# C_2020367EN.01000501.xml

| 30.10.2020 | EN | Official Journal of the European Union | C 367/5 |
| --- | --- | --- | --- |

30.10.2020

EN

Official Journal of the European Union

C 367/5

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2020 to 30 September 2020

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

(2020/C 367/02)

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.9.2020 | Arsenic trioxide medac | arsenic trioxide | medac Gesellschaft für klinische Spezialpräparate mbH |
| Theaterstraße 6, 22880 Wedel, Deutschland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

17.9.2020

Arsenic trioxide medac

arsenic trioxide

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/20/1475

Concentrate and solvent for solution for infusion

L01XX27

18.9.2020

24.9.2020

AYVAKYT

avapritinib

| Blueprint Medicines (Netherlands) B.V. |
| --- |
| Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland |

Blueprint Medicines (Netherlands) B.V.

Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland

EU/1/20/1473

Film-coated tablet

L01EX18

25.9.2020

24.9.2020

Equidacent

bevacizumab

| Centus Biotherapeutics Europe Limited |
| --- |
| 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland |

Centus Biotherapeutics Europe Limited

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

EU/1/20/1472

Concentrate for solution for infusion

L01XC07

25.9.2020

24.9.2020

Fampridine Accord

fampridine

| 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/1/20/1477

Prolonged-release tablet

N07XX07

29.9.2020

24.9.2020

Jyseleca

filgotinib

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1480

Film-coated tablet

L04AA45

25.9.2020

24.9.2020

Zynrelef

bupivacaine/meloxicam

| Heron Therapeutics, B.V. |
| --- |
| Herengracht 500, 1017 CB Amsterdam, Nederland |

Heron Therapeutics, B.V.

Herengracht 500, 1017 CB Amsterdam, Nederland

EU/1/20/1478

Prolonged-release solution for injection

Pending

25.9.2020

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.9.2020 | HyQvia | Baxalta Innovations GmbH |
| Industriestraße 67, 1221 Wien, Österreich |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.9.2020

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

5.9.2020

3.9.2020

Vimpat

| 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/1/08/470

4.9.2020

15.9.2020

ADCETRIS

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/12/794

16.9.2020

15.9.2020

CellCept

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

Roche Registration GmbH

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

EU/1/96/005

16.9.2020

15.9.2020

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

16.9.2020

15.9.2020

Hepsera

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/251

16.9.2020

15.9.2020

Herzuma

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

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1257

16.9.2020

15.9.2020

JETREA

| Inceptua AB |
| --- |
| Gustavslundsv. 143, 16751 Bromma, Sverige |

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/13/819

16.9.2020

15.9.2020

Levetiracetam Accord

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

Accord Healthcare S.L.U.

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

EU/1/11/712

16.9.2020

15.9.2020

Levetiracetam Actavis

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

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/713

16.9.2020

15.9.2020

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

17.9.2020

15.9.2020

Prasugrel Mylan

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

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1273

16.9.2020

15.9.2020

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

16.9.2020

15.9.2020

Stayveer

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/832

16.9.2020

15.9.2020

Thalidomide Celgene

| Celgene Europe B.V. |
| --- |
| Winthontlaan 6 N, 3526 KV Utrecht, Nederland |

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/443

16.9.2020

15.9.2020

Tremfya

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

16.9.2020

17.9.2020

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

18.9.2020

17.9.2020

Dengvaxia

| Sanofi Pasteur |
| --- |
| 14 Espace Henry Vallée, 69007 Lyon, France |

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/18/1338

18.9.2020

17.9.2020

Episalvan

| Amryt GMBH |
| --- |
| Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland |

Amryt GMBH

Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland

EU/1/15/1069

29.9.2020

17.9.2020

Genvoya

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

18.9.2020

17.9.2020

Hetlioz

| Vanda Pharmaceuticals Netherlands B.V., |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Vanda Pharmaceuticals Netherlands B.V.,

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/15/1008

19.9.2020

17.9.2020

Ivozall

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

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/19/1396

29.9.2020

17.9.2020

Kovaltry

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/15/1076

21.9.2020

17.9.2020

Lumark

| IDB Holland B.V. |
| --- |
| Weverstraat 17, 5111 PV Baarle-Nassau, Nederland |

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

21.9.2020

17.9.2020

Tadalafil Mylan

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

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/14/961

18.9.2020

17.9.2020

Tyverb

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

Novartis Europharm Limited

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

EU/1/07/440

18.9.2020

17.9.2020

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

21.9.2020

24.9.2020

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

25.9.2020

24.9.2020

Cinacalcet Mylan

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

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1054

28.9.2020

24.9.2020

Edistride

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

28.9.2020

24.9.2020

EndolucinBeta

| ITM Medical Isotopes GmbH |
| --- |
| Lichtenbergstraße 1, 85748 Garching, Deutschland |

ITM Medical Isotopes GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

EU/1/16/1105

28.9.2020

24.9.2020

Eylea

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

25.9.2020

24.9.2020

Inbrija

| Acorda Therapeutics Ireland Limited |
| --- |
| 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland |

Acorda Therapeutics Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/19/1390

5.10.2020

24.9.2020

Incruse Ellipta

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

2.10.2020

24.9.2020

Lenalidomide Accord

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

Accord Healthcare S.L.U.

