# Official Journal C 180/2019

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 180 |
| | |
| English edition | Information and Notices | Volume 6224 May 2019 |

ISSN 1977-091X

Official Journal

of the European Union

C 180

English edition

Information and Notices

Volume 6224 May 2019

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2019/C 180/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  11 ) | 1 |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| 2019/C 180/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  11 or Article 38 of Directive 2001/82/EC
  22
  ) | 16 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2019/C 180/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  11 )

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

11 )

1

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

2019/C 180/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  11 or Article 38 of Directive 2001/82/EC
  22
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

11 or Article 38 of Directive 2001/82/EC

22

)

16

---

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 24.5.2019 | EN | Official Journal of the European Union | C 180/1 |
| --- | --- | --- | --- |

24.5.2019

EN

Official Journal of the European Union

C 180/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019

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

(2019/C 180/01)

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.4.2019 | Idacio | adalimumab | Fresenius Kabi Deutschland GmbH |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

2.4.2019

Idacio

adalimumab

Fresenius Kabi Deutschland GmbH

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

EU/1/19/1356

Solution for injection

L04AB04

4.4.2019

2.4.2019

Kromeya

adalimumab

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

Fresenius Kabi Deutschland GmbH

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

EU/1/19/1357

Solution for injection

L04AB04

4.4.2019

2.4.2019

Vizimpro

dacomitinib

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

Pfizer Europe MA EEIG

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

EU/1/19/1354

Film-coated tablet

L01XE47

4.4.2019

26.4.2019

Dectova

zanamivir

| GlaxoSmithKline Trading Services Limited |
| --- |
| Currabinny, Carrigaline, County Cork, Ireland |

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/18/1349

Solution for infusion

J05AH01

30.4.2019

26.4.2019

Ondexxya

andexanet alfa

| Portola Netherlands B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands |

Portola Netherlands B.V.

Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands

EU/1/18/1345

Powder for solution for infusion

V03AB38

30.4.2019

26.4.2019

Skyrizi

risankizumab

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1361

Solution for injection

L04AC

30.4.2019

26.4.2019

Zynquista

sotagliflozin

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/19/1363

Film-coated tablet

A10BK06

30.4.2019

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

—

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.4.2019 | Afinitor | Novartis Europharm Limited |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

2.4.2019

Afinitor

Novartis Europharm Limited

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

EU/1/09/538

4.4.2019

2.4.2019

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

4.4.2019

2.4.2019

Capecitabine 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/1/12/762

4.4.2019

2.4.2019

Clopidogrel BGR

| Laboratoires BIOGARAN |
| --- |
| 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France |

Laboratoires BIOGARAN

15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France

EU/1/09/558

4.4.2019

2.4.2019

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

4.4.2019

2.4.2019

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

4.4.2019

2.4.2019

Deltyba

| Otsuka Novel Products GmbH |
| --- |
| Erika-Mann-Straße 21, 80636 München, Deutschland |

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

4.4.2019

2.4.2019

Eliquis

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

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

4.4.2019

2.4.2019

Empliciti

| 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/1/16/1088

4.4.2019

2.4.2019

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

4.4.2019

2.4.2019

Gazyvaro

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

Roche Registration GmbH

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

EU/1/14/937

4.4.2019

2.4.2019

Irbesartan Zentiva

| Zentiva k.s. |
| --- |
| U kabelovny 130, 10237 Praha 10, Česká republika |

Zentiva k.s.

