayer Animal Health GmbH,

51368 Leverkusen

Germany

Seresto vet för hund över 8 kg 4,50  g +2,03  g halsband

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

United Kingdom

Bayer plc,

400 South Oak Way

Green Park

Reading

Berkshire

RG2 6AD

United Kingdom

Seresto 1,25  +0,56 collar for cats

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

United Kingdom

Bayer plc,

400 South Oak Way

Green Park

Reading

Berkshire

RG2 6AD

United Kingdom

Seresto 1,25  +0,56 collar for dogs ≤ 8 kg

imidacloprid/

flumethrin

1.25 g imidacloprid/0.56 g flumethrin

Collar

Dogs

Cutaneous use

United Kingdom

Bayer plc,

400 South Oak Way

Green Park

Reading

Berkshire

RG2 6AD

United Kingdom

Seresto 4,50  +2,03 collar for dogs > 8 kg

imidacloprid/

flumethrin

4.50 g imidacloprid/2.03 g flumethrin

Collar

Dogs

Cutaneous use

---

ANNEX III

List of medicinal products and presentations

| Member State in EU/EEA | Marketing Authorisation holder | Invented name | INN + Strength | Pharmaceutical form | Route of Administration |
| --- | --- | --- | --- | --- | --- |
| Austria | G.L. Pharma Gmbh | Convulex | Sodium Valproate 500 mg/5 Ml | Solution For Injection/Infusion | Intravenous Use |
| Austria | G.L. Pharma Gmbh | Convulex | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Austria | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Austria | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Austria | G.L. Pharma Gmbh | Convulex | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Austria | G.L. Pharma Gmbh | Convulex | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Austria | G.L. Pharma Gmbh | Convulex | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Austria | G.L. Pharma Gmbh | Convulex Für Kinder | Sodium Valproate 50 mg/Ml | Syrup | Oral Use |
| Austria | sanofi-aventis GmbH | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Austria | sanofi-aventis GmbH | Depakine | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Austria | sanofi-aventis GmbH | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Austria | sanofi-aventis GmbH | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Austria | sanofi-aventis GmbH | Depakine Chronosphere | Valproic Acid 14.51 mg Sachet, Sodium Valproate 33.33 mg Sachet | Modified-Release Granules | Oral Use |
| Austria | sanofi-aventis GmbH | Depakine Chronosphere | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Modified-Release Granules | Oral Use |
| Austria | sanofi-aventis GmbH | Depakine Chronosphere | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Modified-Release Granules | Oral Use |
| Austria | G.L. Pharma Gmbh | Natriumvalproat G.L. | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Austria | G.L. Pharma Gmbh | Natriumvalproat G.L. | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Belgium | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule | Oral Use |
| Belgium | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule | Oral Use |
| Belgium | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Hard | Oral Use |
| Belgium | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Hard | Oral Use |
| Belgium | Sanofi Belgium | Depakine | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Belgium | Sanofi Belgium | Depakine | Sodium Valproate 60 mg/Ml | Syrup | Oral Use |
| Belgium | Sanofi Belgium | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Belgium | Sanofi Belgium | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Belgium | Sanofi Belgium | Depakine Enteric | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Belgium | Sanofi Belgium | Depakine Enteric | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Belgium | Sanofi Belgium | Depakine Enteric | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Belgium | Sanofi Belgium | Depakine I.V. | Sodium Valproate 400 mg Container | Powder And Solvent For Solution For Injection | Intravenous Use |
| Belgium | Sandoz N.V. | Valproate | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Belgium | Sandoz N.V. | Valproate | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Belgium | Mylan Bvba/Sprl | Valproate Mylan | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Belgium | Eurogenerics N.V./S.A. | Valproate Retard Eg | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Belgium | Eurogenerics N.V./S.A. | Valproate Retard Eg | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Belgium | Mylan Bvba/Sprl | Valproate Retard Mylan | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Belgium | Mylan Bvba/Sprl | Valproate Retard Mylan | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Bulgaria | Sanofi Bulgaria Eood | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Bulgaria | Sanofi Bulgaria Eood | Depakine | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Bulgaria | Sanofi Bulgaria Eood | Depakine | Sodium Valproate 57.64 mg/Ml | Syrup | Oral Use |
| Bulgaria | Sanofi Bulgaria Eood | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Bulgaria | Sanofi Bulgaria Eood | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Bulgaria | G.L. Pharma Gmbh | Kонвулекс хроно | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Bulgaria | G.L. Pharma Gmbh | конвулекс | Sodium Valproate 500 mg/5 Ml | Solution For Injection/Infusion | Intravenous Use |
| Bulgaria | G.L. Pharma Gmbh | конвулекс | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Bulgaria | G.L. Pharma Gmbh | конвулекс | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Bulgaria | G.L. Pharma Gmbh | конвулекс | Sodium Valproate 50 mg/Ml | Syrup | Oral Use |
| Bulgaria | G.L. Pharma Gmbh | конвулекс хроно | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Croatia | Sanofi-Aventis Croatia D.O.O. | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Croatia | Sanofi-Aventis Croatia D.O.O. | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Cyprus | Sanofi-Aventis Cyprus Ltd | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Cyprus | Remedica Ltd | Petilin | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Cyprus | Remedica Ltd | Petilin | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Cyprus | Remedica Ltd | Petilin | Sodium Valproate 200 mg/5 Ml | Syrup | Oral Use |
| Czech Republic | G.L. Pharma Gmbh | Convulex | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Czech Republic | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Czech Republic | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Czech Republic | G.L. Pharma Gmbh | Convulex | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Czech Republic | G.L. Pharma Gmbh | Convulex | Sodium Valproate 50 mg/Ml | Syrup | Oral Use |
| Czech Republic | G.L. Pharma Gmbh | Convulex Cr | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Czech Republic | G.L. Pharma Gmbh | Convulex Cr | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Czech Republic | Sanofi-Aventis Sro | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Czech Republic | Sanofi-Aventis Sro | Depakine | Sodium Valproate 57.64 mg/Ml | Syrup | Oral Use |
| Czech Republic | Sanofi-Aventis Sro | Depakine Chrono Secable | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Czech Republic | Sanofi-Aventis Sro | Depakine Chrono Secable | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Czech Republic | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Czech Republic | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Czech Republic | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Czech Republic | Desitin Arzneimittel Gmbh | Orfiril I.V. | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Czech Republic | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Czech Republic | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Czech Republic | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 1000 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Czech Republic | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Czech Republic | Ratiopharm Gmbh | Valproat | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Czech Republic | Ratiopharm Gmbh | Valproat | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Czech Republic | Sandoz Gmbh | Valproat Chrono Sandoz | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Czech Republic | Sandoz Gmbh | Valproat Chrono Sandoz | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Denmark | Orion Corporation | Delepsine | Sodium Valproate 100 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Denmark | Orion Corporation | Delepsine | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Denmark | Orion Corporation | Delepsine | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Denmark | Orion Corporation | Delepsine | Sodium Valproate 200 mg/Ml | Oral Drops, Solution | Oral Use |
| Denmark | Orion Corporation | Delepsine | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Denmark | Orion Corporation | Delepsine | Sodium Valproate 300 mg Suppository | Suppository | Rectal Use |
| Denmark | Orion Corporation | Delepsine Retard | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Denmark | Sanofi-Aventis Denmark A/S | Deprakine | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Denmark | Sanofi-Aventis Denmark A/S | Deprakine | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Denmark | Sanofi-Aventis Denmark A/S | Deprakine Retard | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Denmark | Sanofi-Aventis Denmark A/S | Deprakine Retard | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Denmark | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Denmark | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Denmark | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Denmark | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Denmark | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Denmark | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Denmark | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 1000 mg Container | Prolonged-Release Granules | Oral Use |
| Denmark | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 500 mg Container | Prolonged-Release Granules | Oral Use |
| Denmark | Desitin Arzneimittel Gmbh | Orfiril Retard | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Estonia | G.L. Pharma Gmbh | Convulex | Sodium Valproate 500 mg/5 Ml | Concentrate For Solution For Injection/Infusion | Intravenous Use |
| Estonia | G.L. Pharma Gmbh | Convulex | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Estonia | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Estonia | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Estonia | G.L. Pharma Gmbh | Convulex | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Estonia | G.L. Pharma Gmbh | Convulex | Sodium Valproate 50 mg/Ml | Syrup | Oral Use |
| Estonia | G.L. Pharma Gmbh | Convulex Retard | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Estonia | G.L. Pharma Gmbh | Convulex Retard | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Estonia | Sanofi-Aventis Estonia Oü | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Estonia | Sanofi-Aventis Estonia Oü | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Estonia | Sanofi-Aventis Estonia Oü | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Estonia | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Estonia | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Estonia | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Estonia | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Estonia | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Estonia | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Estonia | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 500 mg Container | Prolonged-Release Granules | Oral Use |
| Estonia | Desitin Arzneimittel Gmbh | Orfiril Saft | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Estonia | Sandoz Pharmaceuticals D.D. | Valproate Sodium Sandoz | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Finland | Orion Oyj | Absenor | Sodium Valproate 100 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Finland | Orion Oyj | Absenor | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Finland | Orion Oyj | Absenor | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Finland | Orion Oyj | Absenor | Sodium Valproate 200 mg/Ml | Oral Drops, Solution | Oral Use |
| Finland | Orion Oyj | Absenor | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Finland | Orion Oyj | Absenor | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Finland | Orion Oyj | Absenor | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Finland | Sanofi Oy | Deprakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Finland | Sanofi Oy | Deprakine | Sodium Valproate 100 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Finland | Sanofi Oy | Deprakine | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Finland | Sanofi Oy | Deprakine | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Finland | Sanofi Oy | Deprakine | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Finland | Sanofi Oy | Deprakine | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Finland | Sanofi Oy | Deprakine | Sodium Valproate 200 mg/Ml | Oral Drops, Solution | Oral Use |
| Finland | Sanofi Oy | Deprakine | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Finland | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Finland | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Finland | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Finland | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 500 mg Container | Prolonged-Release Granules | Oral Use |
| Finland | Sandoz A/S | Valproat Sandoz | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Finland | Sandoz A/S | Valproat Sandoz | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| France | Sanofi-Aventis France | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| France | Sanofi-Aventis France | Depakine | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| France | Sanofi-Aventis France | Depakine | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| France | Sanofi-Aventis France | Depakine | Sodium Valproate 200 mg/Ml | Oral Solution | Oral Use |
| France | Sanofi-Aventis France | Depakine | Sodium Valproate 57.64 mg/Ml | Syrup | Oral Use |
| France | Sanofi-Aventis France | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| France | Sanofi-Aventis France | Depakote | Valproate Semisodium 250 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| France | Sanofi-Aventis France | Depakote | Valproate Semisodium 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| France | Sanofi-Aventis France | Depamide | Valpromide 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| France | Sanofi-Aventis France | Micropakine L.P. | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Prolonged-Release Granules | Oral Use |
| France | Sanofi-Aventis France | Micropakine L.P. | Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet | Prolonged-Release Granules | Oral Use |
| France | Sanofi-Aventis France | Micropakine L.P. | Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet | Prolonged-Release Granules | Oral Use |
| France | Sanofi-Aventis France | Micropakine L.P. | Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet | Prolonged-Release Granules | Oral Use |
| France | Sanofi-Aventis France | Micropakine L.P. | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Prolonged-Release Granules | Oral Use |
| France | Laboratoire Aguettant | Valproate De Sodium Aguettant | Sodium Valproate 400 mg/4 Ml | Solution For Injection | Intravenous Use |
| France | Arrow Generiques | Valproate De Sodium Arrow | Sodium Valproate 200 mg/Ml | Oral Solution | Oral Use |
| France | Eg Labo Laboratoires Eurogenerics | Valproate De Sodium Eg L.P. | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| France | Arrow Generiques | Valproate De Sodium L.P Arrow | Sodium Valproate 500 mg Tablet | Film-Coated Tablet | Oral Use |
| France | Biogaran | Valproate De Sodium L.P. Biogaran | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| France | Sanofi-Aventis France | Valproate De Sodium Lp Zentiva | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| France | Mylan S.A.S | Valproate De Sodium Mylan | Sodium Valproate 500 mg Tablet | Modified-Release Tablet | Oral Use |
| France | Sandoz | Valproate De Sodium Sandoz | Sodium Valproate 500 mg Tablet | Modified-Release Tablet | Oral Use |
| France | Ratiopharm Gmbh | Valproate De Sodium Teva | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| France | Sanofi-Aventis France | Valproate De Sodium Zentiva | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| France | Sanofi-Aventis France | Valproate De Sodium Zentiva | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| France | Sanofi-Aventis France | Valproate De Sodium Zentiva | Sodium Valproate 200 mg/Ml | Oral Solution | Oral Use |
| Germany | G.L. Pharma Gmbh | Convulex | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Germany | G.L. Pharma Gmbh | Convulex | Sodium Valproate 300 mg Capsule | Prolonged-Release Tablet | Oral Use |
| Germany | G.L. Pharma Gmbh | Convulex | Sodium Valproate 500 mg Capsule | Prolonged-Release Tablet | Oral Use |
| Germany | G.L. Pharma Gmbh | Convulex® | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule | Oral Use |
| Germany | G.L. Pharma Gmbh | Convulex® | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule | Oral Use |
| Germany | G.L. Pharma Gmbh | Convulex® | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule | Oral Use |
| Germany | Sanofi-Aventis Deutschland Gmbh | Ergenyl | Sodium Valproate 400 mg Container | Powder And Solvent For Solution For Injection | Intravenous Use |
| Germany | Sanofi-Aventis Deutschland Gmbh | Ergenyl | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Germany | Sanofi-Aventis Deutschland Gmbh | Ergenyl | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Sanofi-Aventis Deutschland Gmbh | Ergenyl | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Sanofi-Aventis Deutschland Gmbh | Ergenyl | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Sanofi-Aventis Deutschland Gmbh | Ergenyl | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Germany | Sanofi-Aventis Deutschland Gmbh | Ergenyl Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Sanofi-Aventis Deutschland Gmbh | Ergenyl Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | (Art 57) | Espa-Valep Retard | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Aristo Pharma Gmbh (Art 57) | Espa-Valept | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Aristo Pharma Gmbh (Art 57) | Espa-Valept | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Aristo Pharma Gmbh (Art 57) | Espa-Valept Retard | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Riemser Pharma Gmbh | Leptilan | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Riemser Pharma Gmbh | Leptilan | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Riemser Pharma Gmbh | Leptilan | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Aristo Pharma Gmbh (Art 57) | Natriumvalproat Aristo | Sodium Valproate 300 mg G | Oral Drops, Solution | Oral Use |
