# Official Journal C 394/29 S

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 394 |
| | |
| English edition | Information and Notices | Volume 6429 September 2021 |

ISSN 1977-091X

Official Journal

of the European Union

C 394

English edition

Information and Notices

Volume 6429 September 2021

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 394/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2021 to 31 August 2021(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2021/C 394/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2021 to 31 August 2021(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 9 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 394/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2021 to 31 August 2021(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

2021/C 394/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2021 to 31 August 2021(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)

9

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.9.2021 | EN | Official Journal of the European Union | C 394/1 |
| --- | --- | --- | --- |

29.9.2021

EN

Official Journal of the European Union

C 394/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2021 to 31 August 2021

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

(2021/C 394/01)

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.8.2021 | Abecma | idecabtagene vicleucel | Celgene Europe B.V. |
| Winthontlaan 6 N, 3526 KV Utrecht, Nederland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

18.8.2021

Abecma

idecabtagene vicleucel

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/21/1539

Dispersion for infusion

L01

19.8.2021

18.8.2021

Byooviz

ranibizumab

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/21/1572

Solution for injection

S01LA04

1.9.2021

18.8.2021

Evrenzo

roxadustat

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, 2333 BE Leiden, Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/21/1574

Film-coated tablet

B03XA05

19.8.2021

18.8.2021

Fingolimod Mylan

fingolimod

| Mylan Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/21/1573

Capsule, hard

L04AA27

1.9.2021

20.8.2021

Abiraterone Mylan

abiraterone acetate

| Mylan Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/21/1571

Film-coated tablet

L02BX03

1.9.2021

20.8.2021

Bimzelx

bimekizumab

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

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

EU/1/21/1575

Solution for injection

L04AC21

23.8.2021

26.8.2021

Minjuvi

tafasitamab

| Incyte Biosciences Distribution B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1570

Powder for concentrate for solution for infusion

L01FX12

1.9.2021

26.8.2021

Voxzogo

vosoritide

| BioMarin International Limited |
| --- |
| Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland |

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/21/1577

Powder and solvent for solution for injection

M05BX07

1.9.2021

—   Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.8.2021 | CANCIDAS | Merck Sharp & Dohme B.V. |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

2.8.2021

CANCIDAS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/01/196

31.8.2021

2.8.2021

Emadine

| Immedica Pharma AB |
| --- |
| SE-113 29 Stockholm, Sverige |

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/98/095

5.8.2021

2.8.2021

Hepcludex

| MYR GmbH |
| --- |
| Hessenring 89, 61348 Bad Homburg, Deutschland |

MYR GmbH

Hessenring 89, 61348 Bad Homburg, Deutschland

EU/1/20/1446

9.8.2021

2.8.2021

Tolura

| KRKA d d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/10/632

16.8.2021

5.8.2021

Forxiga

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

6.8.2021

12.8.2021

AMGEVITA

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1164

13.8.2021

12.8.2021

Azacitidine Mylan

| Mylan Ireland Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/20/1426

13.8.2021

12.8.2021

Combivir

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/98/058

13.8.2021

12.8.2021

Cometriq

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

13.8.2021

12.8.2021

Imatinib Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

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

EU/1/13/845

13.8.2021

12.8.2021

Pegasys

| zr pharma& GmbH |
| --- |
| Hietzinger Hauptstrasse 37, 1130 Wien, Österreich |

zr pharma& GmbH

Hietzinger Hauptstrasse 37, 1130 Wien, Österreich

EU/1/02/221

30.8.2021

12.8.2021

Taltz

| Eli Lilly and Company (Ireland) Limited |
| --- |
| Dunderrow, Kinsale, Co. Cork, Ireland |

Eli Lilly and Company (Ireland) Limited

Dunderrow, Kinsale, Co. Cork, Ireland

EU/1/15/1085

30.8.2021

18.8.2021

Fiasp

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

19.8.2021

18.8.2021

Givlaari

| Alnylam Netherlands B.V. |
| --- |
| Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland |

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/20/1428

19.8.2021

18.8.2021

Noxafil

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

1.9.2021

18.8.2021

Ofev

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

19.8.2021

18.8.2021

Ogivri

| Viatris Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1341

31.8.2021

18.8.2021

Rybelsus

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1430

19.8.2021

18.8.2021

Rydapt

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/17/1218

19.8.2021

18.8.2021

Suboxone

| Indivior Europe Limited |
| --- |
| 27 Windsor Place, Dublin 2, D02 DK44, Ireland |

Indivior Europe Limited

27 Windsor Place, Dublin 2, D02 DK44, Ireland

EU/1/06/359

19.8.2021

18.8.2021

TAVLESSE

| Instituto Grifols, S.A. |
| --- |
| Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa |

Instituto Grifols, S.A.

Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa

EU/1/19/1405

31.8.2021

18.8.2021

Truxima

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

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

EU/1/16/1167

19.8.2021

18.8.2021

VITRAKVI

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/19/1385

20.8.2021

18.8.2021

Voriconazole Hikma

| Hikma Farmacêutica (Portugal), S.A. |
| --- |
| Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal |

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

23.8.2021

18.8.2021

Xeljanz

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/17/1178

19.8.2021

18.8.2021

Zostavax

| MSD VACCINS |
| --- |
| 162 avenue Jean Jaurès, 69007 Lyon, France |

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/341

19.8.2021

20.8.2021

AFSTYLA

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/16/1158

24.8.2021

20.8.2021

Apidra

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/04/285

23.8.2021

20.8.2021

Blitzima

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1205

23.8.2021

20.8.2021

Caelyx pegylated liposomal

| Baxter Holding B.V. |
| --- |
| Kobaltweg 49, 3542 CE Utrecht, Nederland |

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/96/011

23.8.2021

20.8.2021

Copiktra

| Secura Bio Limited |
| --- |
| 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland |

Secura Bio Limited

32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland

EU/1/21/1542

23.8.2021

20.8.2021

Dovato

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/19/1370

23.8.2021

20.8.2021

Evra

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21, 1103 Budapest, Magyarország |

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/02/223

23.8.2021

20.8.2021

Imatinib Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/825

23.8.2021

20.8.2021

IMBRUVICA

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

23.8.2021

20.8.2021

Insuman

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

23.8.2021

20.8.2021

Kivexa

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/04/298

23.8.2021

20.8.2021

Rinvoq

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

23.8.2021

20.8.2021

Rixathon

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1185

23.8.2021

20.8.2021

Ruxience

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/20/1431

23.8.2021

20.8.2021

Tecentriq

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

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

EU/1/17/1220

24.8.2021

20.8.2021

Trizivir

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/00/156

23.8.2021

20.8.2021

Veklury

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

26.8.2021

26.8.2021

Adakveo

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/20/1476

27.8.2021

26.8.2021

Combivir

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/98/058

27.8.2021

26.8.2021

Efficib

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/457

27.8.2021

26.8.2021

Inhixa

| Techdow Pharma Netherlands B.V. |
| --- |
| Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland |

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland

EU/1/16/1132

27.8.2021

26.8.2021

Mabthera

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

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

EU/1/98/067

27.8.2021

26.8.2021

Mekinist

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/14/931

27.8.2021

26.8.2021

Riximyo

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1184

30.8.2021

26.8.2021

SonoVue

| Bracco International B.V. |
| --- |
| Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland |

Bracco International B.V.

Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland

EU/1/01/177

30.8.2021

26.8.2021

Stivarga

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

2.9.2021

26.8.2021

Tafinlar

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/13/865

27.8.2021

26.8.2021

Tenofovir disoproxil Mylan

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1129

27.8.2021

26.8.2021

Xarelto

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

27.8.2021

27.8.2021

Granpidam

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

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

EU/1/16/1137

30.8.2021

27.8.2021

Ristaben

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/621

7.9.2021

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.8.2021 | FATROVAX RHD | Rabbit haemorrhagic disease vaccine (inactivated, recombinant) | FATRO S.p.A. |
| Via Emilia 285, 40064 Ozzano dell’Emilia (BO), ITALIA |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

16.8.2021

FATROVAX RHD

Rabbit haemorrhagic disease vaccine (inactivated, recombinant)

FATRO S.p.A.

Via Emilia 285, 40064 Ozzano dell’Emilia (BO), ITALIA

EU/2/21/275

Suspension for injection

QI08AA01

17.8.2021

16.8.2021

Strangvac

Streptococcus equi vaccine (recombinant proteins)

| Intervacc AB |
| --- |
| Vastertorpsvagen 135, 129 44 Hagersten, Sverige |

Intervacc AB

Vastertorpsvagen 135, 129 44 Hagersten, Sverige

EU/2/21/274

Suspension for injection

Pending

17.8.2021

16.8.2021

Tessie

tasipimidine

| Orion Corporation |
| --- |
| Orionintie 1, 02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/21/276

Oral solution

QN05CM96

17.8.2021

—   Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.8.2021 | ERAVAC | Laboratorios Hipra, S.A. |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

16.8.2021

ERAVAC

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/16/199

25.8.2021

18.8.2021

NASYM

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/19/241

1.9.2021

18.8.2021

Sedadex

| Le Vet Beheer B.V. |
| --- |
| Wilgenweg 7, 3421 TV Oudewater, Nederland |

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/16/198

1.9.2021

30.8.2021

ECOPORC SHIGA

| Ceva Santé Animale |
| --- |
| 10 avenue de La Ballastière, 33500 Libourne, France |

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/13/149

31.8.2021

—   Withdrawal of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.8.2021 | Porcilis Pesti | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

16.8.2021

Porcilis Pesti

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/99/016

19.8.2021

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

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

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

---

| 29.9.2021 | EN | Official Journal of the European Union | C 394/9 |
| --- | --- | --- | --- |

29.9.2021

EN

Official Journal of the European Union

C 394/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2021 to 31 August 2021

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

(2021/C 394/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 30.8.2021 | Ronaxan and its associated names | doxycycline | See Annex I | See Annex I | 31.8.2021 |
| 18.8.2021 | Injectable veterinary medicinal products containing vitamin A for use in food producing species | Vitamin A (retinol and its esters) | See Annex II | See Annex II | 19.8.2021 |

