# C_2022289EN.01000101.xml

| 29.7.2022 | EN | Official Journal of the European Union | C 289/1 |
| --- | --- | --- | --- |

29.7.2022

EN

Official Journal of the European Union

C 289/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2022 to 30 June 2022

(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))

(2022/C 289/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.6.2022 | Lunsumio | mosunetuzumab | Roche Registration GmbH |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

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

3.6.2022

Lunsumio

mosunetuzumab

Roche Registration GmbH

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

EU/1/22/1649

Concentrate for solution for infusion

L01XC

7.6.2022

14.6.2022

Yselty

linzagolix choline

| ObsEva Ireland Ltd. |
| --- |
| Penthouse Floor, 5 Lapps Quay, Cork, T12 RW7D, Ireland |

ObsEva Ireland Ltd.

Penthouse Floor, 5 Lapps Quay, Cork, T12 RW7D, Ireland

EU/1/21/1606

Film-coated tablet

Pending

17.6.2022

20.6.2022

Pirfenidone AET

pirfenidone

| Alfred E. Tiefenbacher (GmbH & Co. KG) |
| --- |
| Van der Smissen Strasse 1, 22767 Hamburg, Deutschland |

Alfred E. Tiefenbacher (GmbH & Co. KG)

Van der Smissen Strasse 1, 22767 Hamburg, Deutschland

EU/1/22/1655

Film-coated tablet

L04AX05

27.6.2022

20.6.2022

Tabrecta

capmatinib

| 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/1/22/1650

Film-coated tablet

L01EX17

21.6.2022

21.6.2022

Filsuvez

birch bark extract

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

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/22/1652

Gel

D03AX13

23.6.2022

24.6.2022

Nexviadyme

avalglucosidase alfa

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1579

Powder for concentrate for solution for infusion

Pending

27.6.2022

24.6.2022

Xenpozyme

olipudase alfa

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/22/1659

Powder for concentrate for solution for infusion

A16AB25

27.6.2022

—   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 |
| --- | --- | --- | --- | --- |
| 2.6.2022 | Abraxane | Bristol-Myers Squibb Pharma EEIG |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

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

2.6.2022

Abraxane

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/428

8.6.2022

2.6.2022

Anoro Ellipta

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

5.6.2022

2.6.2022

Comtan

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/98/081

3.6.2022

2.6.2022

Cufence

| Univar Solutions B.V. |
| --- |
| Schouwburgplein 30, Rotterdam, 3012 CL, Nederland |

Univar Solutions B.V.

Schouwburgplein 30, Rotterdam, 3012 CL, Nederland

EU/1/19/1365

7.6.2022

2.6.2022

Exviera

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

3.6.2022

2.6.2022

HALAVEN

| Eisai GmbH |
| --- |
| Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland |

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/11/678

3.6.2022

2.6.2022

Imcivree

| Rhythm Pharmaceuticals Netherlands B.V. |
| --- |
| Radarweg 29, 1043 NX Amsterdam, Nederland |

Rhythm Pharmaceuticals Netherlands B.V.

Radarweg 29, 1043 NX Amsterdam, Nederland

EU/1/21/1564

7.6.2022

2.6.2022

Instanyl

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/09/531

14.6.2022

2.6.2022

Ketoconazole HRA

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

HRA Pharma Rare Diseases

200 avenue de Paris, 92320 Chatillon, France

EU/1/14/965

14.6.2022

2.6.2022

Kigabeq

| ORPHELIA Pharma SAS |
| --- |
| 85 boulevard Saint-Michel, 75005 Paris, France |

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/18/1302

10.6.2022

2.6.2022

Posaconazole 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/1/19/1379

7.6.2022

2.6.2022

Slenyto

| RAD Neurim Pharmaceuticals EEC SARL |
| --- |
| 4 rue de Marivaux, 75002 Paris, France |

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/18/1318

7.6.2022

2.6.2022

Sugammadex 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/1/21/1583

21.6.2022

2.6.2022

Trulicity

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

7.6.2022

2.6.2022

TUKYSA

| Seagen B.V. |
| --- |
| Evert van de Beekstraat 1-104, 1118CL Schiphol, Nederland |

Seagen B.V.