| Germany | Hexal Ag | Natriumvalproat Hexal | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 1000 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Orfiril Saft | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Germany | Iip — Institut Für Industrielle Pharmazie Forschungs- Und Entwicklungsgesellschaft Mbh | Valhel Pr | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Iip — Institut Für Industrielle Pharmazie Forschungs- Und Entwicklungsgesellschaft Mbh | Valhel Pr | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Aliud Pharma Gmbh | Valpro | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Betapharm Arzneimittel Gmbh | Valpro | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Aliud Pharma Gmbh | Valpro Al | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Betapharm Arzneimittel Gmbh | Valpro Beta | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Betapharm Arzneimittel Gmbh | Valpro Beta | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Betapharm Arzneimittel Gmbh | Valpro Beta | Sodium Valproate 300 mg/Ml | Oral Drops, Solution | Oral Use |
| Germany | Betapharm Arzneimittel Gmbh | Valpro Chrono | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Betapharm Arzneimittel Gmbh | Valpro Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Tad Pharma Gmbh | Valpro Tad | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Germany | Tad Pharma Gmbh | Valpro Tad | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Capsule | Oral Use |
| Germany | Tad Pharma Gmbh | Valpro Tad | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Capsule | Oral Use |
| Germany | Abz-Pharma Gmbh | Valproat | Sodium Valproate 150 mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Abz-Pharma Gmbh | Valproat | Valproic Acid 145 mg G, Sodium Valproate 333 mg G | Prolonged-Release Tablet | Oral Use |
| Germany | Abz-Pharma Gmbh | Valproat | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Ratiopharm Gmbh | Valproat | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Ratiopharm Gmbh | Valproat | Valproic Acid 87 mg G, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Stadapharm Gmbh | Valproat | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Stadapharm Gmbh | Valproat | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | 1 A Pharma Gmbh | Valproat 1 A Pharma | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | 1 A Pharma Gmbh | Valproat 1 A Pharma | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | 1 A Pharma Gmbh | Valproat 1 A Pharma | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | 1 A Pharma Gmbh | Valproat 1 A Pharma | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | 1 A Pharma Gmbh | Valproat 1 A Pharma | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Aristo Pharma Gmbh (Art 57) | Valproat Aristo | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Aristo Pharma Gmbh (Art 57) | Valproat Aristo | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Abz-Pharma Gmbh | Valproat Chrono | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Abz-Pharma Gmbh | Valproat Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Valproat Chrono | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Desitin Arzneimittel Gmbh | Valproat Chrono | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Glenmark Pharmaceuticals Europe Limited | Valproat Chrono | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Glenmark Pharmaceuticals Europe Limited | Valproat Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Winthrop Arzneimittel Gmbh | Valproat Chrono | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Winthrop Arzneimittel Gmbh | Valproat Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Hexal Ag | Valproat Chrono Hexal | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Hexal Ag | Valproat Chrono Hexal | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Germany | Hexal Ag | Valproat Hexal | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Hexal Ag | Valproat Hexal | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Hexal Ag | Valproat Hexal | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Germany | Neuraxpharm Arzneimittel Gmbh | Valproat Neuraxpharm | Sodium Valproate 150 mg Units | Gastro-Resistant Tablet | Oral Use |
| Germany | Neuraxpharm Arzneimittel Gmbh | Valproat Neuraxpharm | Sodium Valproate 300 mg Units | Gastro-Resistant Tablet | Oral Use |
| Germany | Neuraxpharm Arzneimittel Gmbh | Valproat Neuraxpharm | Sodium Valproate 600 mg Units | Gastro-Resistant Tablet | Oral Use |
| Germany | Neuraxpharm Arzneimittel Gmbh | Valproat Neuraxpharm | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Germany | Neuraxpharm Arzneimittel Gmbh | Valproat Neuraxpharm | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Germany | Neuraxpharm Arzneimittel Gmbh | Valproat Neuraxpharm | Sodium Valproate 300 mg Units | Prolonged-Release Tablet | Oral Use |
| Germany | Neuraxpharm Arzneimittel Gmbh | Valproat Neuraxpharm | Sodium Valproate 500 mg Units | Prolonged-Release Tablet | Oral Use |
| Germany | Orion Corporation | Valproat Orion | Sodium Valproate 300 mg Tablet | Tablet | Oral Use |
| Germany | Orion Corporation | Valproat Orion | Sodium Valproate 500 mg Tablet | Tablet | Oral Use |
| Germany | Abz-Pharma Gmbh | Valproat-Ct | Sodium Valproate 300 mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Abz-Pharma Gmbh | Valproat-Ct | Sodium Valproate 600 mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Ratiopharm Gmbh | Valproinsäure | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Germany | Ratiopharm Gmbh | Valproinsäure Ratiopharm | Sodium Valproate 150 mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Ratiopharm Gmbh | Valproinsäure Ratiopharm | Sodium Valproate 300 mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Ratiopharm Gmbh | Valproinsäure Ratiopharm | Sodium Valproate 600 mg Tablet | Film-Coated Tablet | Oral Use |
| Greece | Sanofi-Aventis Aebe | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Greece | Sanofi-Aventis Aebe | Depakine | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Greece | Sanofi-Aventis Aebe | Depakine | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Greece | Sanofi-Aventis Aebe | Depakine | Sodium Valproate 200 mg/Ml | Oral Solution | Oral Use |
| Greece | Sanofi-Aventis Aebe | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Greece | Sanofi-Aventis Aebe | Depakine Chronosphere | Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet | Modified-Release Granules | Oral Use |
| Greece | Sanofi-Aventis Aebe | Depakine Chronosphere | Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet | Modified-Release Granules | Oral Use |
| Greece | Sanofi-Aventis Aebe | Depakine Chronosphere | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Modified-Release Granules | Oral Use |
| Greece | Demo Abee | Hexaquin | Sodium Valproate 400 mg Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | G.L. Pharma Gmbh | Convulex | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Hungary | G.L. Pharma Gmbh | Convulex | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Hungary | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Hungary | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Hungary | G.L. Pharma Gmbh | Convulex | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Hungary | G.L. Pharma Gmbh | Convulex | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Hungary | G.L. Pharma Gmbh | Convulex | Valproic Acid 43.38 mg/Ml | Syrup | Oral Use |
| Hungary | Sanofi-Aventis Zrt | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Hungary | Sanofi-Aventis Zrt | Depakine | Valproic Acid 50 mg/Ml | Syrup | Oral Use |
| Hungary | Sanofi-Aventis Zrt | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Hungary | Sanofi-Aventis Zrt | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Iceland | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Iceland | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Iceland | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Iceland | Desitin Arzneimittel Gmbh | Orfiril Retard | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim | Sodium Valproate 40 mg/Ml | Oral Solution | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim | Sodium Valproate 40 mg/Ml | Syrup | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim | Sodium Valproate 100 mg Tablet | Tablet | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim Chrono | Valproic Acid 58 mg Tablet, Sodium Valproate 133.2 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim Chronosphere | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Prolonged-Release Granules | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim Chronosphere | Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet | Prolonged-Release Granules | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim Chronosphere | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Prolonged-Release Granules | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim Enteric | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Ireland | Sanofi-Aventis Ireland Ltd T/A SANOFI | Epilim Enteric | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Eg S.P.A. | Acido Valproico E Sodio Valproato Eg | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Italy | Eg S.P.A. | Acido Valproico E Sodio Valproato Eg | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Italy | Ratiopharm Gmbh | Acido Valproico E Sodio Valproato Ratiopharm | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Italy | Ratiopharm Gmbh | Acido Valproico E Sodio Valproato Ratiopharm | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Italy | Ratiopharm Gmbh | Acido Valproico E Sodio Valproato Ratiopharm Ratiopharm | Valproic Acid 145 mg G, Sodium Valproate 333 mg G | Prolonged-Release Tablet | Oral Use |
| Italy | Sandoz S.P.A. | Acido Valproico Sandoz | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Italy | Sandoz S.P.A. | Acido Valproico Sandoz | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Italy | Sanofi Spa | Depakin | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Italy | Sanofi Spa | Depakin | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Sanofi Spa | Depakin | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Sanofi Spa | Depakin | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Modified-Release Granules | Oral Use |
| Italy | Sanofi Spa | Depakin | Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet | Modified-Release Granules | Oral Use |
| Italy | Sanofi Spa | Depakin | Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet | Modified-Release Granules | Oral Use |
| Italy | Sanofi Spa | Depakin | Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet | Modified-Release Granules | Oral Use |
| Italy | Sanofi Spa | Depakin | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Modified-Release Granules | Oral Use |
| Italy | Sanofi Spa | Depakin | Sodium Valproate 200 mg/Ml | Oral Solution | Oral Use |
| Italy | Sanofi Spa | Depakin Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Italy | Sanofi Spa | Depakin Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Italy | Alfasigma S.p.A. | Depamag | Valproate Magnesium 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Alfasigma S.p.A. | Depamag | Valproate Magnesium 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Alfasigma S.p.A. | Depamag | Valproate Magnesium 10000 mg/100 Ml | Oral Solution | Oral Use |
| Italy | Sanofi Spa | Depamide | Valpromide 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Zentiva Italia Srl | Sodio Valproato | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Zentiva Italia Srl | Sodio Valproato | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Zentiva Italia Srl | Sodio Valproato | Sodium Valproate 200 mg/Ml | Oral Solution | Oral Use |
| Italy | Zentiva Italia Srl | Sodio Valproato | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Italy | Zentiva Italia Srl | Sodio Valproato | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Latvia | Orion Corporation | Absenor | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Latvia | G.L. Pharma Gmbh | Convulex | Sodium Valproate 500 mg/5 Ml | Concentrate For Solution For Injection/Infusion | Intravenous Use |
| Latvia | G.L. Pharma Gmbh | Convulex | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Latvia | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Latvia | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Latvia | G.L. Pharma Gmbh | Convulex | Sodium Valproate 50 mg/Ml | Syrup | Oral Use |
| Latvia | G.L. Pharma Gmbh | Convulex® | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Latvia | G.L. Pharma Gmbh | Convulex® Retard | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Latvia | G.L. Pharma Gmbh | Convulex® Retard | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Latvia | Sanofi-Aventis Latvia Sia | Depakine | Sodium Valproate 57.64 mg/Ml | Syrup | Oral Use |
| Latvia | Sanofi-Aventis Latvia Sia | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Latvia | Sanofi-Aventis Latvia Sia | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Lithuania | Orion Corporation | Absenor | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Lithuania | G.L. Pharma Gmbh | Convulex | Sodium Valproate 100 mg/Ml | Solution For Injection/Infusion | Intravenous Use |
| Lithuania | G.L. Pharma Gmbh | Convulex | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Lithuania | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Lithuania | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Lithuania | G.L. Pharma Gmbh | Convulex | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Lithuania | G.L. Pharma Gmbh | Convulex | Sodium Valproate 50 mg/Ml | Syrup | Oral Use |
| Lithuania | G.L. Pharma Gmbh | Convulex Retard | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Lithuania | G.L. Pharma Gmbh | Convulex Retard | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Lithuania | Uab ‘Sanofi-Aventis Lietuva’ | Depakine | Sodium Valproate 57.64 mg/Ml | Syrup | Oral Use |
| Lithuania | Uab ‘Sanofi-Aventis Lietuva’ | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Lithuania | Uab ‘Sanofi-Aventis Lietuva’ | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Lithuania | Uab ‘Sanofi-Aventis Lietuva’ | Depakine Chronosphere | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Modified-Release Granules | Oral Use |
| Lithuania | Uab ‘Sanofi-Aventis Lietuva’ | Depakine Chronosphere | Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet | Modified-Release Granules | Oral Use |
| Lithuania | Uab ‘Sanofi-Aventis Lietuva’ | Depakine Chronosphere | Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet | Modified-Release Granules | Oral Use |
| Lithuania | Uab ‘Sanofi-Aventis Lietuva’ | Depakine Chronosphere | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Modified-Release Granules | Oral Use |
| Lithuania | Sandoz Pharmaceuticals D.D. | Valproate Sodium Sandoz | Sodium Valproate 500 mg Tablet | Modified-Release Tablet | Oral Use |
| Luxembourg | Sanofi Belgium | Depakine | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Luxembourg | Sanofi Belgium | Depakine | Sodium Valproate 60 mg/Ml | Syrup | Oral Use |
| Luxembourg | Sanofi Belgium | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Luxembourg | Sanofi Belgium | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Luxembourg | Sanofi Belgium | Depakine Enteric | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Luxembourg | Sanofi Belgium | Depakine Enteric | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Luxembourg | Sanofi Belgium | Depakine Enteric | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Luxembourg | Sanofi Belgium | Depakine I.V. | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Luxembourg | Ratiopharm Gmbh | Valproat | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Luxembourg | Ratiopharm Gmbh | Valproat Ratiopharm | Valproic Acid 145 mg G, Sodium Valproate 333 mg G | Prolonged-Release Tablet | Oral Use |
| Luxembourg | Eurogenerics N.V./S.A. | Valproate Retard Eg | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Luxembourg | Eurogenerics N.V./S.A. | Valproate Retard Eg | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Luxembourg | Mylan Bvba/Sprl | Valproate Retard Mylan | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Luxembourg | Mylan Bvba/Sprl | Valproate Retard Mylan | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Malta | Sanofi Malta Ltd | Epilim | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Malta | Sanofi Malta Ltd | Epilim | Sodium Valproate 200 mg/5 Ml | Oral Solution | Oral Use |
| Malta | Sanofi Malta Ltd | Epilim Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Malta | Sanofi Malta Ltd | Epilim Chrono | Valproic Acid 58 mg Tablet, Sodium Valproate 133.2 mg Tablet | Modified-Release Tablet | Oral Use |
| Malta | Sanofi Malta Ltd | Epilim Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Malta | Wockhardt Uk Ltd | Sodium Valproate Wockhardt Uk | Sodium Valproate 100 mg/Ml | Solution For Injection/Infusion | Intravenous Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine | Sodium Valproate 40 mg/Ml | Syrup | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Chronosphere | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Modified-Release Granules | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Chronosphere | Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet | Modified-Release Granules | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Chronosphere | Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet | Modified-Release Granules | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Chronosphere | Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet | Modified-Release Granules | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Chronosphere | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Modified-Release Granules | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Enteric | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Enteric | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Netherlands | Sanofi-Aventis Netherlands B.V. | Depakine Enteric | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Netherlands | Apotex Europe B.V. | Natriumvalproaat Apotex | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Netherlands | Apotex Europe Bv | Natriumvalproaat Apotex | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Netherlands | Apotex Europe Bv | Natriumvalproaat Apotex | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Netherlands | Apotex Europe Bv | Natriumvalproaat Apotex | Sodium Valproate 300 mg/5 Ml | Oral Solution | Oral Use |