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

30.8.2021

Ronaxan and its associated names

doxycycline

See Annex I

See Annex I

31.8.2021

18.8.2021

Injectable veterinary medicinal products containing vitamin A for use in food producing species

Vitamin A (retinol and its esters)

See Annex II

See Annex II

19.8.2021

—   Suspension 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 |
| --- | --- | --- | --- | --- | --- |
| 18.8.2021 | Injectable veterinary medicinal products containing vitamin A for use in food producing species | Vitamin A (retinol and its esters) | See Annex II | See Annex II | 19.8.2021 |

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

18.8.2021

Injectable veterinary medicinal products containing vitamin A for use in food producing species

Vitamin A (retinol and its esters)

See Annex II

See Annex II

19.8.2021

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States

| Member State EU/EEA | Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Belgium | Boehringer Ingelheim Animal Health Belgium SA |
| Avenue Arnaud Fraiteurlaan, 15-23 |
| 1050 Brussels |
| Belgium |

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Belgium

Boehringer Ingelheim Animal Health Belgium SA

Avenue Arnaud Fraiteurlaan, 15-23

1050 Brussels

Belgium

Ronaxan 20 mg

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Belgium

| Boehringer Ingelheim Animal Health Belgium SA |
| --- |
| Avenue Arnaud Fraiteurlaan, 15-23 |
| 1050 Brussels |
| Belgium |

Boehringer Ingelheim Animal Health Belgium SA

Avenue Arnaud Fraiteurlaan, 15-23

1050 Brussels

Belgium

Ronaxan 100 mg

Doxycycline

100 mg

Tablets

Dogs

Oral use

Croatia

| Boehringer Ingelheim Animal Health France SCS, |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS,

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 100 mg, tablete za pse

Doxycycline

100 mg

Tablets

Dogs

Oral use

Croatia

| Boehringer Ingelheim Animal Health France SCS, |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS,

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 250 mg, tablete za pse

Doxycycline

250 mg

Tablets

Dogs

Oral use

Czechia

| Boehringer Ingelheim Animal Health France SCS, |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS,

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 100 mg tablety

Doxycycline

100 mg

Tablets

Dogs

Oral use

Czechia

| Boehringer Ingelheim Animal Health France SCS, |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS,

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 20 mg tablety

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Denmark

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 København Ø |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 København Ø

Denmark

Ronaxan Vet.

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Denmark

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 København Ø |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 København Ø

Denmark

Ronaxan Vet.

Doxycycline

100 mg

Tablets

Cats and dogs

Oral use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan comprimes 20

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan comprimes 100

Doxycycline

100 mg

Tablets

Dogs

Oral use

France

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan comprimes 250

Doxycycline

250 mg

Tablets

Dogs

Oral use

Germany

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| Germany |

Boehringer Ingelheim Vetmedica GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ronaxan 100

Doxycycline

100 mg

Tablets

Dogs

Oral use

Greece

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan, Δισκία 20 mg/tab

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Greece

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan, Δισκία 100 mg/tab

Doxycycline

100 mg

Tablets

Dogs

Oral use

Greece

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan, Δισκία 250 mg/tab

Doxycycline

250 mg

Tablets

Dogs

Oral use

Ireland

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| Germany |

Boehringer Ingelheim Vetmedica GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ronaxan 100 mg Tablet

Doxycycline

100 mg

Tablets

Dogs

Oral use

Ireland

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| Germany |

Boehringer Ingelheim Vetmedica GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ronaxan 20 mg Tablet

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Italy

| Boehringer Ingelheim Animal Health Italia S.p.A |
| --- |
| Via Lorenzini n.8 |
| Milano — 20139 |
| Italy |

Boehringer Ingelheim Animal Health Italia S.p.A

Via Lorenzini n.8

Milano — 20139

Italy

Ronaxan, 20 mg compresse per cani e gatti

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Italy

| Boehringer Ingelheim Animal Health Italia S.p.A |
| --- |
| Via Lorenzini n.8 |
| Milano — 20139 |
| Italy |

Boehringer Ingelheim Animal Health Italia S.p.A

Via Lorenzini n.8

Milano — 20139

Italy

Ronaxan, 100 mg compresse per cani

Doxycycline

100 mg

Tablets

Dogs

Oral use

Italy

| Boehringer Ingelheim Animal Health Italia S.p.A |
| --- |
| Via Lorenzini n.8 |
| Milano — 20139 |
| Italy |

Boehringer Ingelheim Animal Health Italia S.p.A

Via Lorenzini n.8

Milano — 20139

Italy

Ronaxan, 250 mg compresse per cani

Doxycycline

250 mg

Tablets

Dogs

Oral use

Lithuania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 20, tabletės

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Lithuania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 100, tabletės

Doxycycline

100 mg

Tablets

Cats and dogs

Oral use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium SA |
| --- |
| Arianelaan 16 |
| 1200 Brussel |
| Belgium |

Boehringer Ingelheim Animal Health Belgium SA

Arianelaan 16

1200 Brussel

Belgium

Ronaxan 20 mg

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Luxembourg

| Boehringer Ingelheim Animal Health Belgium SA |
| --- |
| Arianelaan 16 |
| 1200 Brussel |
| Belgium |

Boehringer Ingelheim Animal Health Belgium SA

Arianelaan 16

1200 Brussel

Belgium

Ronaxan 100 mg

Doxycycline

100 mg

Tablets

Dogs

Oral use

Malta

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan tablets 100

Doxycycline

100 mg

Tablets

Dogs

Oral use

Malta

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan tablets 20

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Norway

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Ronaxan Vet

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Norway

| Boehringer Ingelheim Animal Health Nordics A/S |
| --- |
| Strødamvej 52 |
| 2100 Copenhagen |
| Denmark |

Boehringer Ingelheim Animal Health Nordics A/S

Strødamvej 52

2100 Copenhagen

Denmark

Ronaxan Vet

Doxycycline

100 mg

Tablets

Cats and dogs

Oral use

Portugal

| Boehringer Ingelheim Animal Health, Unipessoal, Lda. |
| --- |
| Avenida de Pádua, no 11 |
| 1800-294 Lisboa |
| Portugal |

Boehringer Ingelheim Animal Health, Unipessoal, Lda.

Avenida de Pádua, no 11

1800-294 Lisboa

Portugal

Ronaxan 20 mg comprimidos para cães e gatos

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Portugal

| Boehringer Ingelheim Animal Health, Unipessoal, Lda. |
| --- |
| Avenida de Pádua, no 11 |
| 1800-294 Lisboa |
| Portugal |

Boehringer Ingelheim Animal Health, Unipessoal, Lda.

Avenida de Pádua, no 11

1800-294 Lisboa

Portugal

Ronaxan 100 mg comprimidos para cães

Doxycycline

100 mg

Tablets

Dogs

Oral use

Portugal

| Boehringer Ingelheim Animal Health, Unipessoal, Lda. |
| --- |
| Avenida de Pádua, no 11 |
| 1800-294 Lisboa |
| Portugal |

Boehringer Ingelheim Animal Health, Unipessoal, Lda.

Avenida de Pádua, no 11

1800-294 Lisboa

Portugal

Ronaxan 250 mg comprimidos para cães

Doxycycline

250 mg

Tablets

Dogs

Oral use

Romania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 20 mg Tablet

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Romania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 100 mg Tablet

Doxycycline

100 mg

Tablets

Dogs

Oral use

Romania

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 250 mg Tablet

Doxycycline

250 mg

Tablets

Dogs

Oral use

Slovakia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 20 mg tablety

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Slovakia

| Boehringer Ingelheim Animal Health France SCS |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| France |

Boehringer Ingelheim Animal Health France SCS

29 Avenue Tony Garnier

69007 Lyon

France

Ronaxan 100 mg tablet

Doxycycline

100 mg

Tablets

Dogs

Oral use

Spain

| Boehringer Ingelheim Animal Health España S.A.U. |
| --- |
| C/Prat de la Riba, 50 |
| Sant Cugat del Valles Barcelona 08174 |
| Spain |

Boehringer Ingelheim Animal Health España S.A.U.

C/Prat de la Riba, 50

Sant Cugat del Valles Barcelona 08174

Spain

Ronaxan 20 mg comprimidos

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Spain

| Boehringer Ingelheim Animal Health España S.A.U. |
| --- |
| C/Prat de la Riba, 50 |
| Sant Cugat del Valles Barcelona 08174 |
| Spain |

Boehringer Ingelheim Animal Health España S.A.U.

C/Prat de la Riba, 50

Sant Cugat del Valles Barcelona 08174

Spain

Ronaxan 100 mg comprimidos

Doxycycline

100 mg

Tablets

Dogs

Oral use

Sweden

Boehringer Ingelheim Animal Health Nordics A/S, Strødamvej 52, 2100 Copenhagen Ø, Denmark

Ronaxan vet.

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

Sweden

Boehringer Ingelheim Animal Health Nordics A/S, Strødamvej 52, 2100 Copenhagen Ø, Denmark

Ronaxan vet.

Doxycycline

100 mg

Tablets

Cats and dogs

Oral use

The Netherlands

| Boehringer Ingelheim Animal Health Netherlands B.V. |
| --- |
| Comensiusstraat 6 |
| 1817 MS Alkmaar |
| The Netherlands |

Boehringer Ingelheim Animal Health Netherlands B.V.

Comensiusstraat 6

1817 MS Alkmaar

The Netherlands

Ronaxan 100 mg, tablet voor honden en katten

Doxycycline

100 mg

Tablets

Cats and dogs

Oral use

The Netherlands

| Boehringer Ingelheim Animal Health Netherlands B.V. |
| --- |
| Comensiusstraat 6 |
| 1817 MS Alkmaar |
| The Netherlands |

Boehringer Ingelheim Animal Health Netherlands B.V.

