# Official Journal C 419/2022

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 419 |
| | |
| English edition | Information and Notices | Volume 6531 October 2022 |

ISSN 1977-091X

Official Journal

of the European Union

C 419

English edition

Information and Notices

Volume 6531 October 2022

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2022/C 419/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2022 to 30 September 2022
  (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council) | 1 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2022/C 419/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2022 to 30 September 2022
  (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  or Article 5 of Regulation (EU) 2019/6 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

or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council

1

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 31.10.2022 | EN | Official Journal of the European Union | C 419/1 |
| --- | --- | --- | --- |

31.10.2022

EN

Official Journal of the European Union

C 419/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2022 to 30 September 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 419/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 15.9.2022 | Amvuttra | vutrisiran | Alnylam Netherlands B.V. |
| Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland |

—

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

15.9.2022

Amvuttra

vutrisiran

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/22/1681

Solution for injection

N07XX18

16.9.2022

15.9.2022

Celdoxome pegylated liposomal

doxorubicin hydrochloride

| YES Pharmaceutical Development Services GmbH |
| --- |
| Bahnstrasse 42-46, 61381 Friedrichsdorf, Deutschland |

YES Pharmaceutical Development Services GmbH

Bahnstrasse 42-46, 61381 Friedrichsdorf, Deutschland

EU/1/22/1666

Concentrate for dispersion for infusion

L01DB01

22.9.2022

15.9.2022

ilLuzyce

lutetium (177Lu) chloride

| Billev Pharma ApS |
| --- |
| Slotsmarken 10, 2970 Hørsholm, Danmark |

Billev Pharma ApS

Slotsmarken 10, 2970 Hørsholm, Danmark

EU/1/22/1680

Radiopharmaceutical precursor, solution

V10X

16.9.2022

15.9.2022

Lupkynis

voclosporin

| Otsuka Pharmaceutical Netherlands B.V. |
| --- |
| Herikerbergweg 292, 1101 CT, Amsterdam, Nederland |

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/22/1678

Capsule, soft

L04AD03

19.9.2022

15.9.2022

Mounjaro

tirzepatide

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/22/1685

Solution for injection

Pending

19.9.2022

15.9.2022

NULIBRY

fosdenopterin

| Comharsa Life Sciences Limited |
| --- |
| 10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland |

Comharsa Life Sciences Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland

EU/1/22/1684

Powder for solution for injection

A16AX

16.9.2022

15.9.2022

Opdualag

nivolumab/relatlimab

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

Bristol Myers Squibb Pharma EEIG

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

EU/1/22/1679

Concentrate for solution for infusion

L01XY03

16.9.2022

15.9.2022

Vabysmo

Faricimab

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

Roche Registration GmbH

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

EU/1/22/1683

Solution for injection

S01LA09

16.9.2022

19.9.2022

Tezspire

tezepelumab

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1677

Solution for injection

R03DX11

20.9.2022

19.9.2022

Thalidomide Lipomed

Thalidomide

| Lipomed GmbH |
| --- |
| Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland |

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/22/1676

Coated tablet

L04AX02

26.9.2022

21.9.2022

CRYSVITA

Burosumab

| Kyowa Kirin Holdings B.V. |
| --- |
| Bloemlaan 2, 2132 NP Hoofddorp, Nederland |

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/17/1262

Solution for injection

M05BX

29.9.2022

| — | 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 |
| --- | --- | --- | --- | --- | --- |
| 1.9.2022 | Comirnaty | BioNTech Manufacturing GmbH |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