| Netherlands | Teva Nederland B.V. | Natriumvalproaat Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Netherlands | Centrafarm B.V. | Natriumvalproaat Chrono Cf | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Netherlands | Centrafarm B.V. | Natriumvalproaat Chrono Cf | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Netherlands | Sandoz B.V. | Natriumvalproaat Chrono Sandoz | Sodium Valproate 300 mg Tablet | Modified-Release Tablet | Oral Use |
| Netherlands | Sandoz B.V. | Natriumvalproaat Chrono Sandoz | Sodium Valproate 500 mg Tablet | Modified-Release Tablet | Oral Use |
| Netherlands | Sandoz B.V. | Natriumvalproaat Sandoz | Sodium Valproate 300 mg Tablet | Modified-Release Tablet | Oral Use |
| Netherlands | Sandoz B.V. | Natriumvalproaat Sandoz | Sodium Valproate 500 mg Tablet | Modified-Release Tablet | Oral Use |
| Netherlands | Teva Nederland B.V. | Natriumvalproaat Teva | Valproic Acid 145 mg G, Sodium Valproate 333 mg G | Prolonged-Release Tablet | Oral Use |
| Netherlands | Pharmachemie B.V | Orfiril | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Netherlands | Pharmachemie B.V | Orfiril Cr | Sodium Valproate 300 mg Capsule | Modified-Release Capsule, Hard | Oral Use |
| Netherlands | Pharmachemie B.V | Orfiril Cr | Sodium Valproate 1000 mg Sachet | Modified-Release Granules | Oral Use |
| Netherlands | Pharmachemie B.V | Orfiril Cr | Sodium Valproate 500 mg Sachet | Modified-Release Granules | Oral Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule | Oral Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 300 mg | Prolonged-Release Capsule | Oral Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 1000 mg Container | Prolonged-Release Granules | Oral Use |
| Norway | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 500 mg Container | Prolonged-Release Granules | Oral Use |
| Poland | Orion Corporation | Absenor | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Poland | Orion Corporation | Absenor | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Poland | G.L. Pharma Gmbh | Convival Chrono | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Poland | G.L. Pharma Gmbh | Convulex | Valproic Acid 150 mg Capsule | Capsule, Soft | Oral Use |
| Poland | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Capsule, Soft | Oral Use |
| Poland | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Capsule, Soft | Oral Use |
| Poland | G.L. Pharma Gmbh | Convulex | Sodium Valproate 50 mg/Ml | Syrup | Oral Use |
| Poland | Sanofi-Aventis France | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Poland | Sanofi-Aventis France | Depakine | Sodium Valproate 40 mg/Ml | Syrup | Oral Use |
| Poland | Sanofi-Aventis Sp Z.O.O. | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Poland | Sanofi-Aventis Sp Z.O.O. | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Poland | Sanofi-Aventis Sp Z.O.O. | Depakine Chronosphere | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Modified-Release Granules | Oral Use |
| Poland | Sanofi-Aventis Sp Z.O.O. | Depakine Chronosphere | Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet | Modified-Release Granules | Oral Use |
| Poland | Sanofi-Aventis Sp Z.O.O. | Depakine Chronosphere | Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet | Modified-Release Granules | Oral Use |
| Poland | Sanofi-Aventis Sp Z.O.O. | Depakine Chronosphere | Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet | Modified-Release Granules | Oral Use |
| Poland | Sanofi-Aventis Sp Z.O.O. | Depakine Chronosphere | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Modified-Release Granules | Oral Use |
| Poland | Pharmaswiss česká Republika S.R.O. | Dipromal | Valproate Magnesium 200 mg Tablet | Film-Coated Tablet | Oral Use |
| Poland | Sandoz Gmbh | Valprolek | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Poland | Sandoz Gmbh | Valprolek | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Generis Farmacêutica, S.A. | ácido Valpróico Generis | Valproic Acid 400 mg/4 Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Generis Farmacêutica, S.A. | ácido Valpróico Generis | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Generis Farmacêutica, S.A. | ácido Valpróico Generis | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Sandoz Farmacêutica Lda. | ácido Valpróico Sandoz | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Sandoz Farmacêutica Lda. | ácido Valpróico Sandoz | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine | Sodium Valproate 200 mg/Ml | Oral Solution | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine | Sodium Valproate 40 mg/Ml | Syrup | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chrono 300 | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chrono 300 | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chrono 500 | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chronosphere | Valproic Acid 14.51 mg Sachet, Sodium Valproate 33.33 mg Sachet | Modified-Release Granules | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chronosphere | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Modified-Release Granules | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chronosphere | Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet | Modified-Release Granules | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chronosphere | Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet | Modified-Release Granules | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chronosphere | Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet | Modified-Release Granules | Oral Use |
| Portugal | Sanofi — Produtos Farmaceuticos Lda | Depakine Chronosphere | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Modified-Release Granules | Oral Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil | Sodium Valproate 200 mg Tablet | Coated Tablet | Oral Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil | Sodium Valproate 200 mg/Ml | Oral Solution | Oral Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule | Oral Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule | Oral Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil | Sodium Valproate 1000 mg Sachet | Prolonged-Release Granules | Oral Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil | Sodium Valproate 500 mg Sachet | Prolonged-Release Granules | Oral Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil-R | Valproate Semisodium 269.1 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Portugal | Tecnifar, Indústria Técnica Farmacêutica, Sa | Diplexil-R | Valproate Semisodium 538.2 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Portugal | Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda | Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Portugal | Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda | Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Romania | Lannacher Heilmittel Ges.M.B.H., | Convulex | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Romania | Lannacher Heilmittel Ges.M.B.H., | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Romania | Lannacher Heilmittel Ges.M.B.H., | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Romania | Sanofi-Aventis France | Depakine | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Romania | Sanofi-Aventis France | Depakine | Sodium Valproate 57.64 mg/Ml | Syrup | Oral Use |
| Romania | Sanofi-Aventis France | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Romania | Sanofi-Aventis France | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Romania | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 300 mg/5 Ml | Oral Solution | Oral Use |
| Romania | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Romania | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Romania | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 1000 mg Sachet | Prolonged-Release Granules In Sachet | Oral Use |
| Romania | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 500 mg Sachet | Prolonged-Release Granules In Sachet | Oral Use |
| Romania | Arena Group S.A | Valepil | Sodium Valproate 200 mg/5 Ml | Syrup | Oral Use |
| Slovakia | G.L. Pharma Gmbh | Convulex | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Slovakia | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Slovakia | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| Slovakia | G.L. Pharma Gmbh | Convulex | Sodium Valproate 300 mg/Ml | Oral Solution | Oral Use |
| Slovakia | G.L. Pharma Gmbh | Convulex | Sodium Valproate 50 mg/Ml | Syrup | Oral Use |
| Slovakia | G.L. Pharma Gmbh | Convulex Cr | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Slovakia | Sanofi-Aventis Slovakia Sro | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Slovakia | Sanofi-Aventis Slovakia Sro | Depakine | Sodium Valproate 57.64 mg/Ml | Syrup | Oral Use |
| Slovakia | Sanofi-Aventis Slovakia Sro | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Slovakia | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| Slovakia | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Slovakia | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Slovakia | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 600 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Slovakia | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule | Oral Use |
| Slovakia | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule | Oral Use |
| Slovakia | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 1000 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Slovakia | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Slovakia | Ratiopharm Gmbh | Valpro | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Slovakia | Sandoz Pharmaceuticals D.D. | Valproát Chrono Sandoz | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Slovakia | Sandoz Pharmaceuticals D.D. | Valproát Chrono Sandoz | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Slovenia | Sanofi-Aventis D.O.O. | Depakine Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Slovenia | Sanofi-Aventis D.O.O. | Depakine Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Spain | G.E.S. Genéricos Españoles Laboratorio, S.A. | ácido Valproico G.E.S | Sodium Valproate 400 mg Vial | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Sanofi-Aventis, S.A. | Depakine | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Spain | Sanofi-Aventis, S.A. | Depakine | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Spain | Sanofi-Aventis, S.A. | Depakine | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Spain | Sanofi-Aventis, S.A. | Depakine | Sodium Valproate 200 mg/Ml | Oral Solution | Oral Use |
| Spain | Sanofi-Aventis, S.A. | Depakine Crono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Spain | Sanofi-Aventis, S.A. | Depakine Crono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Spain | Sanofi-Aventis, S.A. | Depakine Crono | Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Spain | Sanofi-Aventis, S.A. | Depakine Crono | Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Sweden | Orion Corporation | Absenor | Sodium Valproate 100 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Sweden | Orion Corporation | Absenor | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Sweden | Orion Corporation | Absenor | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Sweden | Orion Corporation | Absenor | Sodium Valproate 200 mg/Ml | Oral Drops, Solution | Oral Use |
| Sweden | Orion Corporation | Absenor | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Sweden | Orion Corporation | Absenor Depot | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Sweden | Orion Corporation | Absenor Depot | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| Sweden | Sanofi Ab | Ergenyl | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| Sweden | Sanofi Ab | Ergenyl | Sodium Valproate 100 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Sweden | Sanofi Ab | Ergenyl | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Sweden | Sanofi Ab | Ergenyl | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Sweden | Sanofi Ab | Ergenyl | Sodium Valproate 200 mg/Ml | Oral Drops, Solution | Oral Use |
| Sweden | Sanofi Ab | Ergenyl | Sodium Valproate 60 mg/Ml | Oral Solution | Oral Use |
| Sweden | Sanofi Ab | Ergenyl Retard | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Modified-Release Granules | Oral Use |
| Sweden | Sanofi Ab | Ergenyl Retard | Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet | Modified-Release Granules | Oral Use |
| Sweden | Sanofi Ab | Ergenyl Retard | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Modified-Release Granules | Oral Use |
| Sweden | Sanofi Ab | Ergenyl Retard | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Modified-Release Tablet | Oral Use |
| Sweden | Sanofi Ab | Ergenyl Retard | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Modified-Release Tablet | Oral Use |
| Sweden | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 150 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Sweden | Desitin Arzneimittel Gmbh | Orfiril | Sodium Valproate 300 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| Sweden | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Sweden | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| Sweden | Desitin Arzneimittel Gmbh | Orfiril Long | Sodium Valproate 500 mg Container | Prolonged-Release Granules | Oral Use |
| United Kingdom | G.L. Pharma Gmbh | Convulex | Valproic Acid 150 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| United Kingdom | G.L. Pharma Gmbh | Convulex | Valproic Acid 300 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| United Kingdom | G.L. Pharma Gmbh | Convulex | Valproic Acid 500 mg Capsule | Gastro-Resistant Capsule, Soft | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Depakote | Valproate Semisodium 269.1 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Depakote | Valproate Semisodium 538.2 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim | Sodium Valproate 400 mg/Ml | Powder And Solvent For Solution For Injection | Intravenous Use |
| United Kingdom | Aventis Pharma Ltd | Epilim | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim | Sodium Valproate 40 mg/Ml | Oral Solution | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim | Sodium Valproate 40 mg/Ml | Syrup | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim | Sodium Valproate 100 mg Tablet | Tablet | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim Chrono | Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet | Prolonged-Release Tablet | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim Chrono | Valproic Acid 58 mg Tablet, Sodium Valproate 133.2 mg Tablet | Prolonged-Release Tablet | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim Chrono | Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet | Prolonged-Release Tablet | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim Chronosphere | Valproic Acid 14.51 mg Sachet, Sodium Valproate 33.33 mg Sachet | Modified-Release Granules | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim Chronosphere | Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet | Modified-Release Granules | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim Chronosphere | Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet | Modified-Release Granules | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim Chronosphere | Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet | Modified-Release Granules | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim Chronosphere | Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet | Modified-Release Granules | Oral Use |
| United Kingdom | Aventis Pharma Ltd | Epilim Chronosphere | Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet | Modified-Release Granules | Oral Use |
| United Kingdom | Desitin Arzneimittel Gmbh | Episenta | Sodium Valproate 100 mg/Ml | Solution For Injection | Intravenous Use |
| United Kingdom | Desitin Arzneimittel Gmbh | Episenta | Sodium Valproate 150 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| United Kingdom | Desitin Arzneimittel Gmbh | Episenta | Sodium Valproate 300 mg Capsule | Prolonged-Release Capsule, Hard | Oral Use |
| United Kingdom | Desitin Arzneimittel Gmbh | Episenta | Sodium Valproate 1000 mg Sachet | Prolonged-Release Granules | Oral Use |
| United Kingdom | Desitin Arzneimittel Gmbh | Episenta | Sodium Valproate 500 mg Sachet | Prolonged-Release Granules | Oral Use |
| United Kingdom | G.L. Pharma Gmbh | Epival Cr | Sodium Valproate 300 mg Tablet | Prolonged-Release Tablet | Oral Use |
| United Kingdom | G.L. Pharma Gmbh | Epival Cr | Sodium Valproate 500 mg Tablet | Prolonged-Release Tablet | Oral Use |
| United Kingdom | Norton Healthcare Ltd T/A Ivax Pharmaceuticals Uk | Kentlim Opd | Sodium Valproate Bp 200 mg | Oral Solution | Oral Use |
| United Kingdom | Winthrop Pharmaceuticals Uk Ltd | Sodium Valproate | Sodium Valproate 40 mg/Ml | Oral Solution | Oral Use |
| United Kingdom | Norton Healthcare Ltd T/A Ivax Pharmaceuticals Uk | Sodium Valproate Ivax | Sodium Valproate 200 mg/5 Ml | Oral Solution | Oral Use |
| United Kingdom | Noridem Enterprises Ltd | Sodium Valproate Noridem Enterprises | Sodium Valproate 400 mg Vial | Powder And Solvent For Solution For Injection/Infusion | Intravenous Use |
| United Kingdom | Teva Uk Limited | Sodium Valproate Teva | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Teva Uk Limited | Sodium Valproate Teva | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Winthrop Pharmaceuticals Uk Ltd | Sodium Valproate Winthrop | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Winthrop Pharmaceuticals Uk Ltd | Sodium Valproate Winthrop | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Wockhardt Uk Ltd | Sodium Valproate Wockhardt | Sodium Valproate 100 mg/Ml | Solution For Injection/Infusion | Intravenous Use |
| United Kingdom | Wockhardt Uk Ltd | Sodium Valproate Wockhardt | Sodium Valproate 200 mg | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Wockhardt Uk Ltd | Sodium Valproate Wockhardt | Sodium Valproate 200 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Wockhardt Uk Ltd | Sodium Valproate Wockhardt | Sodium Valproate 500 mg Tablet | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Wockhardt Uk Ltd | Sodium Valproate Wockhardt | Sodium Valproate 200 mg/5 Ml | Oral Solution | Oral Use |
| United Kingdom | Wockhardt Uk Ltd | Sodium Valproate Wockhardt Uk | Sodium Valproate 500 mg | Gastro-Resistant Tablet | Oral Use |
| United Kingdom | Norton Healthcare Ltd T/A Ivax Pharmaceuticals Uk | Valpal | Sodium Valproate 200 mg/5 Ml | Oral Solution | Oral Use |