Comensiusstraat 6

1817 MS Alkmaar

The Netherlands

Ronaxan 20 mg, tablet voor honden en katten

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

United Kingdom (Northern Ireland) 1
   (1)

| Boehringer Ingelheim Animal Health UK Ltd, |
| --- |
| Ellesfield Avenue, Bracknell |
| Berkshire |
| RG12 8YS |
| United Kingdom |

Boehringer Ingelheim Animal Health UK Ltd,

Ellesfield Avenue, Bracknell

Berkshire

RG12 8YS

United Kingdom

Ronaxan 100 mg Tablet

Doxycycline

100 mg

Tablets

Dogs

Oral use

United Kingdom (Northern Ireland) (1)

| Boehringer Ingelheim Animal Health UK Ltd, |
| --- |
| Ellesfield Avenue, Bracknell |
| Berkshire |
| RG12 8YS |
| United Kingdom |

Boehringer Ingelheim Animal Health UK Ltd,

Ellesfield Avenue, Bracknell

Berkshire

RG12 8YS

United Kingdom

Ronaxan 20 mg Tablet

Doxycycline

20 mg

Tablets

Cats and dogs

Oral use

---

(1)  For the United Kingdom, as from 1 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

---

ANNEX II

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration and marketing authorisation holders in the Member States

ANNEX IIA

List of authorised veterinary medicinal products recommended for variation of the marketing authorisations

| Member State EU/EEA | Marketing authorisation holders | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Bela-pharm GmbH & Co. KG |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Member State EU/EEA

Marketing authorisation holders

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E, Injektionslösung für Rind, Pferd, Schwein und Hund

Retinolpalmitat

All-rac alpha tocopherolacetat

Colecalciferol

176,47  mg (300 000 IU)

50 mg

2,5  mg (100 000 IU)

Solution for injection

Cattle, horses, pigs, dogs

For intramuscular and subcutaneous use

Austria

| Richter Pharma AG |
| --- |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Vitasol AD3E Injektionslösung für Tiere

Vitamin A als Retinol Palmitat

Vitamin D3 als colecalciferol

Vitamin E als all-rac-α-tocopherolacetat

50 000 I.E.

25 000 I.E.

20 mg

Solution for injection

Cattle, horses, pigs, dogs

For subcutaneous, intramuscular, in large animals also intravenous (slow, body warm) injection

Austria

| Richter Pharma AG |
| --- |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Vitasol AD3EC — Injektionslösung für Tiere

Vitamin A als Retinol Palmitat

Vitamin D3 als Colecalciferol

all-rac-α-Tocopherolacetat (Vit. E)

Ascorbinsäure (Vit. C)

50 000 I.E.

25 000 I.E.

30 mg

100 mg

Solution for injection

Cattle, horses, pigs, dogs

For intramuscular and subcutaneous use

Belgium

| Zoetis Belgium s.a. |
| --- |
| Rue Laid Burniat, 1 |
| B-1348 Louvain-La-Neuve |
| Belgium |

Zoetis Belgium s.a.

Rue Laid Burniat, 1

B-1348 Louvain-La-Neuve

Belgium

Duphafral AD3E

Vitamin A

Vitamin D3

Vitamin E

500 000 IU

50 000 IU

50 mg

Solution for injection

Cattle, horses, sheep, pigs

For intramuscular use

Belgium

| V.M.D. n.v. |
| --- |
| Hoge Mauw 900 |
| B-2370 Arendonk |
| Belgium |

V.M.D. n.v.

Hoge Mauw 900

B-2370 Arendonk

Belgium

Vitamine A+D3+E

Vitaminum A

Colecalciferolum

Alphatocopheroli acetas

50 000 IU

25 000 IU

20 mg

Solution for injection

Calf, sow, piglets

For intramuscular use

Bulgaria

| Asklep-Pharma Ltd |
| --- |
| Lyulin 7, bl. 711A, shop 3 |
| Sofia |
| Bulgaria |

Asklep-Pharma Ltd

Lyulin 7, bl. 711A, shop 3

Sofia

Bulgaria

Norovit

Vitamin A palmitate, Cholecalciferol (Vitamin D3), Vitamin E acetate, Thiamine hydrochloride (Vitamin B1), Riboflavin sodium phosphate (Vitamin B2), Pyridoxine hydrochloride (Vitamin B6), Nicotinamide, Dexpanthenol, Cyanocobalamin (Vitamin B12)

15 000 IU

25 μg

20 mg

10 mg

5 mg

3 mg

35 mg

25 mg

25 μg

Solution for injection

Cattle, horses, pigs, sheep

For intramuscular and subcutaneous use

Bulgaria

| Biovet JSC |
| --- |
| 39, Petar Racov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39, Petar Racov Str.

4550 Peshtera

Bulgaria

Vialiton solution for injection

Vitamin A; Vitamin D3; Vitamin Е

20 mg/ml (50 000 IU) 0,625  mg/ml (25 000  IU)

20 mg/ml

Solution for injection

Cattle, calves, chickens, horses, pigs, dogs, cats

For intramuscular, subcutaneous and oral use

Bulgaria

| Vetprom AD |
| --- |
| 26, Otez Paissij Str. |
| 2400 Radomir |
| Bulgaria |

Vetprom AD

26, Otez Paissij Str.

2400 Radomir

Bulgaria

Vitamin AD3E solutio pro injectionibus

Vitamin A, Cholecalciferol, Alpha — Tocopheryl Acetate (Vit. E)

1 500 000 IU/100 ml

2 000 000 IU/100 ml

1 g/100 ml

Solution for injection

Cattle, sheep, goats, horses, pigs, piglets

For intramuscular, subcutaneous and oral use

Bulgaria

| Provet S. A. |
| --- |
| 77, Posidonos Avenue |
| 174 55 Alimos, |
| Attiki |
| Greece |

Provet S. A.

77, Posidonos Avenue

174 55 Alimos,

Attiki

Greece

Zingul inj.

Vitamin A (as palmitat);

Vitamin D3;

Vitamin E (as acetat)

50 000 IU/ml

25 000 IU/ml

50 mg/ml

Solution for injection

Cattle, goats, horses, pigs, sheep

For intramuscular use

Croatia

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E pro injectione, otopina za injekciju, za konje, goveda, svinje i pse

Retinol (vitamin A) palmitate,

All-rac alpha tocopheryl acetate

Cholecalciferol

176,47  mg (300 000 IU)

50 mg

100 mg

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Croatia

| Krka — Farma d.o.o. |
| --- |
| Radnička cesta 48 |
| 10000 Zagreb |
| Croatia |

Krka — Farma d.o.o.

Radnička cesta 48

10000 Zagreb

Croatia

Vitamin AD3E, emulzija za injekciju, goveda, ovce, koze, konji, svinje, kunići, psi, mačke

Vitamin A (retinol) palmitate, cholecalciferol and all-rac-α-Tocopheryl acetate

50 000 IU/ml

25 000 IU/ml

20 mg/ml

Emulsion for injection

Cattle, sheep, goats, horses, pigs, rabbits, dogs, cats

For intramuscular and subcutaneous use

Cyprus

| Fatro S.p.A. |
| --- |
| Via Emilia 285 |
| 40064 Ozzano dell’Emilia |
| Bologna |
| Italy |

Fatro S.p.A.

Via Emilia 285

40064 Ozzano dell’Emilia

Bologna

Italy

Adecon injection

Ενέσιμο διάλυμα για βοοειδή, άλογα, χοίρους, πρόβατα και αίγες

Retinol acetate (Vitamin A)

Vitamin D3 Vitamin E

100 000 IU /ml

25 000 IU /ml

100 mg/ml

Solution for injection

Cattle, horses, pigs, sheep, goats

Intramuscular (may be administered orally)

Cyprus

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Belavit AD3E, ενέσιμο διάλυμα για άλογα, βοοειδή, χοίρους και σκύλους

Retinol palmitate

Vitamin D3 Vitamin E acetate

176,47  mg

100 mg per ml

50 mg per ml

Solution for injection

Cattle, pigs, horses, dogs

For subcutaneous or intramuscular use

Czechia

| Kela NV |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela NV

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Adedri-kel injekční roztok

Retinol+

Colecalciferol

100 000 IU +50 000 IU

Solution for injection

Horses, cattle, pigs, sheep, goats, dogs, cats

For intramuscular and subcutaneous use

Czechia

| Bioveta, a. s. |
| --- |
| Komenského 212 |
| 683 23 Ivanovice na Hané |
| Czech Republic |

Bioveta, a. s.

Komenského 212

683 23 Ivanovice na Hané

Czech Republic

ADE — vit injekční roztok

Retinol+

Tocopherol+

Ergocalciferol

1 ml:

100 000 IU + 30 mg + 100 000 IU

Solution for injection

Cattle, dogs, goats, horses, pigs, rabbits, sheep

For intramuscular use

Czechia

| Pharmagal Ltd. |
| --- |
| Murgašova 5, |
| 949 01 Nitra |
| Slovak Republic |

Pharmagal Ltd.

Murgašova 5,

949 01 Nitra

Slovak Republic

Triavit injekční roztok

Retinol+

Tocopherol+

Colecalciferol

1 ml:

100 000 IU

50 mg

50 000 IU

Solution for injection

Horses, cattle, pigs, sheep, dogs, rabbits, poultry

For intramuscular and subcutaneous use

Czechia

| Alfasan International B.V. |
| --- |
| Kuipersweg 9 |
| Woerden |
| Utrecht |
| The Netherlands |

Alfasan International B.V.

Kuipersweg 9

Woerden

Utrecht

The Netherlands

Vitamin AD3E Alfasan injekční roztok

Retinol+

Tocopherol+

Colecalciferol

1 ml:

300 000 IU

50 mg

100 000 IU

Solution for injection

Cattle, goats, horses, pigs, sheep

For intramuscular and subcutaneous use

Estonia

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E bela-pharm

Retinol+

Tocopherol+

Colecalciferol

1ml:

300 000 IU (176,47  mg)

50 mg

100 000 IU (100 mg)

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Estonia

| Alfasan International B.V. |
| --- |
| Kuipersweg 9 |
| Woerden |
| Utrecht |
| The Netherlands |

Alfasan International B.V.