—

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

1.9.2022

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

1.9.2022

1.9.2022

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

1.9.2022

2.9.2022

Aprovel

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/046

5.9.2022

2.9.2022

CoAprovel

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/086

5.9.2022

2.9.2022

Copalia HCT

| 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/1/09/575

5.9.2022

2.9.2022

Dafiro HCT

| 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/1/09/574

5.9.2022

2.9.2022

Dupixent

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

5.9.2022

2.9.2022

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

5.9.2022

2.9.2022

Januvia

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/383

7.9.2022

2.9.2022

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

5.9.2022

2.9.2022

Tecartus

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

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/20/1492

5.9.2022

2.9.2022

Zolgensma

| 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/1/20/1443

12.9.2022

6.9.2022

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

7.9.2022

9.9.2022

Ceplene

| Laboratoires Delbert |
| --- |
| 49 rue Rouelle, 75015 Paris, FRANCE |

Laboratoires Delbert

49 rue Rouelle, 75015 Paris, FRANCE

EU/1/08/477

12.9.2022

12.9.2022

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

12.9.2022

13.9.2022

Buvidal

| Camurus AB |
| --- |
| Ideon Science Park, 223 70 Lund, Sverige |

Camurus AB

Ideon Science Park, 223 70 Lund, Sverige

EU/1/18/1336

14.9.2022

13.9.2022

Exforge HCT

| 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/1/09/569

14.9.2022

13.9.2022

GAVRETO

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

Roche Registration GmbH

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

EU/1/21/1555

15.9.2022

13.9.2022

Izba

| 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/1/13/905

14.9.2022

13.9.2022

JEMPERLI

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1538

14.9.2022

13.9.2022

Karvea

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/049

14.9.2022

13.9.2022

Karvezide

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/085

14.9.2022

13.9.2022

Ninlaro

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/16/1094

19.9.2022

13.9.2022

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

14.9.2022

13.9.2022

Temozolomide HEXAL

| Hexal AG |
| --- |
| Industriestraße 25, 83607 Holzkirchen, Deutschland |

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/10/616

19.9.2022

13.9.2022

Temozolomide Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/10/617

16.9.2022

13.9.2022

Tigecycline 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/1/19/1394

14.9.2022

13.9.2022

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

14.9.2022

15.9.2022

Corlentor

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

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/05/317

19.9.2022

15.9.2022

Fasenra

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

16.9.2022

15.9.2022

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

16.9.2022

15.9.2022

Intrarosa

| Endoceutics S.A. |
| --- |
| Rue Belliard 40, 1040 Bruxelles, Belgique/ Belliardstraat 40, 1040 Brussel, België |

Endoceutics S.A.

Rue Belliard 40, 1040 Bruxelles, Belgique/ Belliardstraat 40, 1040 Brussel, België

EU/1/17/1255

18.9.2022

15.9.2022

Kinpeygo

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18, 61118 Bad Vilbel, Deutschland |

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/22/1657

19.9.2022

15.9.2022

Nyxoid

| Mundipharma Corporation (Ireland) Limited |
| --- |
| Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland |

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/17/1238

16.9.2022

15.9.2022

Oxlumo

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

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/20/1496

16.9.2022

15.9.2022

PREZISTA

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/06/380

16.9.2022

15.9.2022

Procoralan

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

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/05/316

19.9.2022

15.9.2022

Stribild

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/830

19.9.2022

16.9.2022

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

19.9.2022

16.9.2022

EVUSHELD

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1651

16.9.2022

16.9.2022

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

19.9.2022

16.9.2022

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

19.9.2022

19.9.2022

Miglustat Gen.Orph

| Gen.Orph |
| --- |
| 185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France |

Gen.Orph

185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France

EU/1/17/1232

21.9.2022

19.9.2022

Reblozyl

| 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/1/20/1452

23.9.2022

19.9.2022

SomaKit TOC

| Advanced Accelerator Applications |
| --- |
| 20 rue Diesel, 01630 Saint-Genis-Pouilly, France |

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/16/1141

21.9.2022

19.9.2022

TAGRISSO

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

20.9.2022

19.9.2022

Tarceva

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

Roche Registration GmbH

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

EU/1/05/311

21.9.2022

21.9.2022

Betmiga

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

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/12/809

26.9.2022

21.9.2022

Cervarix

| 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/1/07/419

26.9.2022

21.9.2022

Dafiro

| 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/1/06/371

23.9.2022

21.9.2022

Daxas

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/636

23.9.2022

21.9.2022

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

26.9.2022

21.9.2022

Evrysdi

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

Roche Registration GmbH

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

EU/1/21/1531

23.9.2022

21.9.2022

InductOs

| Medtronic BioPharma B.V. |
| --- |
| Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland |

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland

EU/1/02/226

23.9.2022

21.9.2022

Inlyta

| 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/1/12/777

26.9.2022

21.9.2022

Lyrica

| Upjohn EESV |
| --- |
| Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland |

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/04/279

27.9.2022

21.9.2022

Mvasi

| Amgen Technology (Ireland) UC |
| --- |
| Pottery Road, Dun Laoghaire, Co. Dublin, Ireland |

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

26.9.2022

21.9.2022

Ocrevus

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

Roche Registration GmbH

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

EU/1/17/1231

23.9.2022

21.9.2022

Ozempic

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

23.9.2022

21.9.2022

Rubraca

| Clovis Oncology Ireland Limited |
| --- |
| Regus Dublin Airport, Skybridge House - Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland |

Clovis Oncology Ireland Limited

Regus Dublin Airport, Skybridge House - Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland

EU/1/17/1250

23.9.2022

21.9.2022

Tegsedi

| Akcea Therapeutics Ireland Ltd |
| --- |
| Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland |

Akcea Therapeutics Ireland Ltd

Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

EU/1/18/1296

23.9.2022

21.9.2022

Tesavel

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/435

26.9.2022

21.9.2022

Travatan

| 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/1/01/199

26.9.2022

21.9.2022

Tybost

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

28.9.2022

21.9.2022

Ultomiris

| Alexion Europe SAS |
| --- |
| 103-105 Rue Anatole France, 92300 Levallois-Perret, France |

Alexion Europe SAS

103-105 Rue Anatole France, 92300 Levallois-Perret, France

EU/1/19/1371

23.9.2022

21.9.2022

Verkazia

| Santen Oy |
| --- |
| Niittyhaankatu 20, 33720 Tampere, Suomi |

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/17/1219

26.9.2022

21.9.2022

Zabdeno

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1444

27.9.2022

26.9.2022

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

27.9.2022

26.9.2022

Gencebok

| Gennisium Pharma |
| --- |
| Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France |

Gennisium Pharma

Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France

EU/1/20/1465

28.9.2022

26.9.2022

Lamivudine / Zidovudine Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/663

27.9.2022

26.9.2022

Lutathera

| Advanced Accelerator Applications |
| --- |
| 20 rue Diesel, 01630 Saint-Genis-Pouilly, France |

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/17/1226

28.9.2022

26.9.2022

Pirfenidone axunio

| axunio Pharma GmbH |
| --- |
| Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland |

axunio Pharma GmbH

Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland

EU/1/22/1655

27.9.2022

26.9.2022

Pregabalin Pfizer

| Upjohn EESV |
| --- |
| Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland |

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/14/916

27.10.2022

26.9.2022

Rybrevant

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/21/1594

27.9.2022

26.9.2022

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

6.10.2022

27.9.2022

COVID-19 Vaccine (inactivated, adjuvanted) Valneva

| Valneva Austria GmbH |
| --- |
| Campus Vienna Biocenter 3, 1030 Wien, Österreich |

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/21/1624

29.9.2022

27.9.2022

Jorveza

| Dr Falk Pharma GmbH |
| --- |
| Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland |

Dr Falk Pharma GmbH

Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland

EU/1/17/1254

28.9.2022

29.9.2022

ABILIFY MAINTENA

| Otsuka Pharmaceutical Netherlands B.V. |
| --- |
| Herikerbergweg 292, 1101 CT, Amsterdam, Nederland |

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/13/882

3.10.2022

29.9.2022

Byooviz

| 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

4.10.2022

29.9.2022

CABOMETYX

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

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

30.9.2022

29.9.2022

Copalia

| 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/1/06/372

30.9.2022

29.9.2022

Dupixent

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

30.9.2022

29.9.2022

Efient

| SUBSTIPHARM |
| --- |
| 24 rue Erlanger, 75016 Paris, France |

SUBSTIPHARM

24 rue Erlanger, 75016 Paris, France

EU/1/08/503

30.9.2022

29.9.2022

Entresto

| 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/1/15/1058

3.10.2022

29.9.2022

Exforge

| 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/1/06/370

30.9.2022

29.9.2022

IVEMEND

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/437

3.10.2022

29.9.2022

Janumet

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/455

29.9.2022

29.9.2022

Lydisilka

| Estetra SRL |
| --- |
| Rue Saint Georges 5-7, 4000 Liège, Belgique |

Estetra SRL

Rue Saint Georges 5-7, 4000 Liège, Belgique

EU/1/21/1548

3.10.2022

29.9.2022

Paxlovid

| 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/1/22/1625

30.9.2022

29.9.2022

PHELINUN

| ADIENNE S.r.l.S.U. |
| --- |
| Via Galileo Galilei 19, 20867 Caponago (MB), Italia |