Member State in EU/EEA

Marketing Authorisation holder

Invented name

INN + Strength

Pharmaceutical form

Route of Administration

Austria

G.L. Pharma Gmbh

Convulex

Sodium Valproate 500 mg/5 Ml

Solution For Injection/Infusion

Intravenous Use

Austria

G.L. Pharma Gmbh

Convulex

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Austria

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Austria

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Austria

G.L. Pharma Gmbh

Convulex

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Austria

G.L. Pharma Gmbh

Convulex

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Austria

G.L. Pharma Gmbh

Convulex

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Austria

G.L. Pharma Gmbh

Convulex Für Kinder

Sodium Valproate 50 mg/Ml

Syrup

Oral Use

Austria

sanofi-aventis GmbH

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Austria

sanofi-aventis GmbH

Depakine

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Austria

sanofi-aventis GmbH

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Austria

sanofi-aventis GmbH

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Austria

sanofi-aventis GmbH

Depakine Chronosphere

Valproic Acid 14.51 mg Sachet, Sodium Valproate 33.33 mg Sachet

Modified-Release Granules

Oral Use

Austria

sanofi-aventis GmbH

Depakine Chronosphere

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Modified-Release Granules

Oral Use

Austria

sanofi-aventis GmbH

Depakine Chronosphere

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Modified-Release Granules

Oral Use

Austria

G.L. Pharma Gmbh

Natriumvalproat G.L.