Kuipersweg 9

Woerden

Utrecht

The Netherlands

Vitamin AD3E forte

Retinol+

Tocopherol+

Colecalciferol

1ml:

500 000 IU+

50 mg+

75 000 IU

Solution for injection

Cattle, cats, dogs, goats, horses, sheep

For intramuscular and subcutaneous use

Estonia

| Interchemie Werken De Adelaar Eesti AS |
| --- |
| Vanapere tee 14, Püünsi küla |
| Viimsi vald, Harju maakond |
| 74013 |
| Estonia |

Interchemie Werken De Adelaar Eesti AS

Vanapere tee 14, Püünsi küla

Viimsi vald, Harju maakond

74013

Estonia

Vitol-140

Retinol+

Tocopherol+

Colecalciferol

1 ml:

80 000 IU+

20 mg+

40 000 IU

Solution for injection

Cattle, horses, pigs, sheep

For intramuscular use

France

| Virbac |
| --- |
| 1ere Avenue 2065 M — L.I.D. |
| 06516 Carros Cedex |
| France |

Virbac

1ere Avenue 2065 M — L.I.D.

06516 Carros Cedex

France

Ad-Ject

Retinol palmitate,

Cholecalciferol,

Alpha-tocopherol (as acetate)

500 000 IU/ml

75 000 IU/ml

45,6  mg/ml

Solution for injection

Cattle, sheep, pigs

For intramuscular use

France

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Belavit AD3E Solution for injection for horses, cattle, pigs and dogs

Retinol palmitate,

Cholecalciferol concentrate (oily form),

All-rac-alpha-tocopheryl acetate

176,47  mg/ml

100 mg/ml

50 mg/ml

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

France

| Dopharma France |
| --- |
| 23, Rue du Prieuré |
| Saint Herblon |
| 44150 Vair sur Loire |
| France |

Dopharma France

23, Rue du Prieuré

Saint Herblon

44150 Vair sur Loire

France

Cofavit 500

Retinol (as propionate),

Cholecalciferol,

Alpha-tocopherol (as acetate)

500 000 IU/ml

75 000 IU/ml

45,55  mg/ml

Solution for injection

Cattle, sheep, goats, pigs, rabbits

For intramuscular and subcutaneous use

France

| Laboratoires Biové |
| --- |
| 3 Rue de Lorraine |
| 62510 Arques |
| France |

Laboratoires Biové

3 Rue de Lorraine

62510 Arques

France

Trivitase

Retinol palmitate,

Cholecalciferol,

Alpha-tocopherol (as acetate)

500 000 IU/ml

75 000 IU/ml

50 mg/ml

Solution for injection

Cattle, sheep, goats, pigs

For intramuscular use

Germany

| Serumwerk Bernburg AG |
| --- |
| Hallesche Landstrasse 105b |
| 06406 Bernburg |
| Germany |

Serumwerk Bernburg AG

Hallesche Landstrasse 105b

06406 Bernburg

Germany

Ursovit AD3EC, wässrig pro inj.

Retinol palmitate

Colecalciferol

Alpha-tocopherol acetate

Ascorbic acid

1 ml:

30 mg (50 000 IU)

0,125  mg

30 mg

100 mg

Solution for injection

Cattle, cats, horses, minks, pigs, sheep, goats, rabbits, dogs

For intramuscular and subcutaneous use

Germany

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E pro injectione

Retinol palmitate

(Vitamin A)

All-rac alpha tocopheryl acetate

Cholecalciferol

176,47  mg (300 000 IU)

50 mg

100 mg

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Germany

| AniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

AniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Vitamin ADE aniMedica

Retinol palmitate

(Vitamin A)

Colecalciferol

All-rac-alpha-Tocopherolacetat

176,47  mg (300 000 IU)

2,5  mg

50 mg

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs

For intramuscular use

Greece

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Belavit AD3E, solution for injection for horses, cattle, pigs, and dogs

Vitamin A

Vitamin D3 Vitamin E acetate

176,47  mg/ml

100 mg/ml

50 mg/ml

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Greece

| A.Nikolakopoulos A.E, |
| --- |
| 115 Galatsiou Avenue, |
| Galatsi 11146 |
| Athens |
| Greece |

A.Nikolakopoulos A.E,

115 Galatsiou Avenue,

Galatsi 11146

Athens

Greece

Bremervit AD3E

Vitamin A

Vitamin D3 Vitamin E acetate

(300 000  IU+ 100 000 IU+50 mg)/ml

Solution for injection

Cattle, horses, pregnant sow, calves, foals, pigs, sheep, goats, piglets, lambs

For intramuscular use

Greece

| Erfar SA |
| --- |
| Altani & Mikras Asias 2 St., |
| 15351 Pallini Attikis |
| Athens |
| Greece |

Erfar SA

Altani & Mikras Asias 2 St.,

15351 Pallini Attikis

Athens

Greece

Adepur

Vitamin A Vitamin D3 Vitamin E acetate

(50 000 IU +25 000 IU + 20 mg)/ml

Solution for injection

Cattle, horses, pigs, sheep, goats, calves, lambs, piglets

For intramuscular use

Greece

| Hellafarm AE |
| --- |
| 1st km Paiania-Markopoulou Avenue |
| 19002 Paiania |
| Attiki |
| Athens |
| Greece |

Hellafarm AE

1st km Paiania-Markopoulou Avenue

19002 Paiania

Attiki

Athens

Greece

Labiasol AD3E-500

Vitamin A Propionate Vitamin D3 Vitamin E

(500 000  IU +75 000  IU+ 50 IU)/ml

Suspension for injection

Cattle, goats, sheep, pigs, horses

For intramuscular use

Greece

| Intervet Hellas S.A. |
| --- |
| 63, Agiou Dimitriou str, |
| GR-174 56 Alimos, Athens |
| Greece |

Intervet Hellas S.A.

63, Agiou Dimitriou str,

GR-174 56 Alimos, Athens

Greece

Turlin AD3E

Vitamin A Palmitate

Vitamin D3

Vitamin E

(50 000  IU +25 000  IU + 20 mg)/ml

Solution for injection

Cattle, horses, pigs, goats, sheep, poultry

For intramuscular and subcutaneous use

Greece

| Hellafarm AE |
| --- |
| 1st km Paiania-Markopoulou Avenue |
| 19002 Paiania |
| Attiki |
| Athens |
| Greece |

Hellafarm AE

1st km Paiania-Markopoulou Avenue

19002 Paiania

Attiki

Athens

Greece

Vitamin AD3E/New Vet

Vitamin A Palmitate

Vitamin D3

Vitamin E

(50 000 IU+25 000 IU+ 20 mg)/ml

Solution for injection

Cattle, calves, pigs, horses, sheep, goats, piglets

For intramuscular use

Greece

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

Vitamine AD3E/Eurovet

Vitamin A Palmitate

Vitamin D3

Vitamin E

(80 000  IU +40 000  IU + 20 mg)/ml

Solution for injection

Cattle, horses, sheep, goats, pigs, dogs, cats

For intramuscular and subcutaneous use

Greece

| Anafasis LTD |
| --- |
| 3 Santorinis St, |
| Pallouriotissa |
| 1048 Nicosia |
| Cyprus |

Anafasis LTD

3 Santorinis St,

Pallouriotissa

1048 Nicosia

Cyprus

Vitamins AD3E/Anafasis

Vitamin A palmitate

Vitamin D3

Vitamin E

(50 000 IU +25 000 IU + 20 mg)/ml

Solution for injection

Cattle, horses, pigs, sheep, goats

For intramuscular, intravenous use

Greece

| Anafasis LTD |
| --- |
| 3 Santorinis St, |
| Pallouriotissa |
| 1048 Nicosia |
| Cyprus |

Anafasis LTD

3 Santorinis St,

Pallouriotissa

1048 Nicosia

Cyprus

Vitamins AD3E/Anafasis

Vitamin A palmitate Vitamin D3

Vitamin E

(300 000 IU+ 100 000 IU + 50 mg)/ml

Solution for injection

Cattle, horses, pigs, sheep, goats, dogs

For intramuscular, intravenous use

Greece

| Provet S. A. |
| --- |
| 77 Posidonos Avenue |
| 174 55 Alimos |
| Attiki |
| Greece |

Provet S. A.

77 Posidonos Avenue

174 55 Alimos

Attiki

Greece

Zingul

Vitamin A (as palmitate)

Vitamin D3

Vitamin E

(50 000 IU+25 000 IU + 50 mg)/ml

Solution for injection

Cattle, horses, pigs, sheep, goats

For intramuscular use

Hungary

| Kela NV |
| --- |
| Sint Lenaartseweg 48 |
| 2320 Hoogstraten |
| Belgium |

Kela NV

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Neovit AD3E injekció A.U.V.

Vitamin A,

cholecalciferol, alpha tocopherol acetate

100 000 IU/ml

50 000  IU/ml

5 mg/ml

Solution for injection

Cattle, cats, dogs, goats, horses, pigs, sheep

For intramuscular and subcutaneous use

Hungary

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Belavit AD3E 176,47 /2,5 /50 mg/ml oldatos injekció lovak, szarvasmarhák, sertések, kutyák számára A.U.V.

Vitamin A, vitamin D3, vitamin E

300 000 IU/ml

100 000 IU/ml

50 mg/ml

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Hungary

| Bio-Vet Kft. |
| --- |
| 4487 Tiszatelek, |
| Kossuth u. 151. |
| Hungary |

Bio-Vet Kft.

4487 Tiszatelek,

Kossuth u. 151.

Hungary

Ferriade injekció A.U.V.

Iron-dextran, vitamin A,

vitamin D3, vitamin E

100 mg/ml

10 000 IU/ml

1 000 IU/ml

10 mg/ml

Solution for injection

Calves, lambs, piglets

For intramuscular and subcutaneous use

Hungary

| UNIVET Ltd. |
| --- |
| Tullyvin, Cootehill, Co. Cavan, |
| Ireland |

UNIVET Ltd.

Tullyvin, Cootehill, Co. Cavan,

Ireland

Multivitamines oldatos injekció A.U.V.

Vitamin A, vitamin B1, B2, B6, B12, D3, E, nicotinamide, D-panthenol

1 ml:

15 000 IU

10 mg

5 mg

3 mg

50 μg

1 000 IU

10 mg

35 mg

25 mg

Solution for injection

Cattle, pigs

For intramuscular use

Hungary

Bremer Pharma GmbH Werkstrasse 42, 34414 Warburg, Germany

Vitamin AD3E injekció A.U.V.