Evert van de Beekstraat 1-104, 1118CL Schiphol, Nederland

EU/1/20/1526

7.6.2022

2.6.2022

Viekirax

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

3.6.2022

2.6.2022

Vyxeos liposomal

| Jazz Pharmaceuticals Ireland Ltd |
| --- |
| 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland |

Jazz Pharmaceuticals Ireland Ltd

5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland

EU/1/18/1308

7.6.2022

2.6.2022

Zepatier

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1119

14.6.2022

7.6.2022

Benlysta

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/11/700

13.6.2022

7.6.2022

Constella

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/12/801

13.6.2022

7.6.2022

CONTROLOC Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/515

9.6.2022

7.6.2022

Ifirmacombi

| 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/1/11/673

9.6.2022

7.6.2022

Ilaris

| 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/1/09/564

8.6.2022

7.6.2022

Irbesartan HCT 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/1/06/377

9.6.2022

7.6.2022

Mozobil

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/09/537

8.6.2022

7.6.2022

Ondexxya

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1345

20.6.2022

7.6.2022

PANTOZOL Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/517

9.6.2022

7.6.2022

Perjeta

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

Roche Registration GmbH

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

EU/1/13/813

8.6.2022

7.6.2022

Rebetol

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/107

14.6.2022

7.6.2022

Rivastigmine Actavis

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/693

8.6.2022

7.6.2022

SOMAC Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/516

9.6.2022

7.6.2022

Stayveer

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/832

8.6.2022

7.6.2022

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

8.6.2022

7.6.2022

Truvada

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

8.6.2022

7.6.2022

VELCADE

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/04/274

8.6.2022

7.6.2022

Xeplion

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/672

8.6.2022

13.6.2022

Afinitor

| 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/1/09/538

15.6.2022

13.6.2022

Aimovig

| 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/1/18/1293

14.6.2022

13.6.2022

Descovy

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1099

14.6.2022

13.6.2022

Enurev Breezhaler

| 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/1/12/789

14.6.2022

13.6.2022

Feraccru

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

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/15/1075

21.6.2022

13.6.2022

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

14.6.2022

13.6.2022

Imfinzi

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

15.6.2022

13.6.2022

Leqvio

| 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/1/20/1494

15.6.2022

13.6.2022

Nyvepria

| 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/1/20/1486

14.6.2022

13.6.2022

Ozurdex

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/10/638

14.6.2022

13.6.2022

Pelgraz

| 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/1/18/1313

15.6.2022

13.6.2022

Pregabalin 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/1/15/1027

15.6.2022

13.6.2022

Xydalba

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/986

14.6.2022

14.6.2022

Lacosamide UCB

| 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/1/19/1383

20.6.2022

14.6.2022

Odefsey

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1112

15.6.2022

14.6.2022

Xermelo

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

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/17/1224

29.6.2022

20.6.2022

Cosentyx

| 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/1/14/980

21.6.2022

20.6.2022

Ilumetri

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

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/18/1323

21.6.2022

20.6.2022

OBIZUR

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/15/1035

21.6.2022

20.6.2022

Olumiant

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

21.6.2022

20.6.2022

Translarna

| PTC Therapeutics International Limited |
| --- |
| 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland |

PTC Therapeutics International Limited

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

EU/1/13/902

21.6.2022

21.6.2022

Cresemba

| Basilea Pharmaceutica Deutschland GmbH |
| --- |
| Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland |

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

EU/1/15/1036

22.6.2022

21.6.2022

Cuprymina

| A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L. |
| --- |
| Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia |

A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.

Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia

EU/1/12/784

22.6.2022

21.6.2022

Elonva

| N.V. Organon |
| --- |
| P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland |

N.V. Organon

P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland

EU/1/09/609

23.6.2022

21.6.2022

Entecavir Mylan

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

Mylan Pharmaceuticals Limited

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

EU/1/17/1227

22.6.2022

21.6.2022

Hepcludex

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1446

27.6.2022

21.6.2022

Hycamtin

| 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/1/96/027

22.6.2022

21.6.2022

KEYTRUDA

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

29.6.2022

21.6.2022

Lemtrada

| Sanofi Belgium |
| --- |
| Leonardo Da Vincilaan 19, B-1831 Diegem, België |

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem, België

EU/1/13/869

22.6.2022

21.6.2022

Mektovi

| Pierre Fabre Médicament |
| --- |
| Les Cauquillous, 81500 Lavaur, France |

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1315

22.6.2022

21.6.2022

Mysimba

| Orexigen Therapeutics Ireland Limited |
| --- |
| 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland |

Orexigen Therapeutics Ireland Limited

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

EU/1/14/988

23.6.2022

21.6.2022

NexoBrid

| MediWound Germany GmbH |
| --- |
| Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland |

MediWound Germany GmbH

Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland

EU/1/12/803

27.6.2022

21.6.2022

Pemetrexed Fresenius Kabi

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Fresenius Kabi Deutschland GmbH

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

EU/1/16/1115

27.6.2022

21.6.2022

Retsevmo

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

22.6.2022

21.6.2022

TOOKAD

| Steba Biotech S.A |
| --- |
| 7 Place du Théâtre, 2613 Luxembourg, Luxembourg |

Steba Biotech S.A

7 Place du Théâtre, 2613 Luxembourg, Luxembourg

EU/1/17/1228

23.6.2022

21.6.2022

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

22.6.2022

21.6.2022

Votubia

| 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/1/11/710

23.6.2022

21.6.2022

XALKORI

| 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/1/12/793

22.6.2022

21.6.2022

Xaluprine

| Nova Laboratories Ireland Limited |
| --- |
| 3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland |

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland

EU/1/11/727

27.6.2022

21.6.2022

Yescarta

| Kite Pharma EU B.V. |
| --- |
| Tufsteen 1, 2132 NT Hoofddorp, Nederland |

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/18/1299

23.6.2022

22.6.2022

KEYTRUDA

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

27.6.2022

24.6.2022

Abecma

| 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/1/21/1539

27.6.2022

24.6.2022

Azopt

| 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/1/00/129

27.6.2022

24.6.2022

Bretaris Genuair

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/781

27.6.2022

24.6.2022

Brimica Genuair

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/963

27.6.2022

24.6.2022

Deferasirox 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/1/19/1412

27.6.2022

24.6.2022

Defitelio

| Gentium S.r.I. |
| --- |
| Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia |

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

28.6.2022

24.6.2022

Defitelio

| Gentium S.r.I. |
| --- |
| Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia |

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

28.6.2022

24.6.2022

Dificlir

| Tillotts Pharma GmbH |
| --- |
| Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland |

Tillotts Pharma GmbH

Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland

EU/1/11/733

30.6.2022

24.6.2022

Duaklir Genuair

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/964

27.6.2022

24.6.2022

Eklira Genuair

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/778

27.6.2022

24.6.2022

Norvir

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/96/016

27.6.2022

24.6.2022

Ocaliva

| Intercept Pharma International Limited |
| --- |
| Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland |

Intercept Pharma International Limited

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

EU/1/16/1139

28.6.2022

24.6.2022

Onbevzi

| 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/1/20/1499

29.6.2022

24.6.2022

Oncaspar

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, 92284 Suresnes Cedex, France |

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/15/1070

27.6.2022

24.6.2022

Spravato

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/19/1410

27.6.2022

24.6.2022

Temodal

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/98/096

28.6.2022

24.6.2022

TRIXEO AEROSPHERE

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1498

27.6.2022

24.6.2022

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

28.6.2022

24.6.2022

Zometa

| Phoenix Labs Unlimited Company |
| --- |
| Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland |

Phoenix Labs Unlimited Company

Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland

EU/1/01/176

30.6.2022

29.6.2022

Alymsys

| Mabxience Research SL |
| --- |
| C/ Manuel Pombo Angulo 28 — 3a y 4a Planta, 28050 Madrid, España |

Mabxience Research SL

C/ Manuel Pombo Angulo 28 — 3a y 4a Planta, 28050 Madrid, España

EU/1/20/1509

4.7.2022

29.6.2022

Apixaban 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/1/20/1458

30.6.2022

29.6.2022

BLENREP

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/20/1474

30.6.2022

29.6.2022

Cerezyme

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/97/053

30.6.2022

29.6.2022

Dacogen

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/12/792

30.6.2022

29.6.2022

Epidyolex

| GW Pharma (International) B.V. |
| --- |
| Databankweg 26, 3821AL Amersfoort, Nederland |

GW Pharma (International) B.V.