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Austria

G.L. Pharma Gmbh

Natriumvalproat G.L.

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Belgium

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule

Oral Use

Belgium

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule

Oral Use

Belgium

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Hard

Oral Use

Belgium

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Hard

Oral Use

Belgium

Sanofi Belgium

Depakine

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Belgium

Sanofi Belgium

Depakine

Sodium Valproate 60 mg/Ml

Syrup

Oral Use

Belgium

Sanofi Belgium

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Belgium

Sanofi Belgium

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Belgium

Sanofi Belgium

Depakine Enteric

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Belgium

Sanofi Belgium

Depakine Enteric

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Belgium

Sanofi Belgium

Depakine Enteric

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Belgium

Sanofi Belgium

Depakine I.V.

Sodium Valproate 400 mg Container

Powder And Solvent For Solution For Injection

Intravenous Use

Belgium

Sandoz N.V.

Valproate

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Belgium

Sandoz N.V.

Valproate

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Belgium

Mylan Bvba/Sprl

Valproate Mylan

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Belgium

Eurogenerics N.V./S.A.

Valproate Retard Eg

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Belgium

Eurogenerics N.V./S.A.

Valproate Retard Eg

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Belgium

Mylan Bvba/Sprl

Valproate Retard Mylan

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Belgium

Mylan Bvba/Sprl

Valproate Retard Mylan

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Bulgaria

Sanofi Bulgaria Eood

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Bulgaria

Sanofi Bulgaria Eood

Depakine

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Bulgaria

Sanofi Bulgaria Eood

Depakine

Sodium Valproate 57.64 mg/Ml

Syrup

Oral Use

Bulgaria

Sanofi Bulgaria Eood

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Bulgaria

Sanofi Bulgaria Eood

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Bulgaria

G.L. Pharma Gmbh

Kонвулекс хроно

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Bulgaria

G.L. Pharma Gmbh

конвулекс

Sodium Valproate 500 mg/5 Ml

Solution For Injection/Infusion

Intravenous Use

Bulgaria

G.L. Pharma Gmbh

конвулекс

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Bulgaria

G.L. Pharma Gmbh

конвулекс

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Bulgaria

G.L. Pharma Gmbh

конвулекс

Sodium Valproate 50 mg/Ml

Syrup

Oral Use

Bulgaria

G.L. Pharma Gmbh

конвулекс хроно

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Croatia

Sanofi-Aventis Croatia D.O.O.

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Croatia

Sanofi-Aventis Croatia D.O.O.

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Cyprus

Sanofi-Aventis Cyprus Ltd

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Cyprus

Remedica Ltd

Petilin

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

Cyprus

Remedica Ltd

Petilin

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Cyprus

Remedica Ltd

Petilin

Sodium Valproate 200 mg/5 Ml

Syrup

Oral Use

Czech Republic

G.L. Pharma Gmbh

Convulex

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Czech Republic

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Czech Republic

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Czech Republic

G.L. Pharma Gmbh

Convulex

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Czech Republic

G.L. Pharma Gmbh

Convulex

Sodium Valproate 50 mg/Ml

Syrup

Oral Use

Czech Republic

G.L. Pharma Gmbh

Convulex Cr

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Czech Republic

G.L. Pharma Gmbh

Convulex Cr

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Czech Republic

Sanofi-Aventis Sro

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Czech Republic

Sanofi-Aventis Sro

Depakine

Sodium Valproate 57.64 mg/Ml

Syrup

Oral Use

Czech Republic

Sanofi-Aventis Sro

Depakine Chrono Secable

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Czech Republic

Sanofi-Aventis Sro

Depakine Chrono Secable

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Czech Republic

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Czech Republic

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Czech Republic

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Czech Republic

Desitin Arzneimittel Gmbh

Orfiril I.V.

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Czech Republic

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Czech Republic

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Czech Republic

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 1000 mg Tablet

Prolonged-Release Tablet

Oral Use

Czech Republic

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Czech Republic

Ratiopharm Gmbh

Valproat

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Czech Republic

Ratiopharm Gmbh

Valproat

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Czech Republic

Sandoz Gmbh

Valproat Chrono Sandoz

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Czech Republic

Sandoz Gmbh

Valproat Chrono Sandoz

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Denmark

Orion Corporation

Delepsine

Sodium Valproate 100 mg Tablet

Gastro-Resistant Tablet

Oral Use

Denmark

Orion Corporation

Delepsine

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Denmark

Orion Corporation

Delepsine

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Denmark

Orion Corporation

Delepsine

Sodium Valproate 200 mg/Ml

Oral Drops, Solution

Oral Use

Denmark

Orion Corporation

Delepsine

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Denmark

Orion Corporation

Delepsine

Sodium Valproate 300 mg Suppository

Suppository

Rectal Use

Denmark

Orion Corporation

Delepsine Retard

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Denmark

Sanofi-Aventis Denmark A/S

Deprakine

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Denmark

Sanofi-Aventis Denmark A/S

Deprakine

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Denmark

Sanofi-Aventis Denmark A/S

Deprakine Retard

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Denmark

Sanofi-Aventis Denmark A/S

Deprakine Retard

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Denmark

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Denmark

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Denmark

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Denmark

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Denmark

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Denmark

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Denmark

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 1000 mg Container

Prolonged-Release Granules

Oral Use

Denmark

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 500 mg Container

Prolonged-Release Granules

Oral Use

Denmark

Desitin Arzneimittel Gmbh

Orfiril Retard

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Estonia

G.L. Pharma Gmbh

Convulex

Sodium Valproate 500 mg/5 Ml

Concentrate For Solution For Injection/Infusion

Intravenous Use

Estonia

G.L. Pharma Gmbh

Convulex

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Estonia

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Estonia

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Estonia

G.L. Pharma Gmbh

Convulex

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Estonia

G.L. Pharma Gmbh

Convulex

Sodium Valproate 50 mg/Ml

Syrup

Oral Use

Estonia

G.L. Pharma Gmbh

Convulex Retard

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Estonia

G.L. Pharma Gmbh

Convulex Retard

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Estonia

Sanofi-Aventis Estonia Oü

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Estonia

Sanofi-Aventis Estonia Oü

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Estonia

Sanofi-Aventis Estonia Oü

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Estonia

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Estonia

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Estonia

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Estonia

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Estonia

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Estonia

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Estonia

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 500 mg Container

Prolonged-Release Granules

Oral Use

Estonia

Desitin Arzneimittel Gmbh

Orfiril Saft

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Estonia

Sandoz Pharmaceuticals D.D.

Valproate Sodium Sandoz

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Finland

Orion Oyj

Absenor

Sodium Valproate 100 mg Tablet

Gastro-Resistant Tablet

Oral Use

Finland

Orion Oyj

Absenor

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Finland

Orion Oyj

Absenor

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Finland

Orion Oyj

Absenor

Sodium Valproate 200 mg/Ml

Oral Drops, Solution

Oral Use

Finland

Orion Oyj

Absenor

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Finland

Orion Oyj

Absenor

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Finland

Orion Oyj

Absenor

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Finland

Sanofi Oy

Deprakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Finland

Sanofi Oy

Deprakine

Sodium Valproate 100 mg Tablet

Gastro-Resistant Tablet

Oral Use

Finland

Sanofi Oy

Deprakine

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Finland

Sanofi Oy

Deprakine

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Finland

Sanofi Oy

Deprakine

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Finland

Sanofi Oy

Deprakine

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Finland

Sanofi Oy

Deprakine

Sodium Valproate 200 mg/Ml

Oral Drops, Solution

Oral Use

Finland

Sanofi Oy

Deprakine

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Finland

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Finland

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Finland

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Finland

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 500 mg Container

Prolonged-Release Granules

Oral Use

Finland

Sandoz A/S

Valproat Sandoz

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Finland

Sandoz A/S

Valproat Sandoz

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

France

Sanofi-Aventis France

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

France

Sanofi-Aventis France

Depakine

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

France

Sanofi-Aventis France

Depakine

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

France

Sanofi-Aventis France

Depakine

Sodium Valproate 200 mg/Ml

Oral Solution

Oral Use

France

Sanofi-Aventis France

Depakine

Sodium Valproate 57.64 mg/Ml

Syrup

Oral Use

France

Sanofi-Aventis France

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

France

Sanofi-Aventis France

Depakote

Valproate Semisodium 250 mg Tablet

Gastro-Resistant Tablet

Oral Use

France

Sanofi-Aventis France

Depakote

Valproate Semisodium 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

France

Sanofi-Aventis France

Depamide

Valpromide 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

France

Sanofi-Aventis France

Micropakine L.P.

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Prolonged-Release Granules

Oral Use

France

Sanofi-Aventis France

Micropakine L.P.

Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet

Prolonged-Release Granules

Oral Use

France

Sanofi-Aventis France

Micropakine L.P.

Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet

Prolonged-Release Granules

Oral Use

France

Sanofi-Aventis France

Micropakine L.P.

Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet

Prolonged-Release Granules

Oral Use

France

Sanofi-Aventis France

Micropakine L.P.

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Prolonged-Release Granules

Oral Use

France

Laboratoire Aguettant

Valproate De Sodium Aguettant

Sodium Valproate 400 mg/4 Ml

Solution For Injection

Intravenous Use

France

Arrow Generiques

Valproate De Sodium Arrow

Sodium Valproate 200 mg/Ml

Oral Solution

Oral Use

France

Eg Labo Laboratoires Eurogenerics

Valproate De Sodium Eg L.P.

