# Official Journal C 96/28 F

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 96 |
| | |
| English edition | Information and Notices | Volume 6528 February 2022 |

ISSN 1977-091X

Official Journal

of the European Union

C 96

English edition

Information and Notices

Volume 6528 February 2022

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2022/C 96/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 31 December 2021(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2022/C 96/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2022 to 31 January 2022(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 6 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2022/C 96/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 31 December 2021(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2022/C 96/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2022 to 31 January 2022(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

6

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.2.2022 | EN | Official Journal of the European Union | C 96/1 |
| --- | --- | --- | --- |

28.2.2022

EN

Official Journal of the European Union

C 96/1

---

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

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

(2022/C 96/01)

—   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 |
| --- | --- | --- | --- | --- |
| 14.1.2021 | Emselex | zr pharma& GmbH |
| Hietzinger Hauptstrasse 37, 1130 Wien, Österreich |

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

14.1.2021

Emselex

zr pharma& GmbH

Hietzinger Hauptstrasse 37, 1130 Wien, Österreich

EU/1/04/294

2.9.2021

22.1.2021

Vizamyl

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

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/14/941

1.2.2021

25.5.2021

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

18.1.2022

5.7.2021

Helicobacter Test INFAI

| INFAI GmbH |
| --- |
| Riehler Straße 36, 50668 Köln, Deutschland |

INFAI GmbH

Riehler Straße 36, 50668 Köln, Deutschland

EU/1/97/045

29.7.2021

9.7.2021

Vihuma

| Octapharma AB |
| --- |
| Lars Forssells gata 23, 112 75 Stockholm, Sverige |

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/16/1168

29.7.2021

16.7.2021

Atazanavir Mylan

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

Mylan Pharmaceuticals Limited

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

EU/1/16/1091

31.8.2021

16.7.2021

Bondronat

| Atnahs Pharma Netherlands B.V. |
| --- |
| Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark |

Atnahs Pharma Netherlands B.V.

Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark

EU/1/96/012

18.8.2021

16.7.2021

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

20.7.2021

16.7.2021

Mysildecard

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

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/16/1134

8.9.2021

23.7.2021

Fluad Tetra

| Seqirus Netherlands B.V. |
| --- |
| Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland |

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/20/1433

26.8.2021

23.7.2021

Flucelvax Tetra

| Seqirus Netherlands B.V. |
| --- |
| Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland |

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/18/1326

26.8.2021

23.7.2021

Galafold

| Amicus Therapeutics Europe Limited |
| --- |
| Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland |

Amicus Therapeutics Europe Limited

Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland

EU/1/15/1082

28.7.2021

23.7.2021

Sildenafil Actavis

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/09/595

16.8.2021

23.7.2021

Xeljanz

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

Pfizer Europe MA EEIG

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

EU/1/17/1178

27.7.2021

28.7.2021

Leflunomide ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/10/654

1.9.2021

12.8.2021

Lenalidomide Mylan

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

Mylan Ireland Limited

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

EU/1/20/1490

23.9.2021

18.8.2021

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

18.10.2021

18.8.2021

Palynziq

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

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/19/1362

8.10.2021

20.8.2021

OBIZUR

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

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/15/1035

16.9.2021

15.9.2021

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

17.9.2021

16.9.2021

Luminity

| Lantheus EU Limited |
| --- |
| Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland |

Lantheus EU Limited

Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland

EU/1/06/361

19.10.2021

29.9.2021

Abilify

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

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/04/276

9.12.2021

29.9.2021

Cegfila

| 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/1/19/1409

13.10.2021

29.9.2021

Colobreathe

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

4.10.2021

29.9.2021

elmiron

| bene-Arzneimittel GmbH |
| --- |
| Herterichstraße 1-3, 81479 München, Deutschland |

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

5.10.2021

29.9.2021

Praxbind

| 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/1/15/1056

5.10.2021

29.9.2021

VPRIV

| 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/1/10/646

30.9.2021

29.9.2021

Zoledronic acid medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/779

15.10.2021

11.10.2021

Ibandronic acid Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/11/685

8.11.2021

19.10.2021

Natpar

| 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/1/15/1078

20.10.2021

19.10.2021

Rivastigmine HEXAL

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

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/09/589

26.11.2021

22.10.2021

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

9.11.2021

22.10.2021

Topotecan Hospira

| 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/1/10/633

25.10.2021

15.11.2021

Atazanavir Krka

| 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/1/19/1353

3.12.2021

15.11.2021

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

14.12.2021

15.11.2021

Revatio

| 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/1/05/318

22.12.2021

15.11.2021

Ulunar 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/1/14/917

17.11.2021

18.11.2021

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

1.12.2021

22.11.2021

Jylamvo

| Therakind (Europe) Limited |
| --- |
| Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland |

Therakind (Europe) Limited

Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland

EU/1/17/1172

22.12.2021

26.11.2021

Glustin

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/00/151

9.12.2021

26.11.2021

Lixiana

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

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

3.12.2021

9.12.2021

Imnovid

| 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/1/13/850

7.1.2022

9.12.2021

Relistor

| Bausch Health Ireland Limited |
| --- |
| 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland |

Bausch Health Ireland Limited

3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

EU/1/08/463

14.12.2021

13.12.2021

AJOVY

| Teva GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/19/1358

15.12.2021

13.12.2021

Micardis

| 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/1/98/090

14.1.2022

13.12.2021

Onbrez 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/1/09/593

14.1.2022

16.12.2021

PREVYMIS

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

17.1.2022

20.12.2021

Trazimera

| 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/1/18/1295

22.12.2021

—   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 |
| --- | --- | --- | --- | --- |
| 29.11.2021 | Glustin | Takeda Pharma A/S |
| Delta Park 45, 2665 Vallensbæk Strand, Danmark |

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

29.11.2021

Glustin

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/00/151

9.12.2021

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 26.3.2021 | Purevax RCPCh FeLV | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein, 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

26.3.2021

Purevax RCPCh FeLV

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/047

30.3.2021

13.7.2021

Coxevac

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/10/110

5.8.2021

30.7.2021

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

16.8.2021

30.7.2021

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

16.8.2021

16.8.2021

Suvaxyn CSF Marker

| 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/2/14/179

7.9.2021

18.8.2021

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

18.10.2021

25.10.2021

Felisecto Plus

| 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/2/19/238

24.11.2021

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

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

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

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| 28.2.2022 | EN | Official Journal of the European Union | C 96/6 |
| --- | --- | --- | --- |

28.2.2022

EN

Official Journal of the European Union

C 96/6

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2022 to 31 January 2022

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

(2022/C 96/02)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1.2022 | Lumykras | sotorasib | Amgen Europe B.V. |
| Minervum 7061, 4817 ZK Breda, Nederland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

6.1.2022

Lumykras

sotorasib

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/21/1603

Film-coated tablet

L01XX73

7.1.2022

6.1.2022

Riltrava Aerosphere

formoterol / glycopyrronium bromide / budesonide

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1604

Pressurised inhalation, suspension

R03AL11

7.1.2022

6.1.2022

Tecovirimat SIGA

tecovirimat

| SIGA Technologies Netherlands B.V. |
| --- |
| Prinsenhil 29, Breda 4825 AX, Nederland |

SIGA Technologies Netherlands B.V.

Prinsenhil 29, Breda 4825 AX, Nederland

EU/1/21/1600

Capsule, hard

J05AX24

7.1.2022

6.1.2022

Wegovy

semaglutide

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/21/1608

Solution for injection

A10BJ06

7.1.2022

11.1.2022

Lonapegsomatropin Ascendis Pharma

Lonapegsomatropin

| Ascendis Pharma Endocrinology Division A/S |
| --- |
| Tuborg Boulevard 12, 2900 Hellerup, Danmark |

Ascendis Pharma Endocrinology Division A/S

Tuborg Boulevard 12, 2900 Hellerup, Danmark

EU/1/21/1607

Powder and solvent for solution for injection

Pending

17.1.2022

11.1.2022

Tavneos

avacopan

| 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/1/21/1605

Capsule, hard

Pending

19.1.2022

11.1.2022

Voraxaze

glucarpidase

| SERB SAS |
| --- |
| 40 Avenue George V, 75008 Paris, France |

SERB SAS

40 Avenue George V, 75008 Paris, France

EU/1/21/1586

Powder for solution for injection

V03AF09

13.1.2022

24.1.2022

Vyepti

eptinezumab

| H. Lundbeck A/S |
| --- |
| Ottiliavej 9, 2500 Valby, Danmark |

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/21/1599

Concentrate for solution for infusion

N02CD05

25.1.2022

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| 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 |
| --- | --- | --- | --- | --- |
| 6.1.2022 | Nouryant | Kyowa Kirin Holdings B.V. |
| Bloemlaan 2, 2132 NP Hoofddorp, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

6.1.2022

Nouryant

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

—

11.1.2022

—   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 |
| --- | --- | --- | --- | --- |
| 3.1.2022 | COVID-19 Vaccine Janssen | 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

3.1.2022

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

4.1.2022

6.1.2022

ADYNOVI

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

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/17/1247

7.1.2022

6.1.2022

Arsenic trioxide Mylan

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

Mylan Ireland Limited

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

EU/1/20/1427

7.1.2022

6.1.2022

Bavencio

| Merck Europe B.V. |
| --- |
| Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

10.1.2022

6.1.2022

Braftovi

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

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1314

10.1.2022

6.1.2022

CRYSVITA

| 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

12.1.2022

6.1.2022

Darzalex

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

7.1.2022

6.1.2022

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

7.1.2022

6.1.2022

Elocta

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| 112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/15/1046

10.1.2022

6.1.2022

Emtricitabine /Tenofovir disoproxil Krka d.d.

| 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/1/17/1182

12.1.2022

6.1.2022

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

3.2.2022

6.1.2022

Inhixa

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

Techdow Pharma Netherlands B.V.