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

EU/1/18/1316

28.9.2020

24.9.2020

Levetiracetam Actavis Group

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

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/738

29.10.2020

24.9.2020

Lymphoseek

| Navidea Biopharmaceuticals Europe Ltd. |
| --- |
| Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland |

Navidea Biopharmaceuticals Europe Ltd.

Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland

EU/1/14/955

25.9.2020

24.9.2020

Lynparza

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

28.9.2020

24.9.2020

Olazax

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/597

29.9.2020

24.9.2020

Plegridy

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

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/14/934

28.9.2020

24.9.2020

Revlimid

| Celgene Europe B.V. |
| --- |
| Winthontlaan 6 N, 3526 KV Utrecht, Nederland |

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/391

28.9.2020

24.9.2020

Saxenda

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

28.9.2020

24.9.2020

Spectrila

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

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1072

25.9.2020

24.9.2020

Vaxelis

| MCM Vaccine B.V. |
| --- |
| Robert Boyleweg 4, 2333 CG Leiden, Nederland |

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

9.10.2020

24.9.2020

Victoza

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/09/529

28.9.2020

24.9.2020

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

2.10.2020

24.9.2020

Yondelis

| Pharma Mar S.A. |
| --- |
| Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España |

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

EU/1/07/417

28.9.2020

24.9.2020

Zalviso

| Grünenthal GmbH |
| --- |
| Zieglerstraße 6, 52078, Aachen, Deutschland |

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/15/1042

5.10.2020

30.9.2020

Aripiprazole 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/1/15/1045

1.10.2020

30.9.2020

Blitzima

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

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1205

1.10.2020

30.9.2020

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

2.10.2020

30.9.2020

Eptifibatide 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/1/15/1065

1.10.2020

30.9.2020

Erelzi

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

1.10.2020

30.9.2020

Extavia

| 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/1/08/454

1.10.2020

30.9.2020

Exviera

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

2.10.2020

30.9.2020

Febuxostat 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/1/18/1347

1.10.2020

30.9.2020

Fiasp

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

1.10.2020

30.9.2020

Herceptin

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

Roche Registration GmbH

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

EU/1/00/145

1.10.2020

30.9.2020

Icandra

| 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/1/08/484

1.10.2020

30.9.2020

Kyntheum

| Leo Pharma A/S |
| --- |
| Industriparken 55, 2750 Ballerup, Danmark |

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/16/1155

2.10.2020

30.9.2020

Mepsevii

| Ultragenyx Germany GmbH |
| --- |
| Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland |

Ultragenyx Germany GmbH

Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland

EU/1/18/1301

1.10.2020

30.9.2020

Neparvis

| 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/1/16/1103

1.10.2020

30.9.2020

Ozempic

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

1.10.2020

30.9.2020

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

2.10.2020

30.9.2020

ReFacto AF

| 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/1/99/103

1.10.2020

30.9.2020

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

2.10.2020

30.9.2020

Simulect

| 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/1/98/084

1.10.2020

30.9.2020

Temozolomide HEXAL

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

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/10/616

1.10.2020

30.9.2020

Temozolomide Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/10/617

1.10.2020

30.9.2020

Xigduo

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

1.10.2020

30.9.2020

Zomarist

| 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/1/08/483

1.10.2020

—   Withdrawal of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 24.9.2020 | Vepacel | Ology Bioservices Ireland LTD |
| Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

24.9.2020

Vepacel

Ology Bioservices Ireland LTD

Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland

EU/1/12/752

2.10.2020

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.9.2020 | Increxxa | tulathromycin | Elanco GmbH |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

16.9.2020

Increxxa

tulathromycin

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/20/258

Solution for injection

QJ01FA94

17.9.2020

16.9.2020

Innovax-ND-ILT

Marek's disease vaccine, Newcastle disease vaccine & infectious laryngotracheitis vaccine (live recombinant)

| 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/2/20/256

Concentrate and solvent for suspension for injection

QI01AD17

17.9.2020

16.9.2020

Tulinovet

tulathromycin

| V.M.D.n.v. |
| --- |
| Hoge Mauw 900, 2370 Arendonk, Belgïe |

V.M.D.n.v.

Hoge Mauw 900, 2370 Arendonk, Belgïe

EU/2/20/257

Solution for injection

QJ01FA94

17.9.2020

18.9.2020

MHYOSPHERE PCV ID

Mycoplasma hyopneumoniae and porcine circovirus vaccine (inactivated, recombinant)

| 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/2/20/259

Emulsion for injection

QI09AL08

21.9.2020

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.9.2020 | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein, Deutschland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.9.2020

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/07/079

22.9.2020

16.9.2020

Osurnia

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

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/14/170

17.9.2020

16.9.2020

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

17.9.2020

30.9.2020

Imrestor

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/15/193

1.10.2020

30.9.2020

Vectra Felis

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/14/165

1.10.2020

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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