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

France

Arrow Generiques

Valproate De Sodium L.P Arrow

Sodium Valproate 500 mg Tablet

Film-Coated Tablet

Oral Use

France

Biogaran

Valproate De Sodium L.P. Biogaran

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

France

Sanofi-Aventis France

Valproate De Sodium Lp Zentiva

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

France

Mylan S.A.S

Valproate De Sodium Mylan

Sodium Valproate 500 mg Tablet

Modified-Release Tablet

Oral Use

France

Sandoz

Valproate De Sodium Sandoz

Sodium Valproate 500 mg Tablet

Modified-Release Tablet

Oral Use

France

Ratiopharm Gmbh

Valproate De Sodium Teva

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

France

Sanofi-Aventis France

Valproate De Sodium Zentiva

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

France

Sanofi-Aventis France

Valproate De Sodium Zentiva

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

France

Sanofi-Aventis France

Valproate De Sodium Zentiva

Sodium Valproate 200 mg/Ml

Oral Solution

Oral Use

Germany

G.L. Pharma Gmbh

Convulex

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Germany

G.L. Pharma Gmbh

Convulex

Sodium Valproate 300 mg Capsule

Prolonged-Release Tablet

Oral Use

Germany

G.L. Pharma Gmbh

Convulex

Sodium Valproate 500 mg Capsule

Prolonged-Release Tablet

Oral Use

Germany

G.L. Pharma Gmbh

Convulex®

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule

Oral Use

Germany

G.L. Pharma Gmbh

Convulex®

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule

Oral Use

Germany

G.L. Pharma Gmbh

Convulex®

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule

Oral Use

Germany

Sanofi-Aventis Deutschland Gmbh

Ergenyl

Sodium Valproate 400 mg Container

Powder And Solvent For Solution For Injection

Intravenous Use

Germany

Sanofi-Aventis Deutschland Gmbh

Ergenyl

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Germany

Sanofi-Aventis Deutschland Gmbh

Ergenyl

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Sanofi-Aventis Deutschland Gmbh

Ergenyl

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Sanofi-Aventis Deutschland Gmbh

Ergenyl

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Sanofi-Aventis Deutschland Gmbh

Ergenyl

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Germany

Sanofi-Aventis Deutschland Gmbh

Ergenyl Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Sanofi-Aventis Deutschland Gmbh

Ergenyl Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

(Art 57)

Espa-Valep Retard

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Aristo Pharma Gmbh (Art 57)

Espa-Valept

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Aristo Pharma Gmbh (Art 57)

Espa-Valept

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Aristo Pharma Gmbh (Art 57)

Espa-Valept Retard

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Riemser Pharma Gmbh

Leptilan

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Riemser Pharma Gmbh

Leptilan

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Riemser Pharma Gmbh

Leptilan

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Aristo Pharma Gmbh (Art 57)

Natriumvalproat Aristo

Sodium Valproate 300 mg G

Oral Drops, Solution

Oral Use

Germany

Hexal Ag

Natriumvalproat Hexal

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Germany

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Germany

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Germany

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Germany

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 1000 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Desitin Arzneimittel Gmbh

Orfiril Saft

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Germany

Iip — Institut Für Industrielle Pharmazie Forschungs- Und Entwicklungsgesellschaft Mbh

Valhel Pr

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Iip — Institut Für Industrielle Pharmazie Forschungs- Und Entwicklungsgesellschaft Mbh

Valhel Pr

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Aliud Pharma Gmbh

Valpro

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Betapharm Arzneimittel Gmbh

Valpro

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Aliud Pharma Gmbh

Valpro Al

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Betapharm Arzneimittel Gmbh

Valpro Beta

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Betapharm Arzneimittel Gmbh

Valpro Beta

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Betapharm Arzneimittel Gmbh

Valpro Beta

Sodium Valproate 300 mg/Ml

Oral Drops, Solution

Oral Use

Germany

Betapharm Arzneimittel Gmbh

Valpro Chrono

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Betapharm Arzneimittel Gmbh

Valpro Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Tad Pharma Gmbh

Valpro Tad

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Germany

Tad Pharma Gmbh

Valpro Tad

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Capsule

Oral Use

Germany

Tad Pharma Gmbh

Valpro Tad

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Capsule

Oral Use

Germany

Abz-Pharma Gmbh

Valproat

Sodium Valproate 150 mg Tablet

Film-Coated Tablet

Oral Use

Germany

Abz-Pharma Gmbh

Valproat

Valproic Acid 145 mg G, Sodium Valproate 333 mg G

Prolonged-Release Tablet

Oral Use

Germany

Abz-Pharma Gmbh

Valproat

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Ratiopharm Gmbh

Valproat

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Ratiopharm Gmbh

Valproat

Valproic Acid 87 mg G, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Stadapharm Gmbh

Valproat

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Stadapharm Gmbh

Valproat

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

1 A Pharma Gmbh

Valproat 1 A Pharma

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

1 A Pharma Gmbh

Valproat 1 A Pharma

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

1 A Pharma Gmbh

Valproat 1 A Pharma

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

1 A Pharma Gmbh

Valproat 1 A Pharma

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

1 A Pharma Gmbh

Valproat 1 A Pharma

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Aristo Pharma Gmbh (Art 57)

Valproat Aristo

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Aristo Pharma Gmbh (Art 57)

Valproat Aristo

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Abz-Pharma Gmbh

Valproat Chrono

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Abz-Pharma Gmbh

Valproat Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Desitin Arzneimittel Gmbh

Valproat Chrono

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Desitin Arzneimittel Gmbh

Valproat Chrono

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Glenmark Pharmaceuticals Europe Limited

Valproat Chrono

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Glenmark Pharmaceuticals Europe Limited

Valproat Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Winthrop Arzneimittel Gmbh

Valproat Chrono

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Winthrop Arzneimittel Gmbh

Valproat Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Hexal Ag

Valproat Chrono Hexal

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Hexal Ag

Valproat Chrono Hexal

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Germany

Hexal Ag

Valproat Hexal

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Hexal Ag

Valproat Hexal

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Hexal Ag

Valproat Hexal

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Germany

Neuraxpharm Arzneimittel Gmbh

Valproat Neuraxpharm

Sodium Valproate 150 mg Units

Gastro-Resistant Tablet

Oral Use

Germany

Neuraxpharm Arzneimittel Gmbh

Valproat Neuraxpharm

Sodium Valproate 300 mg Units

Gastro-Resistant Tablet

Oral Use

Germany

Neuraxpharm Arzneimittel Gmbh

Valproat Neuraxpharm

Sodium Valproate 600 mg Units

Gastro-Resistant Tablet

Oral Use

Germany

Neuraxpharm Arzneimittel Gmbh

Valproat Neuraxpharm

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Germany

Neuraxpharm Arzneimittel Gmbh

Valproat Neuraxpharm

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Germany

Neuraxpharm Arzneimittel Gmbh

Valproat Neuraxpharm

Sodium Valproate 300 mg Units

Prolonged-Release Tablet

Oral Use

Germany

Neuraxpharm Arzneimittel Gmbh

Valproat Neuraxpharm

Sodium Valproate 500 mg Units

Prolonged-Release Tablet

Oral Use

Germany

Orion Corporation

Valproat Orion

Sodium Valproate 300 mg Tablet

Tablet

Oral Use

Germany

Orion Corporation

Valproat Orion

Sodium Valproate 500 mg Tablet

Tablet

Oral Use

Germany

Abz-Pharma Gmbh

Valproat-Ct

Sodium Valproate 300 mg Tablet

Film-Coated Tablet

Oral Use

Germany

Abz-Pharma Gmbh

Valproat-Ct

Sodium Valproate 600 mg Tablet

Film-Coated Tablet

Oral Use

Germany

Ratiopharm Gmbh

Valproinsäure

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Germany

Ratiopharm Gmbh

Valproinsäure Ratiopharm

Sodium Valproate 150 mg Tablet

Film-Coated Tablet

Oral Use

Germany

Ratiopharm Gmbh

Valproinsäure Ratiopharm

Sodium Valproate 300 mg Tablet

Film-Coated Tablet

Oral Use

Germany

Ratiopharm Gmbh

Valproinsäure Ratiopharm

Sodium Valproate 600 mg Tablet

Film-Coated Tablet

Oral Use

Greece

Sanofi-Aventis Aebe

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Greece

Sanofi-Aventis Aebe

Depakine

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

Greece

Sanofi-Aventis Aebe

Depakine

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Greece

Sanofi-Aventis Aebe

Depakine

Sodium Valproate 200 mg/Ml

Oral Solution

Oral Use

Greece

Sanofi-Aventis Aebe

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Greece

Sanofi-Aventis Aebe

Depakine Chronosphere

Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet

Modified-Release Granules

Oral Use

Greece

Sanofi-Aventis Aebe

Depakine Chronosphere

Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet

Modified-Release Granules

Oral Use

Greece

Sanofi-Aventis Aebe

Depakine Chronosphere

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Modified-Release Granules

Oral Use

Greece

Demo Abee

Hexaquin

Sodium Valproate 400 mg Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

G.L. Pharma Gmbh

Convulex

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Hungary

G.L. Pharma Gmbh

Convulex

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Hungary

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Hungary

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Hungary

G.L. Pharma Gmbh

Convulex

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Hungary

G.L. Pharma Gmbh

Convulex

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Hungary

G.L. Pharma Gmbh

Convulex

Valproic Acid 43.38 mg/Ml

Syrup

Oral Use

Hungary

Sanofi-Aventis Zrt

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Hungary

Sanofi-Aventis Zrt

Depakine

Valproic Acid 50 mg/Ml

Syrup

Oral Use

Hungary

Sanofi-Aventis Zrt

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Hungary

Sanofi-Aventis Zrt

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Iceland

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Iceland

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Iceland

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Iceland

Desitin Arzneimittel Gmbh

Orfiril Retard

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim

Sodium Valproate 40 mg/Ml

Oral Solution

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim

Sodium Valproate 40 mg/Ml

Syrup

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim

Sodium Valproate 100 mg Tablet

Tablet

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim Chrono

Valproic Acid 58 mg Tablet, Sodium Valproate 133.2 mg Tablet

Prolonged-Release Tablet

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim Chronosphere

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Prolonged-Release Granules

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim Chronosphere

Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet

Prolonged-Release Granules

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim Chronosphere

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Prolonged-Release Granules

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim Enteric

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

Ireland

Sanofi-Aventis Ireland Ltd T/A SANOFI

Epilim Enteric

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Eg S.P.A.

Acido Valproico E Sodio Valproato Eg

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Italy

Eg S.P.A.

Acido Valproico E Sodio Valproato Eg

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Italy

Ratiopharm Gmbh

Acido Valproico E Sodio Valproato Ratiopharm

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Italy

Ratiopharm Gmbh

Acido Valproico E Sodio Valproato Ratiopharm

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Italy

Ratiopharm Gmbh

Acido Valproico E Sodio Valproato Ratiopharm Ratiopharm

Valproic Acid 145 mg G, Sodium Valproate 333 mg G

Prolonged-Release Tablet

Oral Use

Italy

Sandoz S.P.A.

Acido Valproico Sandoz

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Italy

Sandoz S.P.A.

Acido Valproico Sandoz

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Italy

Sanofi Spa

Depakin

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Italy

Sanofi Spa

Depakin

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Sanofi Spa

Depakin

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Sanofi Spa

Depakin

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Modified-Release Granules

Oral Use

Italy

Sanofi Spa

Depakin

Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet

Modified-Release Granules

Oral Use

Italy

Sanofi Spa

Depakin

Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet

Modified-Release Granules

Oral Use

Italy

Sanofi Spa

Depakin

Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet

Modified-Release Granules

Oral Use

Italy

Sanofi Spa

Depakin

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Modified-Release Granules

Oral Use

Italy

Sanofi Spa

Depakin

Sodium Valproate 200 mg/Ml

Oral Solution

Oral Use

Italy

Sanofi Spa

Depakin Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Italy

Sanofi Spa

Depakin Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Italy

Alfasigma S.p.A.

Depamag

Valproate Magnesium 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Alfasigma S.p.A.