ADIENNE S.r.l.S.U.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/20/1487

30.9.2022

29.9.2022

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

30.9.2022

29.9.2022

Ristfor

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/620

29.9.2022

29.9.2022

Simbrinza

| 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/1/14/933

3.10.2022

29.9.2022

TAKHZYRO

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/18/1340

3.10.2022

29.9.2022

Vaniqa

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

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/01/173

3.10.2022

29.9.2022

Velmetia

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/456

30.9.2022

30.9.2022

Evrenzo

| 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

3.10.2022

30.9.2022

Lamivudine Teva Pharma B.V.

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

3.10.2022

| — | 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 |
| --- | --- | --- | --- | --- | --- |
| 15.9.2022 | Temozolomide HEXAL | Hexal AG |
| Industriestraße 25, 83607 Holzkirchen, Deutschland |

—

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

15.9.2022

Temozolomide HEXAL

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/10/616

19.9.2022

15.9.2022

Temozolomide Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/10/617

21.9.2022

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 13.9.2022 | Lotilaner Elanco | lotilaner | Elanco GmbH |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

—

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

13.9.2022

Lotilaner Elanco

lotilaner

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/22/288

Chewable tablet

QP53BE04

14.9.2022

| — | 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 |
| --- | --- | --- | --- | --- | --- |
| 2.9.2022 | Aivlosin | ECO Animal Health Europe Limited |
| 6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland |

—

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

2.9.2022

Aivlosin

ECO Animal Health Europe Limited

6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland

EU/2/04/044

14.9.2022

2.9.2022

Zenalpha

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

5.9.2022

13.9.2022

Equisolon

Le Vet B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/14/161

30.9.2022

13.9.2022

Poulvac E. coli

| 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/2/12/140

16.9.2022

13.9.2022

Suiseng Diff/A

| 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/2/21/278

15.9.2022

15.9.2022

Bonqat

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/21/273

16.9.2022

15.9.2022

Nobivac LeuFel

| VIRBAC |
| --- |
| 1ère avenue 2065 m LID, 06516 Carros, France |

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/17/217

28.9.2022

15.9.2022

Sileo

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

16.9.2022

19.9.2022

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

22.9.2022

26.9.2022

Clomicalm

| VIRBAC |
| --- |
| 1ère avenue 2065 m LID, 06516 Carros, France |

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/98/007

28.9.2022

26.9.2022

Leucofeligen FeLV/RCP

| VIRBAC |
| --- |
| 1ère avenue 2065 m LID, 06516 Carros, France |

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/09/097

28.9.2022

26.9.2022

Meloxoral

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

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/10/111

27.9.2022

26.9.2022

Vaxxitek HVT + IBD

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/02/032

28.9.2022

29.9.2022

Arti-Cell Forte

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/18/228

5.10.2022

29.9.2022

Bovilis Blue-8

| 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/2/17/218

30.9.2022

29.9.2022

Leucogen

| Virbac |
| --- |
| 1ère Avenue - 2065 m - L.I.D., 06516 Carros CEDEX, France |

Virbac

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

EU/2/09/096

4.10.2022

29.9.2022

PREVEXXION RN

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/254

4.10.2022

29.9.2022

PREVEXXION RN+HVT+IBD

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/255

4.10.2022

29.9.2022

Suvaxyn Circo + MH RTU

| 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/2/15/190

4.10.2022

| — | Withdrawal 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)









  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 |
| --- | --- | --- | --- | --- | --- |
| 29.9.2022 | Activyl Tick Plus | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

—

Withdrawal 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)

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

29.9.2022

Activyl Tick Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/137

30.9.2022

29.9.2022

Nobilis OR inac

| 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/2/02/036

30.9.2022

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.

---