# C_2023076EN.01000501.xml

| 28.2.2023 | EN | Official Journal of the European Union | C 76/5 |
| --- | --- | --- | --- |

28.2.2023

EN

Official Journal of the European Union

C 76/5

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2023 to 31 January 2023

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))

(2023/C 76/02)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2023 | JCOVDEN | COVID-19 vaccine (Ad26.COV2-S [recombinant]) | Janssen-Cilag International NV |
| Turnhoutseweg 30, 2340 Beerse, België |

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

9.1.2023

JCOVDEN

COVID-19 vaccine (Ad26.COV2-S [recombinant])

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

Suspension for injection

J07BX03

9.1.2023

10.1.2023

Pirfenidone Viatris

pirfenidone

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

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/22/1707

Film-coated tablet

L04AX05

11.1.2023

10.1.2023

Sugammadex Amomed

sugammadex

| AOP Orphan Pharmaceuticals GmbH, |
| --- |
| Leopold-Ungar-Platz 2, 1190 Wien, Österreich |

AOP Orphan Pharmaceuticals GmbH,

Leopold-Ungar-Platz 2, 1190 Wien, Österreich

EU/1/22/1708

Solution for injection

V03AB35

11.1.2023

12.1.2023

Kauliv

teriparatide

| Strides Pharma (Cyprus) Ltd. |
| --- |
| Themistokli Dervi, 3, Julia House, 1st Floor, 1066, Nicosia, Κύπρος |

Strides Pharma (Cyprus) Ltd.

Themistokli Dervi, 3, Julia House, 1st Floor, 1066, Nicosia, Κύπρος

EU/1/22/1710

Solution for injection

H05AA02

7.2.2023

—   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 |
| --- | --- | --- | --- | --- |
| 5.1.2023 | JCOVDEN | Janssen-Cilag International NV |
| Turnhoutseweg 30, 2340 Beerse, België |

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

5.1.2023

JCOVDEN

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

6.1.2023

5.1.2023

Nuvaxovid

| Novavax CZ, a.s. |
| --- |
| Bohumil 138, 281 63 Jevany, Česká republika |

Novavax CZ, a.s.

Bohumil 138, 281 63 Jevany, Česká republika

EU/1/21/1618

6.1.2023

5.1.2023

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

6.1.2023

9.1.2023

Busilvex

| PIERRE FABRE MEDICAMENT |
| --- |
| Les Cauquillous, 81500 Lavaur, France |

PIERRE FABRE MEDICAMENT

Les Cauquillous, 81500 Lavaur, France

EU/1/03/254

11.1.2023

9.1.2023

ellaOne

| Laboratoire HRA Pharma |
| --- |
| 200 avenue de Paris, 92320 Chatillon, France |

Laboratoire HRA Pharma

200 avenue de Paris, 92320 Chatillon, France

EU/1/09/522

11.1.2023

9.1.2023

Mirapexin

| 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/1/97/051

11.1.2023

9.1.2023

Prasugrel Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/18/1273

11.1.2023

9.1.2023

Xevudy

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1562

11.1.2023

10.1.2023

Alofisel

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbaek Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/17/1261

19.1.2023

10.1.2023

Biktarvy

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/18/1289

11.1.2023

10.1.2023

Darzalex

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

11.1.2023

10.1.2023

Fulvestrant Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1253

11.1.2023

10.1.2023

Hemangiol

| PIERRE FABRE MEDICAMENT |
| --- |
| Les Cauquillous, 81500 Lavaur, France |

PIERRE FABRE MEDICAMENT

Les Cauquillous, 81500 Lavaur, France

EU/1/14/919

17.1.2023

10.1.2023

JEVTANA

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/11/676

12.1.2023

10.1.2023

Lokelma

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

12.1.2023

10.1.2023

Lyxumia

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/12/811

17.1.2023

10.1.2023

Palonosetron 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/1/16/1104

11.1.2023

10.1.2023

Skyrizi

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1361

11.1.2023

10.1.2023

Spherox

| Rejuvenate GmbH |
| --- |
| Deutscher Platz 5d, 04103 Leipzig, Deutschland |

Rejuvenate GmbH

Deutscher Platz 5d, 04103 Leipzig, Deutschland

EU/1/17/1181

11.1.2023

10.1.2023

Velphoro

| Vifor Fresenius Medical Care Renal Pharma France |
| --- |
| 100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France |