Depamag

Valproate Magnesium 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Alfasigma S.p.A.

Depamag

Valproate Magnesium 10000 mg/100 Ml

Oral Solution

Oral Use

Italy

Sanofi Spa

Depamide

Valpromide 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Zentiva Italia Srl

Sodio Valproato

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Zentiva Italia Srl

Sodio Valproato

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Zentiva Italia Srl

Sodio Valproato

Sodium Valproate 200 mg/Ml

Oral Solution

Oral Use

Italy

Zentiva Italia Srl

Sodio Valproato

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Italy

Zentiva Italia Srl

Sodio Valproato

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Latvia

Orion Corporation

Absenor

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Latvia

G.L. Pharma Gmbh

Convulex

Sodium Valproate 500 mg/5 Ml

Concentrate For Solution For Injection/Infusion

Intravenous Use

Latvia

G.L. Pharma Gmbh

Convulex

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Latvia

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Latvia

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Latvia

G.L. Pharma Gmbh

Convulex

Sodium Valproate 50 mg/Ml

Syrup

Oral Use

Latvia

G.L. Pharma Gmbh

Convulex®

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Latvia

G.L. Pharma Gmbh

Convulex® Retard

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Latvia

G.L. Pharma Gmbh

Convulex® Retard

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Latvia

Sanofi-Aventis Latvia Sia

Depakine

Sodium Valproate 57.64 mg/Ml

Syrup

Oral Use

Latvia

Sanofi-Aventis Latvia Sia

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Latvia

Sanofi-Aventis Latvia Sia

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Lithuania

Orion Corporation

Absenor

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Lithuania

G.L. Pharma Gmbh

Convulex

Sodium Valproate 100 mg/Ml

Solution For Injection/Infusion

Intravenous Use

Lithuania

G.L. Pharma Gmbh

Convulex

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Lithuania

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Lithuania

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Lithuania

G.L. Pharma Gmbh

Convulex

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Lithuania

G.L. Pharma Gmbh

Convulex

Sodium Valproate 50 mg/Ml

Syrup

Oral Use

Lithuania

G.L. Pharma Gmbh

Convulex Retard

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Lithuania

G.L. Pharma Gmbh

Convulex Retard

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Lithuania

Uab ‘Sanofi-Aventis Lietuva’

Depakine

Sodium Valproate 57.64 mg/Ml

Syrup

Oral Use

Lithuania

Uab ‘Sanofi-Aventis Lietuva’

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Lithuania

Uab ‘Sanofi-Aventis Lietuva’

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Lithuania

Uab ‘Sanofi-Aventis Lietuva’

Depakine Chronosphere

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Modified-Release Granules

Oral Use

Lithuania

Uab ‘Sanofi-Aventis Lietuva’

Depakine Chronosphere

Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet

Modified-Release Granules

Oral Use

Lithuania

Uab ‘Sanofi-Aventis Lietuva’

Depakine Chronosphere

Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet

Modified-Release Granules

Oral Use

Lithuania

Uab ‘Sanofi-Aventis Lietuva’

Depakine Chronosphere

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Modified-Release Granules

Oral Use

Lithuania

Sandoz Pharmaceuticals D.D.

Valproate Sodium Sandoz

Sodium Valproate 500 mg Tablet

Modified-Release Tablet

Oral Use

Luxembourg

Sanofi Belgium

Depakine

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Luxembourg

Sanofi Belgium

Depakine

Sodium Valproate 60 mg/Ml

Syrup

Oral Use

Luxembourg

Sanofi Belgium

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Luxembourg

Sanofi Belgium

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Luxembourg

Sanofi Belgium

Depakine Enteric

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Luxembourg

Sanofi Belgium

Depakine Enteric

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Luxembourg

Sanofi Belgium

Depakine Enteric

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Luxembourg

Sanofi Belgium

Depakine I.V.

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Luxembourg

Ratiopharm Gmbh

Valproat

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Luxembourg

Ratiopharm Gmbh

Valproat Ratiopharm

Valproic Acid 145 mg G, Sodium Valproate 333 mg G

Prolonged-Release Tablet

Oral Use

Luxembourg

Eurogenerics N.V./S.A.

Valproate Retard Eg

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Luxembourg

Eurogenerics N.V./S.A.

Valproate Retard Eg

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Luxembourg

Mylan Bvba/Sprl

Valproate Retard Mylan

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Luxembourg

Mylan Bvba/Sprl

Valproate Retard Mylan

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Malta

Sanofi Malta Ltd

Epilim

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Malta

Sanofi Malta Ltd

Epilim

Sodium Valproate 200 mg/5 Ml

Oral Solution

Oral Use

Malta

Sanofi Malta Ltd

Epilim Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Malta

Sanofi Malta Ltd

Epilim Chrono

Valproic Acid 58 mg Tablet, Sodium Valproate 133.2 mg Tablet

Modified-Release Tablet

Oral Use

Malta

Sanofi Malta Ltd

Epilim Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Malta

Wockhardt Uk Ltd

Sodium Valproate Wockhardt Uk

Sodium Valproate 100 mg/Ml

Solution For Injection/Infusion

Intravenous Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine

Sodium Valproate 40 mg/Ml

Syrup

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Chronosphere

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Modified-Release Granules

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Chronosphere

Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet

Modified-Release Granules

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Chronosphere

Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet

Modified-Release Granules

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Chronosphere

Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet

Modified-Release Granules

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Chronosphere

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Modified-Release Granules

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Enteric

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Enteric

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Netherlands

Sanofi-Aventis Netherlands B.V.

Depakine Enteric

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Netherlands

Apotex Europe B.V.

Natriumvalproaat Apotex

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Netherlands

Apotex Europe Bv

Natriumvalproaat Apotex

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Netherlands

Apotex Europe Bv

Natriumvalproaat Apotex

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Netherlands

Apotex Europe Bv

Natriumvalproaat Apotex

Sodium Valproate 300 mg/5 Ml

Oral Solution

Oral Use

Netherlands

Teva Nederland B.V.

Natriumvalproaat Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Netherlands

Centrafarm B.V.

Natriumvalproaat Chrono Cf

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Netherlands

Centrafarm B.V.

Natriumvalproaat Chrono Cf

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Netherlands

Sandoz B.V.

Natriumvalproaat Chrono Sandoz

Sodium Valproate 300 mg Tablet

Modified-Release Tablet

Oral Use

Netherlands

Sandoz B.V.

Natriumvalproaat Chrono Sandoz

Sodium Valproate 500 mg Tablet

Modified-Release Tablet

Oral Use

Netherlands

Sandoz B.V.

Natriumvalproaat Sandoz

Sodium Valproate 300 mg Tablet

Modified-Release Tablet

Oral Use

Netherlands

Sandoz B.V.

Natriumvalproaat Sandoz

Sodium Valproate 500 mg Tablet

Modified-Release Tablet

Oral Use

Netherlands

Teva Nederland B.V.

Natriumvalproaat Teva

Valproic Acid 145 mg G, Sodium Valproate 333 mg G

Prolonged-Release Tablet

Oral Use

Netherlands

Pharmachemie B.V

Orfiril

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Netherlands

Pharmachemie B.V

Orfiril Cr

Sodium Valproate 300 mg Capsule

Modified-Release Capsule, Hard

Oral Use

Netherlands

Pharmachemie B.V

Orfiril Cr

Sodium Valproate 1000 mg Sachet

Modified-Release Granules

Oral Use

Netherlands

Pharmachemie B.V

Orfiril Cr

Sodium Valproate 500 mg Sachet

Modified-Release Granules

Oral Use

Norway

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Norway

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Norway

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Norway

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Norway

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Norway

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Norway

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule

Oral Use

Norway

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 300 mg

Prolonged-Release Capsule

Oral Use

Norway

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 1000 mg Container

Prolonged-Release Granules

Oral Use

Norway

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 500 mg Container

Prolonged-Release Granules

Oral Use

Poland

Orion Corporation

Absenor

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Poland

Orion Corporation

Absenor

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Poland

G.L. Pharma Gmbh

Convival Chrono

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Poland

G.L. Pharma Gmbh

Convulex

Valproic Acid 150 mg Capsule

Capsule, Soft

Oral Use

Poland

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Capsule, Soft

Oral Use

Poland

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Capsule, Soft

Oral Use

Poland

G.L. Pharma Gmbh

Convulex

Sodium Valproate 50 mg/Ml

Syrup

Oral Use

Poland

Sanofi-Aventis France

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Poland

Sanofi-Aventis France

Depakine

Sodium Valproate 40 mg/Ml

Syrup

Oral Use

Poland

Sanofi-Aventis Sp Z.O.O.

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Poland

Sanofi-Aventis Sp Z.O.O.

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Poland

Sanofi-Aventis Sp Z.O.O.

Depakine Chronosphere

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Modified-Release Granules

Oral Use

Poland

Sanofi-Aventis Sp Z.O.O.

Depakine Chronosphere

Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet

Modified-Release Granules

Oral Use

Poland

Sanofi-Aventis Sp Z.O.O.

Depakine Chronosphere

Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet

Modified-Release Granules

Oral Use

Poland

Sanofi-Aventis Sp Z.O.O.

Depakine Chronosphere

Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet

Modified-Release Granules

Oral Use

Poland

Sanofi-Aventis Sp Z.O.O.

Depakine Chronosphere

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Modified-Release Granules

Oral Use

Poland

Pharmaswiss česká Republika S.R.O.

Dipromal

Valproate Magnesium 200 mg Tablet

Film-Coated Tablet

Oral Use

Poland

Sandoz Gmbh

Valprolek

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Poland

Sandoz Gmbh

Valprolek

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Generis Farmacêutica, S.A.

ácido Valpróico Generis

Valproic Acid 400 mg/4 Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Generis Farmacêutica, S.A.

ácido Valpróico Generis

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Generis Farmacêutica, S.A.

ácido Valpróico Generis

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Sandoz Farmacêutica Lda.

ácido Valpróico Sandoz

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Sandoz Farmacêutica Lda.