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

EU/1/16/1132

18.1.2022

6.1.2022

Metalyse

| 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/1/00/169

11.1.2022

6.1.2022

Noxafil

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

10.1.2022

6.1.2022

Nuwiq

| Octapharma AB |
| --- |
| Lars Forssells gata 23, 112 75 Stockholm, Sverige |

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

10.1.2022

6.1.2022

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

12.1.2022

6.1.2022

Sirturo

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

7.1.2022

6.1.2022

Tecfidera

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/13/837

7.1.2022

6.1.2022

Trydonis

| 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/1/18/1274

7.1.2022

6.1.2022

Vfend

| 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/1/02/212

7.1.2022

6.1.2022

Zytiga

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/714

7.1.2022

7.1.2022

Epclusa

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

10.1.2022

7.1.2022

Kaftrio

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/20/1468

10.1.2022

7.1.2022

Kalydeco

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/12/782

10.1.2022

7.1.2022

Ledaga

| Helsinn Birex Pharmaceuticals Ltd. |
| --- |
| Damastown, Mulhuddart, Dublin 15, Ireland |

Helsinn Birex Pharmaceuticals Ltd.

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/16/1171

10.1.2022

7.1.2022

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

11.1.2022

7.1.2022

Rolufta Ellipta

| 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/1/17/1174

11.1.2022

7.1.2022

YERVOY

| 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/1/11/698

13.1.2022

11.1.2022

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

13.1.2022

11.1.2022

elmiron

| bene-Arzneimittel GmbH |
| --- |
| Herterichstraße 1-3, 81479 München, Deutschland |

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

12.1.2022

11.1.2022

Ozempic

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/17/1251

12.1.2022

11.1.2022

Yargesa

| Piramal Critical Care B.V. |
| --- |
| Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland |

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland

EU/1/17/1176

13.1.2022

12.1.2022

Multaq

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/09/591

13.1.2022

12.1.2022

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

13.1.2022

14.1.2022

COVID-19 Vaccine Janssen

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

14.1.2022

14.1.2022

Lonquex

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

18.1.2022

14.1.2022

Vaxzevria

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

14.1.2022

20.1.2022

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

21.1.2022

20.1.2022

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

24.1.2022

20.1.2022

Inhixa

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

Techdow Pharma Netherlands B.V.

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

EU/1/16/1132

21.1.2022

20.1.2022

Lumigan

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, County Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/02/205

25.1.2022

20.1.2022

Plenadren

| 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/1/11/715

24.1.2022

20.1.2022

Pradaxa

| 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/1/08/442

24.1.2022

20.1.2022

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

21.1.2022

24.1.2022

Bridion

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/466

25.1.2022

24.1.2022

Cinryze

| Shire Services BVBA |
| --- |
| rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België |

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688

25.1.2022

24.1.2022

Circadin

| 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/1/07/392

26.1.2022

24.1.2022

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

24.1.2022

24.1.2022

Exjade

| 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/1/06/356

25.1.2022

24.1.2022

Fotivda

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

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1215

28.1.2022

24.1.2022

Javlor

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

PIERRE FABRE MEDICAMENT

Les Cauquillous, 81500 Lavaur, France

EU/1/09/550

25.1.2022

24.1.2022

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

25.1.2022

24.1.2022

Kymriah

| 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/1/18/1297

25.1.2022

24.1.2022

Lokelma

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

25.1.2022

24.1.2022

NUCEIVA

| Evolus Pharma B.V. |
| --- |
| Apollolaan 151, 1077 AR Amsterdam, Nederland |

Evolus Pharma B.V.

Apollolaan 151, 1077 AR Amsterdam, Nederland

EU/1/19/1364

7.2.2022

24.1.2022

Oslif 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/1/09/586

25.1.2022

24.1.2022

Pregabalin Sandoz GmbH

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1012

25.1.2022

24.1.2022

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

25.1.2022

24.1.2022

Teysuno

| Nordic Group B.V. |
| --- |
| Siriusdreef 41, 2132 WT Hoofddorp, Nederland |

Nordic Group B.V.