Vitamin A,

cholecalciferol, vitamin E

50 000 IU/ml,

25 000 IU/ml,

20 mg/ml

Solution for injection

Horses, cattle, pigs, dogs, cats

For intramuscular use

Iceland

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E pro injectione

Retinol Palmitate, Colecalciferolum INN, all-rac-alpha-Tocopheryl Acetate

176,47  mg/ml

100 mg/ml

50 mg/ml

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Ireland

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Belavit AD3E, solution for injection for horses, cattle, pigs, and dogs

Retinol palmitate (Vitamin A)

Vitamin D3 Vitamin E acetate

176,47  mg/ml (300 000 IU)

100 mg/ml

50 mg/ml

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Ireland

Chem-Pharm, Ballyvaughan, Co. Clare, Ireland

Multivitamin Injection

Vitamin A Palmitate

Vitamin D3 (Cholecalciferol)

Vitamin E (Alpha tocopheryl acetate)

Vitamin B1 (Thiamine hydrochloride)

Vitamin B2 (Riboflavin Sodium Phosphate)

Vitamin B6 (Pyridoxine)

Nicotinamide

Dexpanthenol

Vitamin B12 (Cyanocobalamin)

1 ml:

15 000 IU

25 μg

20 mg

10 mg

5 mg

3 mg

35 mg

25 mg

25 μg

Solution for injection

Cattle, sheep, pigs

For intramuscular and subcutaneous use

Italy

| Ceva Salute Animale S.p.A. |
| --- |
| Viale Colleoni 15 |
| 20864 Agrate Brianza (MB) |
| Italy |

Ceva Salute Animale S.p.A.

Viale Colleoni 15

20864 Agrate Brianza (MB)

Italy

Fosforilene Plus, soluzione iniettabile per vitelli, equini, suini, agnelli

Phosphorylcholamine

retinol palmitate

d, l-alpha-tocopheryl acetate

sodium selenite

40 mg/ml

10 000 IU/ml

30 mg/ml

0,4  mg/ml

Solution for injection

Calves, horses, pigs, lambs

For intramuscular use

Italy

| Fatro S.p.A. |
| --- |
| Via Emilia 285 |
| 40064 Ozzano dell’Emilia |
| Bologna |
| Italy |

Fatro S.p.A.

Via Emilia 285

40064 Ozzano dell’Emilia

Bologna

Italy

Adecon, soluzione iniettabile per bovini, equini, suini, ovi-caprini

Retinol acetate (vitamin A)

cholecalciferol (vitamin D3)

alpha-tocopherol equal to alpha-tocopherol acetate (vitamin E)

100 000 IU/ml;

25 000 IU/ml; 100 mg/ml

Solution for injection

Cattle, horses, pigs, sheep, goats

For intramuscular use (may be administered orally)

Italy

| Ceva Salute Animale S.p.A. |
| --- |
| Viale Colleoni 15 |
| 20864 Agrate Brianza (MB) |
| Italy |

Ceva Salute Animale S.p.A.

Viale Colleoni 15

20864 Agrate Brianza (MB)

Italy

Adisole A-D-E, soluzione iniettabile per bovini, suini, ovini, equini

Vitamin A palmitate

vitamin D 3

vitamin E acetate

100 000 IU/ml

25 000 IU/ml

100 mg/ml

Solution for injection

Cattle, pigs, sheep, horses

For intramuscular use

Italy

| Fatro S.p.A. |
| --- |
| Via Emilia 285 |
| 40064 Ozzano dell’Emilia |
| Bologna |
| Italy |

Fatro S.p.A.

Via Emilia 285

40064 Ozzano dell’Emilia

Bologna

Italy

Idrade, emulsione iniettabile per bovini, equini, suini, ovini

Retinol propionate (vit. A)

cholecalciferol (vit. D3)

d, l-alpha tocopherol acetate (vit. E)

500 000 IU

75 000 IU

50 mg

Emulsion for injection

Cattle, horses, pigs, sheep

For intramuscular and subcutaneous use

Italy

| Izo S.r.l. a socio unico |
| --- |
| Via San Zeno 99/A |
| 25124 Brescia |
| Italy |

Izo S.r.l. a socio unico

Via San Zeno 99/A

25124 Brescia

Italy

Izotrevit, soluzione iniettabile per bovini, ovini e suini

Retinol

Ergocalciferol

d-l-α-tocopherol

500 000 IU/ml

75 000 IU/ml

50 IU/ml

Solution for injection

Cattle, pigs, sheep

For deep intramuscular or intraruminal use: cattle

Intramuscular use: pigs

Subcutaneous use: sheep subcutaneously

Italy

| Labiana Life Sciences S.A. |
| --- |
| Venus, 26 |
| Terrassa |
| 08228 Barcelona |
| Spain |

Labiana Life Sciences S.A.

Venus, 26

Terrassa

08228 Barcelona

Spain

Labhidro AD3E 100 N

Retinol acetate (vitamin A)

cholecalciferol (vitamin D3)

d-l alpha-tocopheril acetate (vitamin E)

10 000 000 IU/100 ml

5 000 000 IU/100 ml

10 g/100 ml

Solution for injection

Cattle, pigs, sheep, goats, horses

For intramuscular use

Italy

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E pro injectione, soluzione iniettabile per equini, bovini, suini e cani

Retinol palmitate (Vitamin A)

all-rac alpha tocopheryl acetate (Vitamin E)

Cholecalciferol (Vitamin D)

176,47  mg (300 000 IU)

50 mg

2,5  mg (100 000 IU)

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Latvia

| Krka, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Vitamin AD3E Krka injection emulsija injekcijām liellopiem, zirgiem, cūkām, aitām, kazām, trušiem,

suņiem un kaķiem

Retinyl palmitate (Vitamin A);

Cholecalciferol (vitamin D3);

Tocopheryl acetate (vitamin E)

50 000 IU/ml

25 000 IU/ml

20 mg/ml

Emulsion for injection

Cattle, horses, pigs, sheep, goats, rabbits, dogs, cats, foals, piglets, calves, goat kids, lambs

For intramuscular and subcutaneous use

Latvia

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E pro injectione šķīdums injekcijām zirgiem, liellopiem, cūkām un suņiem

Retinol palmitate

All-rac alpha tocopheryl acetate

Oily solution of cholecalciferol 100.00 mg

(contains 2.5 mg cholecalciferol; equivalent to 100,000 I.U. Vitamin D3)

176,47  mg (300 000 IU)

50 mg

2,5  mg (100 000 IU)

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Latvia

| Richter Pharma AG |
| --- |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Vitasol AD3EC šķīdums injekcijām zirgiem, liellopiem, cūkām un suņiem

Vitamin A (retinyl propionate), Vitamin D3 (cholecalciferol), Vitamin E (DL-α-tocopheryl acetate), Vitamin C (ascorbinic acid)

50 000 IU

25 000 IU

30 mg

100 mg

Solution for injection

Horses, cattle, pigs, dogs

For intramuscular and subcutaneous use

Lithuania

| UAB Interchemie werken |
| --- |
| De Adelaar LT |
| Vinčų g. 3-48 |
| 46297 Kaunas |
| Lithuania |

UAB Interchemie werken

De Adelaar LT

Vinčų g. 3-48

46297 Kaunas

Lithuania

Introvit, injekcinis tirpalas galvijams, arkliams, ožkoms, avims ir kiaulėms

Vit. A, retinol oil+ vit. D3, cholecalciferol+ vit.E, alpha-tocopherol acetate+vit.B1, thiamine hydrochloride+vit. B2, riboflavin sodium phosphate+vit. B6, pyridoxine hydrochloride+ vit. B12, cyanocobalamin+ dexpanthenol+ nicotinamide+ biotin+ choline chloride+ lysine hydrochloride+ DL-methionine

15 000 IU +7 500 IU + 20 mg + 10 mg + 5 mg + 3 mg + 60 μg + 25 mg + 50 mg + 125 μg +12,5  mg + 7 mg + 5 mg

Solution for injection

Cattle,

horses,

calves, foals, goats,

sheep,

lambs,

pigs

For intramuscular and subcutaneous use

Lithuania

| Bioveta, a. s. |
| --- |
| Komenského 212 |
| 683 23 Ivanovice na Hané |
| Czech Republic |

Bioveta, a. s.

Komenského 212

683 23 Ivanovice na Hané

Czech Republic

Multivit–Mineral, injekcinis tirpalas

Retinol + cholecalciferol + vitamin E + thiamine + riboflavin + pyridoxine + cyanocobalamin + dexpanthenol + nicotinic acid+ inositol + methionine + choline citrate + magnesium hypophosphite hexahydrate + cobalt chloride + copper sulfate + zinc sulfate

50 000 IU +25 000 IU + 4 mg + 10 mg +0,04  mg + 2 mg +0,01  mg + 2 mg + 5 mg + 2 mg + 5 mg + 5 mg + 1 mg +0,02  mg +0,1  mg +0,1  mg

Solution for injection

Cattle, horses, sheep, pigs, goats, dogs, chickens, turkeys, ducks, geese, pigeons, exotic birds

For intramuscular, subcutaneous and oral use

Lithuania

| Krka, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Vitamin AD3E Krka, injekcinė emulsija

Retinol palmitate

cholecalciferol

α-tocopheryl acetate

50 000 IU/ml

25 000 IU/ml

20 mg/ml

Emulsion for injection

Cattle, horses, pigs, sheep, goats, rabbits, dogs, cats

For intramuscular and subcutaneous use

Lithuania

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E, injekcinis tirpalas

Retinol palmitate+ Cholecalciferol+ α-tocopheryl acetate

176,47  mg (300 000  IU)

2,5  mg (100 000 IU)

50 mg

Solution for injection

Cattle, calves, pigs, piglets, weaned piglets, horses, dogs

For intramuscular and subcutaneous use

Lithuania

| UAB Interchemie werken |
| --- |
| De Adelaar LT |
| Vinčų g. 3-48 |
| 46297 Kaunas |
| Lithuania |

UAB Interchemie werken

De Adelaar LT

Vinčų g. 3-48

46297 Kaunas

Lithuania

Vitol-140, injekcinis tirpalas

Retinol palmitate (vit. A)+ cholecalciferol (vit. D3) + alpha-tocopherol acetate (vit. E)

1 ml:

80 000 IU+

40 000 IU+

20 mg

Solution for injection

Cattle, calves, sheep, goats, horses, pigs, dogs, cats

For intramuscular and subcutaneous use

Lithuania

| Dopharma B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| The Netherlands |

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Vitol-Ject Forte, injekcinis tirpalas

Retinol propionate + cholecalciferol + thiamine hydrochloride+

riboflavin sodium phosphate+

pyridoxine hydrochloride+

cyanocobalamin+

ascorbic acid+

α-tocopherol acetate+

D-panthenol+

nicotinamide

50 000 IU+

25 000 IU+

2,5  mg+

2 mg+

1,25  mg+

3 μg+

2 mg+

4 mg+

3 mg+

12,5  mg

Solution for injection

All animals

For intramuscular use

Malta

| Fatro S.p.A. |
| --- |
| Via Emilia 285 |
| 40064 Ozzano dell’Emilia |
| Bologna |
| Italy |

Fatro S.p.A.