U kabelovny 130, 10237 Praha 10, Česká republika

EU/1/06/376

4.4.2019

2.4.2019

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

4.4.2019

2.4.2019

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

4.4.2019

2.4.2019

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

4.4.2019

2.4.2019

NULOJIX

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

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/694

4.4.2019

2.4.2019

Opdivo

| 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/1/15/1014

4.4.2019

2.4.2019

Steglatro

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1267

4.4.2019

2.4.2019

Steglujan

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

4.4.2019

2.4.2019

Sylvant

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/928

4.4.2019

2.4.2019

Vidaza

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

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/488

4.4.2019

2.4.2019

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

4.4.2019

2.4.2019

Zonisamide 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/1/16/1093

4.4.2019

2.4.2019

Zykadia

| 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/1/15/999

4.4.2019

8.4.2019

Actraphane

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/229

10.4.2019

8.4.2019

BiResp Spiromax

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

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

10.4.2019

8.4.2019

Capecitabine medac

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

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/802

10.4.2019

8.4.2019

DuoResp Spiromax

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

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

10.4.2019

8.4.2019

Iressa

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/526

10.4.2019

8.4.2019

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

10.4.2019

8.4.2019

Lynparza

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

10.4.2019

8.4.2019

M-M-RVAXPRO

| MSD VACCINS |
| --- |
| 162 avenue Jean Jaurès, 69007 Lyon, France |

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/337

10.4.2019

8.4.2019

Orencia

| 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/1/07/389

10.4.2019

8.4.2019

Riarify

| 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/1/18/1275

10.4.2019

8.4.2019

Ritemvia

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 10 62 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 10 62 Budapest, Magyarország

EU/1/17/1207

10.4.2019

8.4.2019

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

10.4.2019

8.4.2019

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

10.4.2019

8.4.2019

Viread

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/01/200

10.4.2019

8.4.2019

Zerit

| 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/1/96/009

10.4.2019

9.4.2019

Esbriet

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

Roche Registration GmbH

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

EU/1/11/667

11.4.2019

9.4.2019

Ifirmacombi

| Krka d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

11.4.2019

9.4.2019

Rituzena

| 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/1/17/1206

11.4.2019

9.4.2019

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

11.4.2019

11.4.2019

Aprovel

| Sanofi Clir SNC |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/97/046

15.4.2019

11.4.2019

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

15.4.2019

11.4.2019

CoAprovel

| Sanofi Clir SNC |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/98/086

15.4.2019

11.4.2019

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

15.4.2019

11.4.2019

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

15.4.2019

11.4.2019

Ebilfumin

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/14/915

15.4.2019

11.4.2019

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

15.4.2019

11.4.2019

Irbesartan/Hydrochlorothiazide Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

15.4.2019

11.4.2019

Irbesartan Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/576

15.4.2019

11.4.2019

Lamivudine Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/566

15.4.2019

11.4.2019

Leganto

| 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/1/11/695

15.4.2019

11.4.2019

Lokelma

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

15.4.2019

11.4.2019

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

15.4.2019

11.4.2019

Pemetrexed Lilly

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1034

15.4.2019

11.4.2019

Pregabalin Zentiva

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

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

15.4.2019

11.4.2019

Spherox

| CO.DON AG |
| --- |
| Warthestraße 21, 14513 Teltow, Deutschland |

CO.DON AG

Warthestraße 21, 14513 Teltow, Deutschland

EU/1/17/1181

15.4.2019

11.4.2019

Starlix

| 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/1/01/174

15.4.2019

11.4.2019

Truxima

| 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/1/16/1167

15.4.2019

11.4.2019

Zutectra

| Biotest Pharma GmbH |
| --- |
| Landsteinerstraße 5, 63303 Dreieich, Deutschland |

Biotest Pharma GmbH

Landsteinerstraße 5, 63303 Dreieich, Deutschland

EU/1/09/600

15.4.2019

15.4.2019

Ecansya

| 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/1/12/763

17.4.2019

15.4.2019

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

17.4.2019

15.4.2019

Ifirmasta

| 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/1/08/480

17.4.2019

15.4.2019

Irbesartan HCT Zentiva

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

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/377

17.4.2019

15.4.2019

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

17.4.2019

17.4.2019

Amlodipine/ Valsartan 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/1/16/1092

24.4.2019

17.4.2019

Caelyx

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/96/011

24.4.2019

17.4.2019

Cimzia

| 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/1/09/544

24.4.2019

17.4.2019

Clopidogrel Apotex

| Apotex Europe B.V. |
| --- |
| Archimedesweg 2, 2333 CN Leiden, Nederland |

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/09/568

24.4.2019

17.4.2019

Clopidogrel HCS

| HCS bvba |
| --- |
| H. Kennisstraat 53, 2650 Edegem, België |

HCS bvba

H. Kennisstraat 53, 2650 Edegem, België

EU/1/10/651

24.4.2019

17.4.2019

Cuprymina

| SPARKLE S.r.l. |
| --- |
| Località Cavallino, 62010 Montecosaro (MC), Italia |

SPARKLE S.r.l.