Siriusdreef 41, 2132 WT Hoofddorp, Nederland

EU/1/11/669

26.1.2022

24.1.2022

Ultibro 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/1/13/862

25.1.2022

24.1.2022

Vizarsin

| 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/1/09/551

26.1.2022

24.1.2022

Zynquista

| Guidehouse Germany GmbH |
| --- |
| Albrechtstrasse 10c, 10117 Berlin, Deutschland |

Guidehouse Germany GmbH

Albrechtstrasse 10c, 10117 Berlin, Deutschland

EU/1/19/1363

29.1.2022

25.1.2022

Actraphane

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/229

31.1.2022

25.1.2022

Actrapid

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/230

26.1.2022

25.1.2022

Fasenra

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

27.1.2022

25.1.2022

Lantus

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134

26.1.2022

25.1.2022

Prolia

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

27.1.2022

25.1.2022

Sixmo

| L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A |
| --- |
| Strada Statale 67, 50018 Scandicci (Firenze), Italia |

L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A

Strada Statale 67, 50018 Scandicci (Firenze), Italia

EU/1/19/1369

27.1.2022

27.1.2022

Arsenic trioxide medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/20/1475

31.1.2022

27.1.2022

Desloratadine ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/746

30.1.2022

27.1.2022

Gilenya

| 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/1/11/677

28.1.2022

27.1.2022

Libmeldy

| Orchard Therapeutics (Netherlands) B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland |

Orchard Therapeutics (Netherlands) B.V.

Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland

EU/1/20/1493

31.1.2022

27.1.2022

Lorviqua

| 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/1/19/1355

28.1.2022

27.1.2022

Pemetrexed 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/1/15/1071

28.1.2022

27.1.2022

Staquis

| 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/1/19/1421

28.1.2022

27.1.2022

Telmisartan Teva Pharma

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

28.1.2022

27.1.2022

Zinforo

| Pfizer Ireland Pharmaceuticals |
| --- |
| Operations Support Group, Ringaskiddy, County Cork, Ireland |

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

28.1.2022

27.1.2022

Zonegran

| Amdipharm Limited |
| --- |
| 3 Burlington Road, Dublin 4, D04 RD68, IRELAND |

Amdipharm Limited

3 Burlington Road, Dublin 4, D04 RD68, IRELAND

EU/1/04/307

28.1.2022

31.1.2022

Avastin

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

Roche Registration GmbH

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

EU/1/04/300

1.2.2022

31.1.2022

Benepali

| 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/1/15/1074

4.2.2022

31.1.2022

Besremi

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

AOP Orphan Pharmaceuticals GmbH,

Leopold-Ungar-Platz 2, 1190 Wien, Österreich

EU/1/18/1352

2.2.2022

31.1.2022

Entyvio

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/14/923

2.2.2022

31.1.2022

Ervebo

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1392

2.2.2022

31.1.2022

Fareston

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

1.2.2022

31.1.2022

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

1.2.2022

31.1.2022

Luveris

| Merck Europe B.V. |
| --- |
| Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/155

2.2.2022

31.1.2022

Mulpleo

| Shionogi B.V. |
| --- |
| Kingsfordweg 151, 1043 GR Amsterdam, Nederland |

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/18/1348

1.2.2022

31.1.2022

Pemetrexed Hospira

| 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/1/15/1057

1.2.2022

31.1.2022

Rhokiinsa

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

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/19/1400

2.2.2022

31.1.2022

Spinraza

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

1.2.2022

31.1.2022

Tivicay

| 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/1/13/892

1.2.2022

—   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 |
| --- | --- | --- | --- | --- |
| 31.1.2022 | Staquis | Pfizer Europe MA EEIG |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, 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

31.1.2022

Staquis

Pfizer Europe MA EEIG

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

EU/1/19/1421

1.2.2022

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.1.2022 | CircoMax | Porcine circovirus vaccine (inactivated, recombinant) | Zoetis Belgium S.A. |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

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

11.1.2022

CircoMax

Porcine circovirus vaccine (inactivated, recombinant)

Zoetis Belgium S.A.

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

EU/2/21/281

Emulsion for injection

QI09AA07

12.1.2022

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.1.2022 | Meloxidolor | Le Vet Beheer B.V. |
| Wilgenweg 7, 3421 TV Oudewater, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.1.2022

Meloxidolor

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/13/148

11.1.2022

4.1.2022

Sileo

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

5.1.2022

4.1.2022

VarroMed

| BeeVital GmbH |
| --- |
| Wiesenbergstrasse 19,A- 5164, Seeham, Österreich |

BeeVital GmbH

Wiesenbergstrasse 19,A- 5164, Seeham, Österreich

EU/2/16/203

17.1.2022

11.1.2022

Innovax-ILT

| 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/2/15/182

13.1.2022

11.1.2022

Vectormune FP ILT + AE

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

Ceva-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/20/250

17.1.2022

20.1.2022

Improvac

| 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/2/09/095

21.1.2022

24.1.2022

Suvaxyn Aujeszky 783 + O/W

| 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/2/98/009

25.1.2022

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

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

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