Via Emilia 285

40064 Ozzano dell’Emilia

Bologna

Italy

Adecon,

solution for injection for cattle, horses, pigs, sheep and goats

Retinol acetate, Cholecalciferol, α- tocopherol

100 000  IU

25 000 IU

100 mg

Solution for injection

Cattle, goats, horses, pigs, sheep

For Intramuscular use or oral administration

Malta

| Interchemie werken ‘De Adelaar’ B.V. |
| --- |
| Metaalweg 8, |
| 5404 CG Venray |
| The Netherlands |

Interchemie werken ‘De Adelaar’ B.V.

Metaalweg 8,

5404 CG Venray

The Netherlands

Introvit

Retinol palmitate, cholecalciferol, α-tocopherol acetate, thiamine hydrochloride, riboflavine sodium phosphate, pyridoxine hydrochloride, cyanocobalamin, Dexpanthenol, Nicotinamide, Biotin, Choline chloride, Lysine hydrochloride, DL- Methionine

15 000  IU,

7 500  IU,

20 mg,

10 mg,

5 mg,

3 mg,

60 μg,

25 mg,

50 mg,

125 mcg,

12,5  mg,

7 mg,

5 mg

Solution for injection

Cattle, calves, foals, goats, horses, lambs, pigs, sheep

For intravenous or subcutaneous use

Malta

| Labiana Life Sciences S.A |
| --- |
| Carrer de Venus, 26 |
| 08228 Terrassa (Barcelona) |
| Spain |

Labiana Life Sciences S.A

Carrer de Venus, 26

08228 Terrassa (Barcelona)

Spain

Labhidro AD3E Injectable

Vitamin A, Vitamin D3, Vitamin E (all-rac-α-tocopheryl acetate)

500 000 UI,

75 000 UI,

50 mg

Solution for injection

Cattle, goats, horses, pigs, sheep

For intramuscular use

Malta

| Labiana Life Sciences S.A |
| --- |
| Carrer de Venus, 26 |
| 08228 Terrassa (Barcelona) |
| Spain |

Labiana Life Sciences S.A

Carrer de Venus, 26

08228 Terrassa (Barcelona)

Spain

NOV-A-VIT 500

Vitamin A (retiinol propionate), cholecalciferol, All-rac-α-tocopheryl acetate (Vitamin E)

500 000 IU,

75 000 IU,

50 mg

Emulsion for injection

Cattle, goats, pigs, sheep

For intramuscular use

Malta

| Kepro B.V. |
| --- |
| Maagdenburgstraat 17 |
| 7421 ZA Deventer |
| The Netherlands |

Kepro B.V.

Maagdenburgstraat 17

7421 ZA Deventer

The Netherlands

Vita Flash Inj.

Vitamin A, Vitamin D3, Vitamin E acetate, Vitamin B1 HCl, Vitamin B2 phosphate sodium, Vitamin B3, Vitamin B6 HCl, Vitamin B12, Vitamin C, D-Panthenol

50 000 IU,

25 000 IU,

4 mg,

2,5  mg

2 mg,

12,5  mg,

1,25  mg,

30 μg,

2 mg,

3 mg

Solution for injection

Cattle, calves, foals, goats, horses, lambs, piglets, pigs, sheep

For intramuscular and subcutaneous use

Malta

Interchemie werken ‘'De Adelaar’' LT, Vincu g. 3-48, Kaunas, Lithuania

Vitol-140

Retinol palmitate, Cholecalciferol, α- tocopherol acetate

80 000  IU,

40 000  IU,

20 mg

Solution for injection

Cattle, calves, sheep, goats, horses, pigs, dogs, cats

For intramuscular or subcutaneous use

Norway

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Belavit AD3E vet

Retinol palmitate

Vitamin D3 Vitamin E acetate

176,47  mg (300 000 IU)

100 mg/ml

50 mg/ml

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Poland

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

Witamina AD3E 80/40/20 pro.inj.

Vitaminum A

Cholekalcyferolum

int-rac-alfa-Tocopherylis acetas

(80 000 IU+40 000  IU + 20 mg)/ml

Solution for injection

Horses, cattle, pigs, sheep, goats, dogs, cats

For intramuscular use

Portugal

| Zoetis Portugal, Lda |
| --- |
| Lagoas Park Edifício 10, |
| 2740-271 Porto Salvo |
| Portugal |

Zoetis Portugal, Lda

Lagoas Park Edifício 10,

2740-271 Porto Salvo

Portugal

Duphafral Multi

Vitamin A palmitate

Cholecalciferol (vitamin D3)

a-tocopherol acetate (vitamin E)

Thiamine hydrochloride (vitamin B1)

Riboflavin (vitamin B2 as sodium phosphate)

Pyridoxine hydrochloride (vitamin B6)

Cyanocobalamin (vitamin B12)

Nicotinamide

D-panthenol

15 000 IU

7 500 IU

20 mg

10 mg

5 mg

3 mg

20 μg

35 mg

25 mg

Solution for injection

Cats, dogs, visions

Newly born from: cattle, goats, horses, pigs, sheep

For intramuscular use

Portugal

| Divasa-Farmavic, S.A. |
| --- |
| Ctra. Sant Hipòlit, km 71 |
| 08503 Gurb — Vic |
| Barcelona |
| Spain |

Divasa-Farmavic, S.A.

Ctra. Sant Hipòlit, km 71

08503 Gurb — Vic

Barcelona

Spain

Polivit AD3E Solução Injectável para bovinos, suínos, ovinos, caprinos, equinos, cães e gatos. Vitamina A, Vitamina D3, Vitamina E

Vitamin A

Vitamin D3

Vitamin E

500 000 IU/ml

75 000 IU/ml

50 IU/ml

Solution for injection

Cattle, cats, dogs, goats, horses, pigs, sheep

For intramuscular use

Portugal

| Vetlima |
| --- |
| Sociedade Distribuidora de Produtos Agro-Pecuários, S.A. |
| Centro Empresarial da Rainha, Lote 27 |
| 2050-501 Vila Nova da Rainha |
| Portugal |

Vetlima

Sociedade Distribuidora de Produtos Agro-Pecuários, S.A.

Centro Empresarial da Rainha, Lote 27

2050-501 Vila Nova da Rainha

Portugal

Vitalbion solução injetável para bovinos, ovinos e suínos

Vitamin A

Vitamin D3

Vitamin E

500 000 IU/ml

75 000 IU/ml

50 mg

Solution for injection

Cattle, pigs, sheep

For intramuscular use

Portugal

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E pro injectione, solução injetável para equídeos, bovinos, suínos e cães

Retinol palmitate

Vitamin D3 Vitamin E acetate

176,47  mg/ml (300 000 IU)

100 mg/ml

50 mg/ml

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Romania

| Interchemie werken ‘De Adelaar’ B.V. |
| --- |
| Metaalweg 8, |
| 5404 CG Venray |
| The Netherlands |

Interchemie werken ‘De Adelaar’ B.V.

Metaalweg 8,

5404 CG Venray

The Netherlands

Introvit

Vitamin A (retinol palmitate) Vitamin D3 (cholecalciferol) VitaminE (α- tocoferol acetate) Vitamin B1 (thiamine HCl) Vitamin B2 (Riboflavin sodium fosfate) Vitamin B6 (Pyridoxine HCl) Vitamin B12 (Cyancobalamin) D-panthenol Nicotinamide Folic acid

Choline chloride

Biotin

D, L — methionine

L- lysine HCl

15 000 IU

7 500 IU

20 mg

10 mg

5 mg

3 mg

60 μg

25 mg

50 mg

150 μg

12,5  mg

125 μg

5 mg

7 mg

Solution for injection

Cattle, horses, goats, sheep, pigs

For intramuscular and subcutaneous use

Romania

| Dutch Farm International BV, |
| --- |
| Nieuw Walden 112, 1394 PE Nederhorst den Berg |
| The Netherlands |

Dutch Farm International BV,

Nieuw Walden 112, 1394 PE Nederhorst den Berg

The Netherlands

Multivit inj.

Vitamin A concentrate

Oily concentrate cholecalciferol (vitamin D3) Tocoferol acetate (vitamin E)

Thiamine HCl (vitamin B1) Riboflavin sodium fosfate (vitamin B2)

Pyridoxine HCl (vitamin B6)

Cyancobalamin (vitamin B12)

Ascorbic acid (vitamin C)

Nicotinamide

D-panthenol

50 000 IU

25 000 IU

4 mg

2,5  mg

2 mg

1,25  mg

30 μg

2 mg

12,5  mg

3 mg

Solution for injection

Horses, foals, cattle, calves, lambs, piglets, sows, chickens, pigeons

For intramuscular and subcutaneous use

Romania

| S.C. Romvac Company S.A. |
| --- |
| Şos. Centurii, nr. 7 |
| Voluntari |
| Romania |

S.C. Romvac Company S.A.