Databankweg 26, 3821AL Amersfoort, Nederland

EU/1/19/1389

30.6.2022

29.6.2022

Isentress

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/436

30.6.2022

29.6.2022

LIBTAYO

| Regeneron Ireland Designated Activity Company (DAC) |
| --- |
| One Warrington Place, Dublin 2, D02 HH27 Ireland |

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

30.6.2022

29.6.2022

Optruma

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/98/074

1.7.2022

29.6.2022

PritorPlus

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/215

1.7.2022

29.6.2022

Respreeza

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

CSL Behring GmbH

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

EU/1/15/1006

1.7.2022

29.6.2022

Vizamyl

| GE Healthcare AS |
| --- |
| Nycoveien 1, 0485, Oslo, Norge |

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/14/941

30.6.2022

29.6.2022

Vizimpro

| 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/1/19/1354

30.6.2022

29.6.2022

Xerava

| PAION Deutschland GmbH |
| --- |
| Heussstraße 25, 52078 Aachen, Deutschland |

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/18/1312

30.6.2022

30.6.2022

Enspryng

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

Roche Registration GmbH

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

EU/1/21/1559

4.7.2022

—   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 |
| --- | --- | --- | --- | --- |
| 7.6.2022 | Episalvan | Amryt GMBH |
| Streiflingsweg 11, 75223 Niefern-Öschelbronn, 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

7.6.2022

Episalvan

Amryt GMBH

Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland

EU/1/15/1069

8.6.2022

24.6.2022

Senstend

| Plethora Pharma Solutions Ltd. |
| --- |
| 32 Merrion Street Upper, Dublin 2, Ireland |

Plethora Pharma Solutions Ltd.

32 Merrion Street Upper, Dublin 2, Ireland

EU/1/19/1387

28.6.2022

—   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 |
| --- | --- | --- | --- | --- |
| 3.6.2022 | Reconcile | FORTE Healthcare Ltd |
| Cougar Lane, Naul, Co. Dublin, Ireland |

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

3.6.2022

Reconcile

FORTE Healthcare Ltd

Cougar Lane, Naul, Co. Dublin, Ireland

EU/2/08/080

8.6.2022

3.6.2022

Syvazul BTV

| LABORATORIOS SYVA, S.A.U. |
| --- |
| Av. Párroco Pablo Diez 49-57, 24010 León, España |

LABORATORIOS SYVA, S.A.U.

Av. Párroco Pablo Diez 49-57, 24010 León, España

EU/2/18/231

30.6.2022

13.6.2022

Increxxa

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/20/258

14.6.2022

13.6.2022

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

20.6.2022

14.6.2022

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

20.6.2022

14.6.2022

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

20.6.2022

14.6.2022

Suprelorin

| VIRBAC S.A. |
| --- |
| 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France |

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France

EU/2/07/072

16.6.2022

20.6.2022

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

29.6.2022

20.6.2022

REXXOLIDE

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

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/20/263

27.6.2022

24.6.2022

Apoquel

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

Zoetis Belgium S.A.

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

EU/2/13/154

28.6.2022

24.6.2022

Emdocam

| Emdoka bvba |
| --- |
| J. Lijsenstraat 16, 2321 Hoogstraten, België |

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/11/128

30.6.2022

24.6.2022

Enteroporc Coli AC

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/262

27.6.2022

24.6.2022

Innovax-ND-IBD

| 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/2/17/213

28.6.2022

24.6.2022

Lydaxx

| VETOQUINOL S.A. |
| --- |
| Magny-Vernois, 70200 Lure, France |

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/253

30.6.2022

24.6.2022

Neptra

| Bayer Animal Health GmbH |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/19/246

30.6.2022

24.6.2022

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

27.6.2022

24.6.2022

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

28.6.2022

24.6.2022

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

28.6.2022

24.6.2022

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

27.6.2022

24.6.2022

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

27.6.2022

24.6.2022

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

27.6.2022

24.6.2022

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

27.6.2022

24.6.2022

Sileo

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

28.6.2022

24.6.2022

Vectormune ND

| CEVA-Phylaxia Co. Ltd |
| --- |
| Szállás u. 5, 1107 Budapest, Magyarország |

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

3.7.2022

24.6.2022

Zenalpha

| Vetcare Oy |
| --- |
| P.O. Box 99, 24101 Salo, Suomi |

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

27.6.2022

28.6.2022

CLYNAV

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/197

29.6.2022

29.6.2022

Porcilis PCV

| 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/2/08/091

1.7.2022

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.

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

---