ácido Valpróico Sandoz

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine

Sodium Valproate 200 mg/Ml

Oral Solution

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine

Sodium Valproate 40 mg/Ml

Syrup

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chrono 300

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chrono 300

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chrono 500

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chronosphere

Valproic Acid 14.51 mg Sachet, Sodium Valproate 33.33 mg Sachet

Modified-Release Granules

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chronosphere

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Modified-Release Granules

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chronosphere

Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet

Modified-Release Granules

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chronosphere

Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet

Modified-Release Granules

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chronosphere

Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet

Modified-Release Granules

Oral Use

Portugal

Sanofi — Produtos Farmaceuticos Lda

Depakine Chronosphere

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Modified-Release Granules

Oral Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil

Sodium Valproate 200 mg Tablet

Coated Tablet

Oral Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil

Sodium Valproate 200 mg/Ml

Oral Solution

Oral Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule

Oral Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule

Oral Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil

Sodium Valproate 1000 mg Sachet

Prolonged-Release Granules

Oral Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil

Sodium Valproate 500 mg Sachet

Prolonged-Release Granules

Oral Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil-R

Valproate Semisodium 269.1 mg Tablet

Gastro-Resistant Tablet

Oral Use

Portugal

Tecnifar, Indústria Técnica Farmacêutica, Sa

Diplexil-R

Valproate Semisodium 538.2 mg Tablet

Gastro-Resistant Tablet

Oral Use

Portugal

Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Portugal

Ratiopharm-Comercio E Industria De Produtos Farmaceuticos Lda

Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Romania

Lannacher Heilmittel Ges.M.B.H.,

Convulex

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Romania

Lannacher Heilmittel Ges.M.B.H.,

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Romania

Lannacher Heilmittel Ges.M.B.H.,

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Romania

Sanofi-Aventis France

Depakine

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

Romania

Sanofi-Aventis France

Depakine

Sodium Valproate 57.64 mg/Ml

Syrup

Oral Use

Romania

Sanofi-Aventis France

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

Romania

Sanofi-Aventis France

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

Romania

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 300 mg/5 Ml

Oral Solution

Oral Use

Romania

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Romania

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Romania

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 1000 mg Sachet

Prolonged-Release Granules In Sachet

Oral Use

Romania

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 500 mg Sachet

Prolonged-Release Granules In Sachet

Oral Use

Romania

Arena Group S.A

Valepil

Sodium Valproate 200 mg/5 Ml

Syrup

Oral Use

Slovakia

G.L. Pharma Gmbh

Convulex

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Slovakia

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Slovakia

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

Slovakia

G.L. Pharma Gmbh

Convulex

Sodium Valproate 300 mg/Ml

Oral Solution

Oral Use

Slovakia

G.L. Pharma Gmbh

Convulex

Sodium Valproate 50 mg/Ml

Syrup

Oral Use

Slovakia

G.L. Pharma Gmbh

Convulex Cr

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Slovakia

Sanofi-Aventis Slovakia Sro

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Slovakia

Sanofi-Aventis Slovakia Sro

Depakine

Sodium Valproate 57.64 mg/Ml

Syrup

Oral Use

Slovakia

Sanofi-Aventis Slovakia Sro

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Slovakia

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

Slovakia

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Slovakia

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Slovakia

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 600 mg Tablet

Gastro-Resistant Tablet

Oral Use

Slovakia

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule

Oral Use

Slovakia

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule

Oral Use

Slovakia

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 1000 mg Tablet

Prolonged-Release Tablet

Oral Use

Slovakia

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Slovakia

Ratiopharm Gmbh

Valpro

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Slovakia

Sandoz Pharmaceuticals D.D.

Valproát Chrono Sandoz

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Slovakia

Sandoz Pharmaceuticals D.D.

Valproát Chrono Sandoz

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Slovenia

Sanofi-Aventis D.O.O.

Depakine Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Slovenia

Sanofi-Aventis D.O.O.

Depakine Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Spain

G.E.S. Genéricos Españoles Laboratorio, S.A.

ácido Valproico G.E.S

Sodium Valproate 400 mg Vial

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Sanofi-Aventis, S.A.

Depakine

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Spain

Sanofi-Aventis, S.A.

Depakine

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

Spain

Sanofi-Aventis, S.A.

Depakine

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Spain

Sanofi-Aventis, S.A.

Depakine

Sodium Valproate 200 mg/Ml

Oral Solution

Oral Use

Spain

Sanofi-Aventis, S.A.

Depakine Crono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Spain

Sanofi-Aventis, S.A.

Depakine Crono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Spain

Sanofi-Aventis, S.A.

Depakine Crono

Valproic Acid 145 mg Tablet, Sodium Valproate 333 mg Tablet

Prolonged-Release Tablet

Oral Use

Spain

Sanofi-Aventis, S.A.

Depakine Crono

Valproic Acid 87 mg Tablet, Sodium Valproate 200 mg Tablet

Prolonged-Release Tablet

Oral Use

Sweden

Orion Corporation

Absenor

Sodium Valproate 100 mg Tablet

Gastro-Resistant Tablet

Oral Use

Sweden

Orion Corporation

Absenor

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Sweden

Orion Corporation

Absenor

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Sweden

Orion Corporation

Absenor

Sodium Valproate 200 mg/Ml

Oral Drops, Solution

Oral Use

Sweden

Orion Corporation

Absenor

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Sweden

Orion Corporation

Absenor Depot

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

Sweden

Orion Corporation

Absenor Depot

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

Sweden

Sanofi Ab

Ergenyl

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

Sweden

Sanofi Ab

Ergenyl

Sodium Valproate 100 mg Tablet

Gastro-Resistant Tablet

Oral Use

Sweden

Sanofi Ab

Ergenyl

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Sweden

Sanofi Ab

Ergenyl

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

Sweden

Sanofi Ab

Ergenyl

Sodium Valproate 200 mg/Ml

Oral Drops, Solution

Oral Use

Sweden

Sanofi Ab

Ergenyl

Sodium Valproate 60 mg/Ml

Oral Solution

Oral Use

Sweden

Sanofi Ab

Ergenyl Retard

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Modified-Release Granules

Oral Use

Sweden

Sanofi Ab

Ergenyl Retard

Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet

Modified-Release Granules

Oral Use

Sweden

Sanofi Ab

Ergenyl Retard

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Modified-Release Granules

Oral Use

Sweden

Sanofi Ab

Ergenyl Retard

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Modified-Release Tablet

Oral Use

Sweden

Sanofi Ab

Ergenyl Retard

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Modified-Release Tablet

Oral Use

Sweden

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 150 mg Tablet

Gastro-Resistant Tablet

Oral Use

Sweden

Desitin Arzneimittel Gmbh

Orfiril

Sodium Valproate 300 mg Tablet

Gastro-Resistant Tablet

Oral Use

Sweden

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Sweden

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

Sweden

Desitin Arzneimittel Gmbh

Orfiril Long

Sodium Valproate 500 mg Container

Prolonged-Release Granules

Oral Use

United Kingdom

G.L. Pharma Gmbh

Convulex

Valproic Acid 150 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

United Kingdom

G.L. Pharma Gmbh

Convulex

Valproic Acid 300 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

United Kingdom

G.L. Pharma Gmbh

Convulex

Valproic Acid 500 mg Capsule

Gastro-Resistant Capsule, Soft

Oral Use

United Kingdom

Aventis Pharma Ltd

Depakote

Valproate Semisodium 269.1 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Aventis Pharma Ltd

Depakote

Valproate Semisodium 538.2 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim

Sodium Valproate 400 mg/Ml

Powder And Solvent For Solution For Injection

Intravenous Use

United Kingdom

Aventis Pharma Ltd

Epilim

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim

Sodium Valproate 40 mg/Ml

Oral Solution

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim

Sodium Valproate 40 mg/Ml

Syrup

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim

Sodium Valproate 100 mg Tablet

Tablet

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim Chrono

Valproic Acid 145.14 mg Tablet, Sodium Valproate 333.3 mg Tablet

Prolonged-Release Tablet

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim Chrono

Valproic Acid 58 mg Tablet, Sodium Valproate 133.2 mg Tablet

Prolonged-Release Tablet

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim Chrono

Valproic Acid 87 mg Tablet, Sodium Valproate 199.8 mg Tablet

Prolonged-Release Tablet

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim Chronosphere

Valproic Acid 14.51 mg Sachet, Sodium Valproate 33.33 mg Sachet

Modified-Release Granules

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim Chronosphere

Valproic Acid 145.14 mg Sachet, Sodium Valproate 333.3 mg Sachet

Modified-Release Granules

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim Chronosphere

Valproic Acid 217.75 mg Sachet, Sodium Valproate 500.06 mg Sachet

Modified-Release Granules

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim Chronosphere

Valproic Acid 29.03 mg Sachet, Sodium Valproate 66.66 mg Sachet

Modified-Release Granules

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim Chronosphere

Valproic Acid 290.27 mg Sachet, Sodium Valproate 666.6 mg Sachet

Modified-Release Granules

Oral Use

United Kingdom

Aventis Pharma Ltd

Epilim Chronosphere

Valproic Acid 72.61 mg Sachet, Sodium Valproate 166.76 mg Sachet

Modified-Release Granules

Oral Use

United Kingdom

Desitin Arzneimittel Gmbh

Episenta

Sodium Valproate 100 mg/Ml

Solution For Injection

Intravenous Use

United Kingdom

Desitin Arzneimittel Gmbh

Episenta

Sodium Valproate 150 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

United Kingdom

Desitin Arzneimittel Gmbh

Episenta

Sodium Valproate 300 mg Capsule

Prolonged-Release Capsule, Hard

Oral Use

United Kingdom

Desitin Arzneimittel Gmbh

Episenta

Sodium Valproate 1000 mg Sachet

Prolonged-Release Granules

Oral Use

United Kingdom

Desitin Arzneimittel Gmbh

Episenta

Sodium Valproate 500 mg Sachet

Prolonged-Release Granules

Oral Use

United Kingdom

G.L. Pharma Gmbh

Epival Cr

Sodium Valproate 300 mg Tablet

Prolonged-Release Tablet

Oral Use

United Kingdom

G.L. Pharma Gmbh

Epival Cr

Sodium Valproate 500 mg Tablet

Prolonged-Release Tablet

Oral Use

United Kingdom

Norton Healthcare Ltd T/A Ivax Pharmaceuticals Uk

Kentlim Opd

Sodium Valproate Bp 200 mg

Oral Solution

Oral Use

United Kingdom

Winthrop Pharmaceuticals Uk Ltd

Sodium Valproate

Sodium Valproate 40 mg/Ml

Oral Solution

Oral Use

United Kingdom

Norton Healthcare Ltd T/A Ivax Pharmaceuticals Uk

Sodium Valproate Ivax

Sodium Valproate 200 mg/5 Ml

Oral Solution

Oral Use

United Kingdom

Noridem Enterprises Ltd

Sodium Valproate Noridem Enterprises

Sodium Valproate 400 mg Vial

Powder And Solvent For Solution For Injection/Infusion

Intravenous Use

United Kingdom

Teva Uk Limited

Sodium Valproate Teva

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Teva Uk Limited

Sodium Valproate Teva

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Winthrop Pharmaceuticals Uk Ltd

Sodium Valproate Winthrop

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Winthrop Pharmaceuticals Uk Ltd

Sodium Valproate Winthrop

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Wockhardt Uk Ltd

Sodium Valproate Wockhardt

Sodium Valproate 100 mg/Ml

Solution For Injection/Infusion

Intravenous Use

United Kingdom

Wockhardt Uk Ltd

Sodium Valproate Wockhardt

Sodium Valproate 200 mg

Gastro-Resistant Tablet

Oral Use

United Kingdom

Wockhardt Uk Ltd

Sodium Valproate Wockhardt

Sodium Valproate 200 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Wockhardt Uk Ltd

Sodium Valproate Wockhardt

Sodium Valproate 500 mg Tablet

Gastro-Resistant Tablet

Oral Use

United Kingdom

Wockhardt Uk Ltd

Sodium Valproate Wockhardt

Sodium Valproate 200 mg/5 Ml

Oral Solution

Oral Use

United Kingdom

Wockhardt Uk Ltd

Sodium Valproate Wockhardt Uk

Sodium Valproate 500 mg

Gastro-Resistant Tablet

Oral Use

United Kingdom

Norton Healthcare Ltd T/A Ivax Pharmaceuticals Uk

Valpal

Sodium Valproate 200 mg/5 Ml

Oral Solution

Oral Use

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