Şos. Centurii, nr. 7

Voluntari

Romania

Multivitarom

Choline,

Vitamin A

Vitamin B1

Vitamin B2

Vitamin B3

Vitamin B5

Vitamin B6

Vitamin C

Vitamin D3

Vitamin E,

Vitamin B12

0,25  mg/ml,

20 000 IU

0,1  mg/ml

0,08  mg/ml

0,35  mg/ml

0,50  mg/ml

0,10  mg/ml

50 mg/ml

200 IU/ml

8 IU /ml

0,50  mg/ml

Solution for injection

Cattle, horses, goats, sheep, pigs, dogs, cats

For intramuscular use

Romania

| S. C. Pasteur — Filiala Filipesti S.A |
| --- |
| str. Principala, |
| nr.Jud |
| Prahova |
| Romania |

S. C. Pasteur — Filiala Filipesti S.A

str. Principala,

nr.Jud

Prahova

Romania

Multi-vita-vet

Vitamin A (retinol palmitate)

Vitamin D3 (cholecalciferol)

Vitamin E (tocoferol acetate)

Vitamin B1 (Thiamine HCl)

Vitamin B2 (Riboflavin sodium phosphate)

Vitamin B3 (Nicotinamide)

Vitamin B6 (Pyridoxine HCl)

Vitamin B12 (Cyancobalamin)

Vitamin B5 (D-panthenol)

1 ml:

15 000 IU

1 100 IU

20 mg

10 mg

7 mg

35 mg

3,5  mg

0,005  mg

25 mg

Solution for injection

Cattle, horses, sheep, goats, pigs, dogs, cats

For intramuscular and subcutaneous use

Romania

| Kepro B.V. |
| --- |
| Maagdenburgstraat 17 |
| 7421 ZA Deventer |
| The Netherlands |

Kepro B.V.

Maagdenburgstraat 17

7421 ZA Deventer

The Netherlands

Vitaflash

Vitamin A (retinol palmitate)

Vitamin B1 HCl (thiamine HCl)

Vitamin B2 (riboflavin sodium phosphate)

Vitamin B3 (nicotinamide)

Vitamin B6 (pyridoxine HCl)

Vitamin C (ascorbic acid)

Vitamin D3 (cholecalciferol)

Vitamin E acetate (α-tocoferol acetate)

Vitamin B12 (Cyancobalamine)

Vitamin B5 (D-panthenol)

1 ml:

50 000 IU

2,5  mg

2 mg

12,5  mg

1,25  mg

2 mg

25 000 IU

4 mg

30 μg

3 mg

Solution for injection

Cattle, horses, sheep, pigs

For intramuscular and subcutaneous use

Romania

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vitamin AD3E

Vitamin A

Vitamin D3

Vitamin E

176,47  mg (300 000 IU)

2,50  mg (100 000  IU)

50 mg

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Romania

| S.C. Romvac Company S.A. |
| --- |
| Şos. Centurii, nr. 7 |
| Voluntari |
| Romania |

S.C. Romvac Company S.A.

Şos. Centurii, nr. 7

Voluntari

Romania

Vitamin AD3E

Vitamin A

Vitamin D3

Vitamin E

50 000 IU/ml,

5 000 IU/ml,

20 mg/ml

Solution for injection

Cattle, horses, sheep, goats, pigs, poultry, dogs, cats, pigeons

For intramuscular and subcutaneous use

Romania

| S. C. Pasteur — Filiala Filipesti S.A |
| --- |
| str. Principala, |
| nr. Jud |
| Prahova |
| Romania |

S. C. Pasteur — Filiala Filipesti S.A

str. Principala,

nr. Jud

Prahova

Romania

Vitamina AD3E

Vitamin A (as palmitate)

Vitamin D3 (cholecalciferol) Vitamin E (as α-tocopherol acetate)

100 000 IU/ml

10 000  IU/ml

50 IU/ml

Solution for injection

Cattle, horses, goats, rabbits, sheep, pigs, dogs, cats

For intramuscular and subcutaneous use

Romania

| Interchemie Werken De Adelaar Eesti AS |
| --- |
| Vanapere tee 14, Püünsi küla |
| Viimsi vald, Harju maakond |
| 74013 |
| Estonia |

Interchemie Werken De Adelaar Eesti AS

Vanapere tee 14, Püünsi küla

Viimsi vald, Harju maakond

74013

Estonia

Vitol-140

Vitamin A (retinol palmitate)

Vitamin D3 (cholecalciferol)

Vitamin E (α-tocopherol acetate)

80 000 IU/ml

40 000  IU/ml

20 mg/ml

Solution for injection

Cattle, horses, sheep, goats, pigs, dogs, cats

For intramuscular and subcutaneous use

Romania

| Alapis S.A. |
| --- |
| 19 300 Aspropyrgos |
| Mailbox 26 |
| Athens |
| Greece |

Alapis S.A.

19 300 Aspropyrgos

Mailbox 26

Athens

Greece

Zingul AD3E

Vitamin A

Vitamin D3 Vitamin E

50 000 IU/ml

25 000 IU/ml

50 mg/ml

Solution for injection

Cattle, horses, goats, sheep, pigs

For intramuscular use

Slovakia

| Bioveta, a. s. |
| --- |
| Komenského 212 |
| 683 23 Ivanovice na Hané |
| Czech Republic |

Bioveta, a. s.

Komenského 212

683 23 Ivanovice na Hané

Czech Republic

ADE-vit Injekčný roztok

Retinoli propionas-Ergocalciferolum Tocoferoli alfa acetas

1 ml:

100 000 IU

100 000 IU

30 mg

Solution for injection

Cattle, dogs, goats, horses, pigs, rabbits, sheep

For intramuscular use

Slovakia

| Pharmagal Ltd. |
| --- |
| Murgašova 5, |
| 949 01 Nitra |
| Slovak Republic |

Pharmagal Ltd.

Murgašova 5,

949 01 Nitra

Slovak Republic

Triavit injekčný roztok

Retinoli palmitas

Colecalciferolum

Tocoferoli alfa acetas

1 ml:

100 000 IU

50 000 IU

50 mg

Solution for injection

Cattle, horses, calves, pigs, foals, lambs, piglets, dogs, rabbits, poultry

For intramuscular and subcutaneous use

Slovakia

| Richter Pharma AG |
| --- |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Vitasol AD3EC injekčný roztok

Retinoli palmitas

Colecalciferolum

Tocoferoli alfa acetas

Acidum ascorbicum

1 ml:

50 000 IU

25 000 IU

30 mg

100 mg

Solution for injection

Horses, cattle, pigs, dogs

For intramuscular and subcutaneous use

Slovenia

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Belavit AD3E, raztopina za injiciranje za konje, govedo, prašiče in pse

Retinol palmitate (vitamin A) Vitamin D3 Vitamin E acetate

176,47  mg (300 000 IU)

100 mg per ml

50 mg per ml

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Slovenia

| Krka, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6 |
| 8501 Novo mesto |
| Slovenia |

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Vitamin AD3E Krka emulzija za injiciranje za govedo, konje, prašiče, ovce, koze, kunce, pse in mačke

Vitamin A

Cholecalciferol

Tocopheryl acetate (vitamin E)

50 000 IU/ml

25 000 IU/ml

20 mg/ml

Emulsion for injection

Cattle, horses, pigs, sheep, goats, dogs, cats, rabbits

For intramuscular and subcutaneous use

Spain

| S.P Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km 4.1, |
| Riudoms (Tarragona) |
| Spain |

S.P Veterinaria, S.A.

Ctra. Reus-Vinyols, km 4.1,

Riudoms (Tarragona)

Spain

ADEX-3-emulsion inyectable

Vitamin A (retinyl palmitate)

Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

50 000 IU

25 000 IU

20 mg

Emulsion for injection

Cattle, goats, horses (foals), pigs, sheep

For intramuscular use

Spain

| S.P Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, km 4.1, |
| Riudoms (Tarragona) |
| Spain |

S.P Veterinaria, S.A.

Ctra. Reus-Vinyols, km 4.1,

Riudoms (Tarragona)

Spain

ADEX-3-Forte

Vitamin A (retinyl propionate)

Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

500 000 IU

75 000 UI

50 mg

Solution for injection

Cattle, goats, pigs, sheep

For intramuscular and subcutaneous use

Spain

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Belavit AD3

Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

176,47  mg

100 mg

50 mg

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

Spain

Laboratorios Ovejero, S.A., Ctra. Leon-Vilecha No. 30, 24192 Leon, Spain

Biosvita AD3E parenteral emulsion inyectable

Vitamin A (retinyl palmitate)

All-rac-α-tocopheryl acetate (vitamin E)

Cholecalciferol (vitamin D3)

75 000 IU

15 000 UI

30 mg

Emulsion for injection

Cattle, sheep, goats, pigs, horses

For intramuscular use

Spain

| Laboratorios Hipra, |
| --- |
| S.A. Avda. La Selva, 135 |
| Amer — Gerona |
| 17170 |
| Spain |

Laboratorios Hipra,

S.A. Avda. La Selva, 135

Amer — Gerona

17170

Spain

Hipravit-AD3E Forte

Vitamin A (retinyl palmitate)

Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

500 000 IU

75 000 UI

50 mg

Solution for injection

Cattle, pigs, sheep, horses, rabbits

For intramuscular use

Spain

| Labiana Life Sciences S.A. |
| --- |
| Venus, 26 |
| Terrassa |
| 08228 Barcelona |
| Spain |

Labiana Life Sciences S.A.

Venus, 26

Terrassa

08228 Barcelona

Spain

Labhidro AD3E Solucion inyectable

Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

500 000 IU

75 000 UI

50 mg

Solution for injection

Cattle, horses, pigs, sheep

For intramuscular use

Spain

| Labiana Life Sciences S.A. |
| --- |
| Venus, 26 |
| Terrassa |
| 08228 Barcelona |
| Spain |

Labiana Life Sciences S.A.

Venus, 26

Terrassa

08228 Barcelona

Spain

NOV-A-VIT emulsion inyectable

Vitamin A (retinyl propionate) Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

500 000 IU

75 000 IU

50 mg

Emulsion for injection

Cattle, goats, pigs, sheep

For intramuscular use

Spain

| Divasa-Farmavic, S.A. |
| --- |
| Ctra. Sant Hipòlit, km 71 |
| 08503 GURB — VIC |
| Barcelona |
| Spain |

Divasa-Farmavic, S.A.