Vifor Fresenius Medical Care Renal Pharma France

100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

EU/1/14/943

11.1.2023

10.1.2023

Vocabria

| 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/1/20/1481

11.1.2023

10.1.2023

Xofluza

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

Roche Registration GmbH

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

EU/1/20/1500

11.1.2023

12.1.2023

Caprelsa

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

13.1.2023

12.1.2023

Dimethyl fumarate Neuraxpharm

| Laboratorios Lesvi, S.L. |
| --- |
| Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España |

Laboratorios Lesvi, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España

EU/1/22/1637

7.12.2022

12.1.2023

Dimethyl fumarate Neuraxpharm

| Laboratorios Lesvi, S.L. |
| --- |
| Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España |

Laboratorios Lesvi, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí — Barcelona, España

EU/1/22/1637

17.1.2023

12.1.2023

Juluca

| ViiV Healthcare B.V. |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands |

ViiV Healthcare B.V.

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

EU/1/18/1282

13.1.2023

12.1.2023

Lopinavir/Ritonavir Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/15/1067

13.1.2023

12.1.2023

Mayzent

| 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/1/19/1414

13.1.2023

12.1.2023

Ogivri

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

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1341

13.1.2023

12.1.2023

Pregabalin Zentiva

| Zentiva, k.s. |
| --- |
| U Kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

13.1.2023

12.1.2023

Pregabalin Zentiva k.s

| Zentiva, k.s. |
| --- |
| U Kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1166

13.1.2023

12.1.2023

Twinrix Adult

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/96/020

17.1.2023

12.1.2023

Twinrix Paediatric

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/97/029

17.1.2023

13.1.2023

Holoclar

| Holostem Terapie Avanzate S.r.l. |
| --- |
| Via Glauco Gottardi 100, Modena, MO 41125, Italia |

Holostem Terapie Avanzate S.r.l.

Via Glauco Gottardi 100, Modena, MO 41125, Italia

EU/1/14/987

16.1.2023

13.1.2023

Klisyri

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, 08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/21/1558

16.1.2023

13.1.2023

Lamzede

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1258

16.1.2023

13.1.2023

Lojuxta

| Amryt Pharmaceuticals DAC |
| --- |
| 45 Mespil Road, Dublin 4, Ireland |

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/13/851

18.1.2023

13.1.2023

Miglustat Dipharma

| Dipharma Arzneimittel GmbH |
| --- |
| Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland |

Dipharma Arzneimittel GmbH

Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland

EU/1/18/1346

18.1.2023

13.1.2023

Rotarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/05/330

18.1.2023

23.1.2023

Dupixent

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

24.1.2023

23.1.2023

Edistride

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

24.1.2023

23.1.2023

Efavirenz Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/742

24.1.2023

23.1.2023

Enhertu

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

24.1.2023

23.1.2023

Ferriprox

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/99/108

24.1.2023

23.1.2023

Fintepla

| Zogenix ROI Limited |
| --- |
| Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland |

Zogenix ROI Limited

Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland

EU/1/20/1491

24.1.2023

23.1.2023

Glyxambi

| 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/1/16/1146

25.1.2023

23.1.2023

Hemlibra

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

Roche Registration GmbH

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

EU/1/18/1271

25.1.2023

23.1.2023

Mirvaso

| Galderma International |
| --- |
| Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France |

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

24.1.2023

23.1.2023

NULOJIX

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/11/694

29.1.2023

23.1.2023

Pioglitazone 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/1/11/722

24.1.2023

23.1.2023

Qarziba

| EUSA Pharma (Netherlands) B.V. |
| --- |
| Beechavenue 54, 1119PW Schiphol-Rijk, Nederland |

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1191

26.1.2023

23.1.2023

Reagila

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

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/17/1209

26.1.2023

23.1.2023

Remicade

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, 2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116

24.1.2023

23.1.2023

Reyataz

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/03/267

29.1.2023

23.1.2023

RoActemra

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

Roche Registration GmbH

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

EU/1/08/492

24.1.2023

23.1.2023

Stalevo

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/03/260

1.2.2023

23.1.2023

Sunitinib 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/1/20/1511

25.1.2023

23.1.2023

Synjardy

| 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/1/15/1003

25.1.2023

24.1.2023

Fintepla

| Zogenix ROI Limited |
| --- |
| Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland |

Zogenix ROI Limited

Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland

EU/1/20/1491

31.1.2023

30.1.2023

Aprovel

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/97/046

2.2.2023

30.1.2023

Baraclude

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/06/343

31.1.2023

30.1.2023

CoAprovel

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/086

2.2.2023

30.1.2023

Comirnaty

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2.2.2023

30.1.2023

Imfinzi

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

31.1.2023

30.1.2023

Lenalidomide 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/1/18/1316

2.2.2023

30.1.2023

Memantine 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/1/13/880

1.2.2023

30.1.2023

Repatha

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

1.2.2023

30.1.2023

Sapropterin Dipharma

| Dipharma Arzneimittel GmbH |
| --- |
| Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland |

Dipharma Arzneimittel GmbH

Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland

EU/1/21/1620

31.1.2023

30.1.2023

Sapropterin Dipharma

| Dipharma Arzneimittel GmbH |
| --- |
| Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland |

Dipharma Arzneimittel GmbH

Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland

EU/1/21/1620

8.2.2023

30.1.2023

Tyverb

| 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/1/07/440

31.1.2023

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

—

Withdrawal of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 9.1.2023 | Busilvex | PIERRE FABRE MEDICAMENT |
| Les Cauquillous, 81500 Lavaur, France |

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

9.1.2023

Busilvex

PIERRE FABRE MEDICAMENT

Les Cauquillous, 81500 Lavaur, France

EU/1/03/254

11.1.2023

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 26.1.2023 | Brucellin Aquilon | Brucella abortus, strain AQ1302, protein extract | Aquilón CyL S.L. |
| Facultad de Veterinaria, Campus de Vegazana s/n, 24007 León, España |

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

26.1.2023

Brucellin Aquilon

Brucella abortus, strain AQ1302, protein extract

Aquilón CyL S.L.

Facultad de Veterinaria, Campus de Vegazana s/n, 24007 León, España

EU/2/22/291

Solution for injection

QI09AR

30.1.2023

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 |
| --- | --- | --- | --- | --- |
| 9.1.2023 | GALLIPRANT | Elanco GmbH |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

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

9.1.2023

GALLIPRANT

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/221

10.1.2023

9.1.2023

Metacam

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

12.1.2023

9.1.2023

Novaquin

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

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/15/186

12.1.2023

9.1.2023

Oxybee

| Dany Bienenwohl GmbH |
| --- |
| Geyerspergerstraße 27, 80689 München, Deutschland |

Dany Bienenwohl GmbH

Geyerspergerstraße 27, 80689 München, Deutschland

EU/2/17/216

12.1.2023

9.1.2023

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

10.1.2023

9.1.2023

Semintra

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/146

12.1.2023

9.1.2023

Vectra 3D

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/13/156

10.1.2023

9.1.2023

Versican Plus Pi/L4R

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

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

EU/2/14/173

12.1.2023

24.1.2023

BLUEVAC BTV

| CZ Veterinaria, S.A. |
| --- |
| La Relva s/n — Torneiros, 36410 Porriño, España |

CZ Veterinaria, S.A.

La Relva s/n — Torneiros, 36410 Porriño, España

EU/2/11/122

25.1.2023

24.1.2023

BTVPUR

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/10/113

27.1.2023

24.1.2023

Credelio Plus

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/21/271

25.1.2023

24.1.2023

ERYSENG PARVO

| 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/2/14/167

27.1.2023

24.1.2023

Eurican Herpes 205

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/01/029

26.1.2023

24.1.2023

Fevaxyn Pentofel

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium SA

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

EU/2/96/002

27.1.2023

24.1.2023

Improvac

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium SA

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

EU/2/09/095

25.1.2023

24.1.2023

Mirataz

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25, 5531 AE Bladel, Nederland |

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/19/247

27.1.2023

24.1.2023

Panacur AquaSol

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/135

25.1.2023

24.1.2023

Porcilis PCV ID

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/187

26.1.2023

24.1.2023

Prevomax

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25, 5531 AE Bladel, Nederland |

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/17/211

30.1.2023

24.1.2023

Purevax RC

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/051

27.1.2023

24.1.2023

Purevax RCP

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/052

27.1.2023

24.1.2023

Purevax RCPCh FeLV

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/047

27.1.2023

26.1.2023

Imoxat

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Loughrea, Co. Galway, Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/21/280

27.1.2023

26.1.2023

Meloxidolor

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

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/13/148

31.1.2023

26.1.2023

NexGard

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/13/159

27.1.2023

26.1.2023

NEXGARD SPECTRA

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/14/177

27.1.2023

26.1.2023

Purevax RCPCh

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/050

27.1.2023

26.1.2023

Purevax RCP FeLV

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/048

27.1.2023

26.1.2023

Solensia

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium SA

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

EU/2/20/269

27.1.2023

26.1.2023

Suvaxyn CSF Marker

| Zoetis Belgium |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium

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

EU/2/14/179

30.1.2023

26.1.2023

Suvaxyn PRRS MLV

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium SA

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

EU/2/17/215

27.1.2023

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

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

(2)  OJ L 4, 7.1.2019, p. 43.

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