Ctra. Sant Hipòlit, km 71

08503 GURB — VIC

Barcelona

Spain

Polivit AD3E solucion inyectable

Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

500 000 IU

75 000 IU

50 IU

Solution for injection

Cattle, sheep, pigs

For intramuscular use

Spain

| Laboratorios Ovejero, S.A., |
| --- |
| Ctra. Leon-Vilecha 30, 24192 Leon, |
| Spain |

Laboratorios Ovejero, S.A.,

Ctra. Leon-Vilecha 30, 24192 Leon,

Spain

Polyfil

Phosphorylcholine, retinol, vitamin B12, vitamin E

80 g

5 000 IU

0,05  mg

20 g

Emulsion for injection

Cattle, horses, pigs

For intramuscular use

Spain

| Fatro Iberica, S.L. Constitucion, 1 — Planta baja, 3 Sant Just Desvern (Barcelona) 08960 |
| --- |
| Spain |

Fatro Iberica, S.L. Constitucion, 1 — Planta baja, 3 Sant Just Desvern (Barcelona) 08960

Spain

Vetidina AD3E

Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

500 000 IU

75 000 UI

50 mg

Solution for injection

Cattle, pigs, sheep

For intramuscular use

Spain

| Cenavisa, S.L. |
| --- |
| Cami Pedra Estela s/n |
| Reus (Tarragona) |
| 43205 |
| Spain |

Cenavisa, S.L.

Cami Pedra Estela s/n

Reus (Tarragona)

43205

Spain

Vitacen AD3E

Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

500 000 IU

75 000 UI

50 mg

Solution for injection

Cattle, sheep, goats, pigs, horses

For intramuscular use

Spain

| Chemical Iberica Productos Veterinarios, S.L., CR. Burgos-Portugal, Km. 256, Calzada de Don Diego (Salamanca), 37448, |
| --- |
| Spain |

Chemical Iberica Productos Veterinarios, S.L., CR. Burgos-Portugal, Km. 256, Calzada de Don Diego (Salamanca), 37448,

Spain

Vitachemical ADE Masivo

Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

30 000 UI

10 000 UI

12,5  mg

Solution for injection

Cattle, pigs, sheep, goats, horses

For intramuscular use

Spain

| Industrial Veterinaria, s.a. |
| --- |
| C/ Esmeralda 19 |
| Esplugues de Llobregat |
| 08950 Barcelona |
| Spain |

Industrial Veterinaria, s.a.

C/ Esmeralda 19

Esplugues de Llobregat

08950 Barcelona

Spain

Vitamina AD3E Solucion inyectable

Vitamin A (retinyl palmitate)

Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

500 000 IU

75 000 IU

50 mg

Solution for injection

Cattle, sheep, goats, pigs

For intramuscular use

Spain

| Super's Diana, S.L. |
| --- |
| Ctra. C-17, km 17 |
| 08150 Parets del Vallès |
| Barcelona |
| Spain |

Super's Diana, S.L.

Ctra. C-17, km 17

08150 Parets del Vallès

Barcelona

Spain

Vitaminas ADE Super's Diana solución inyectable

Vitamin A (retinyl palmitate)

Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

100 000 IU

50 000 IU

50 mg

Solution for injection

Cattle, pigs, sheep, horses, poultry (broilers, duck broilers, turkeys for meat production), dogs

For intramuscular use

Spain

| Laboratorios e Industrias Iven, S.A. |
| --- |
| Luís I, 56 |
| 28031 Madrid |
| Spain |

Laboratorios e Industrias Iven, S.A.

Luís I, 56

28031 Madrid

Spain

Vitamiven A-D-E Solución inyectable

Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

300 000 IU

100 000 IU

50 mg

Solution for injection

Cattle, sheep, goats, horses, pigs

For intramuscular use

Spain

| Laboratorios e Industrias Iven, S.A. |
| --- |
| Luís I, 56 |
| 28031 Madrid |
| Spain |

Laboratorios e Industrias Iven, S.A.

Luís I, 56

28031 Madrid

Spain

Vitamiven complejo solucion inyectable

Vitamin A (retinyl palmitate)

Cholecalciferol (vitamin D3)

All-rac-α-tocopheryl acetate (vitamin E)

thiamine hydrochloride (vitamin B1)

Riboflavin sodium phosphate (vitamin B2)

Nicotinamide (vitamin B3)

Dexpanthenol (vitamin B5)

Pyridoxine hydrochloride (vitamin B6)

Cyanocobalamin (vitamin B12)

30 000 IU

10 000 IU

5 mg

25 mg

4 mg

50 mg

25 mg

20 mg

0,05  mg

Solution for injection

Cattle, sheep, goats, horses, pigs, dogs, cats

For intramuscular use

Sweden

| Pharmaxim AB |
| --- |
| Stenbrovägen 32 |
| 253 68 Helsingborg |
| Sweden |

Pharmaxim AB

Stenbrovägen 32

253 68 Helsingborg

Sweden

Ultrasan vet

RRR-alpha-tocopheryl acetate, ergocalciferol, retinol palmitate

1 ml:

100 mg,

50 000 IU,

100 000  IU

Solution for injection

Horses, cattle, sheep, dogs, pigs

For intramuscular use

The Netherlands

| Kombivet B.V. |
| --- |
| Raadhuisstraat 124 Hoogerheide |
| The Netherlands |

Kombivet B.V.

Raadhuisstraat 124 Hoogerheide

The Netherlands

Adedri-Kel (100 + 50 + 5)

Vitamine A

Cholecalciferol

Alfa-tocopherolacetate

100 000 IU

50 000 IU

5 mg

Solution for injection

Cattle, horses, pigs, sheep, goats

For intramuscular use

The Netherlands

| Aesculaap Groothandel B.V. |
| --- |
| Mijlstraat 35 Boxtel |
| 5281 LJ |
| The Netherlands |

Aesculaap Groothandel B.V.

Mijlstraat 35 Boxtel

5281 LJ

The Netherlands

Aescavit

Cholecalciferol

Cyanocobalamin

sodiumpantothenate

Nicotinamid

Retinolacetate

Riboflavin Sodiumphosphate Anhydrate

Thiaminehydrochlorid

Tocoferol, DL-alfa acetate

25 000 IU/ml

20 μg/ml

2,8  mg/ml

10 mg/ml

25 000 IU/ml

0,7  mg/ml

10 mg/ml

5 mg/ml

Solution for injection

Horses, foals, cattle, pigs, piglets, sheep, lambs, cats, minks

For intramuscular and subcutaneous use

The Netherlands

| Alfasan Nederland B.V. |
| --- |
| Kuipersweg 9 Woerden |
| 3449 JA |
| The Netherlands |

Alfasan Nederland B.V.

Kuipersweg 9 Woerden

3449 JA

The Netherlands

Multivitamin Pro inj.

Vitamin A

Cholecalciferole

Alfa-tocoferolacetate

Thiaminhydrochlorid

Riboflavin sodiumphosphate

Pyridoxin hydrochlorid

Cyanocobalamin

Nicotinamid

D-panthenole

15 000 IU

1 000 IU

20 mg

10 mg

6,85  mg

3 mg

50 μg

35 mg

25 mg

Solution for injection

Cattle, lambs, pigs, piglets

For intramuscular use

The Netherlands

| Alfasan Nederland B.V. |
| --- |
| Kuipersweg 9 Woerden |
| 3449 JA |
| The Netherlands |

Alfasan Nederland B.V.

Kuipersweg 9 Woerden

3449 JA

The Netherlands

Vitamine AD3 80/40 Pro inj.

Vitamin A

Cholecaliferole

Alfa-tocoferolacetate

80 000 IU

40 000 IU

10 mg

Solution for injection

Cattle, calves, horses, foals, sheep, goats, pigs, piglets, dogs, cats

For intramuscular and subcutaneous use

The Netherlands

| Alfasan Nederland B.V. |
| --- |
| Kuipersweg 9 Woerden |
| 3449 JA |
| The Netherlands |

Alfasan Nederland B.V.

Kuipersweg 9 Woerden

3449 JA

The Netherlands

Vitamine AD3 80/40, oplossing voor injectie

Vitamin A

Cholecaliferole

Alfa-tocooferolacetate

80 000 IU

40 000 IU

10 mg

Solution for injection

Cattle, calves, horses, foals, sheep, goats, pigs, piglets

For intramuscular and subcutaneous use

The Netherlands

| Alfasan Nederland B.V. |
| --- |
| Kuipersweg 9 Woerden |
| 3449 JA |
| The Netherlands |

Alfasan Nederland B.V.

Kuipersweg 9 Woerden

3449 JA

The Netherlands

Vitamine AD3E 450.000 Pro inj.

Vitamin A

Cholecaliferole

Alfa-tocooferolacetate

300 000 IU

100 000 IU

50 mg

Solution for injection

Cattle, calves, horses, foals, pigs, piglets, sheep, goats

For intramuscular and subcutaneous use

United Kingdom (Northern Ireland) (1)

| Bela-pharm GmbH & Co. KG |
| --- |
| Lohner Str. 19 |
| 49377 Vechta |
| Germany |

Bela-pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Belavit AD3E, Solution for Injection for horses, cattle, pigs, and dogs

Retinol palmitate

All-rac alpha tocopheryl acetate

Oily solution of cholecalciferol

176,47  mg

50 mg

100 mg

Solution for injection

Cattle, pigs, horses, dogs

For intramuscular and subcutaneous use

---

(1)  For the United Kingdom, as from 1 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

ANNEX IIB

List of authorised veterinary medicinal products recommended for suspension of the marketing authorisation

| Member State EU/EEA | Marketing authorisation holders | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| France | Ceva Santé Animale |
| 10 Av. de le Ballestiere |
| 33500 Libourne |
| France |

Member State EU/EEA

Marketing authorisation holders

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

France

Ceva Santé Animale

10 Av. de le Ballestiere

33500 Libourne

France

Multivit 500

Retinol (as propionate),

Cholecalciferol,

Alpha-tocopherol (as acetate)

500 000 IU per ml

75 000 IU per ml

50 mg per ml

Solution for injection

Cattle, sheep, pigs

For subcutaneous use

---