Località Cavallino, 62010 Montecosaro (MC), Italia

EU/1/12/784

24.4.2019

17.4.2019

Miglustat Dipharma

| Dipharma B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/18/1346

24.4.2019

17.4.2019

Pandemic influenza vaccine H5N1 AstraZeneca

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

24.4.2019

17.4.2019

Rydapt

| 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/1/17/1218

24.4.2019

17.4.2019

Semglee

| 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/1/18/1270

24.4.2019

17.4.2019

SonoVue

| Bracco International B.V. |
| --- |
| Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland |

Bracco International B.V.

Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland

EU/1/01/177

24.4.2019

17.4.2019

Zubsolv

| Orexo AB |
| --- |
| Box 303, 751 05 Uppsala, Sverige |

Orexo AB

Box 303, 751 05 Uppsala, Sverige

EU/1/17/1233

24.4.2019

24.4.2019

Orphacol

| Laboratoires CTRS |
| --- |
| 63 rue de l’Est, 92100 Boulogne-Billancourt, France |

Laboratoires CTRS

63 rue de l’Est, 92100 Boulogne-Billancourt, France

EU/1/13/870

26.4.2019

26.4.2019

Aimovig

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

Novartis Europharm Limited

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

EU/1/18/1293

30.4.2019

26.4.2019

Ameluz

| Biofrontera Bioscience GmbH |
| --- |
| Hemmelrather Weg 201, 51377 Leverkusen, Deutschland |

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, 51377 Leverkusen, Deutschland

EU/1/11/740

30.4.2019

26.4.2019

Kyprolis

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

30.4.2019

26.4.2019

Lonquex

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

30.4.2019

26.4.2019

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

30.4.2019

26.4.2019

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

30.4.2019

26.4.2019

Picato

| LEO Laboratories Ltd |
| --- |
| 285 Cashel Road, Crumlin, Dublin 12, Ireland |

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

30.4.2019

26.4.2019

RotaTeq

| MSD VACCINS |
| --- |
| 162 avenue Jean Jaurès, 69007 Lyon, France |

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/348

30.4.2019

26.4.2019

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

30.4.2019

29.4.2019

Abilify

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

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/04/276

1.5.2019

29.4.2019

ABILIFY MAINTENA

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

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/13/882

1.5.2019

29.4.2019

Aripiprazole Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1029

2.5.2019

29.4.2019

Humira

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

2.5.2019

29.4.2019

Kaletra

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/01/172

2.5.2019

29.4.2019

Lemtrada

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

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem, België

EU/1/13/869

2.5.2019

29.4.2019

Maviret

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

2.5.2019

29.4.2019

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

2.5.2019

29.4.2019

Natpar

| Shire Pharmaceuticals Ireland Limited |
| --- |
| Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland |

Shire Pharmaceuticals Ireland Limited

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

EU/1/15/1078

1.5.2019

29.4.2019

Norvir

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/96/016

2.5.2019

29.4.2019

Repatha

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

1.5.2019

30.4.2019

Zydelig

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/938

3.5.2019

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

—

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.4.2019 | Numient | Amneal Pharma Europe Ltd |
| 70 Sir John Rogerson’s Quay, Dublin 2, Ireland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

2.4.2019

Numient

Amneal Pharma Europe Ltd

70 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/15/1044

4.4.2019

10.4.2019

Rituzena

| 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/1/17/1206

12.4.2019

11.4.2019

Topotecan Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/552

15.4.2019

15.4.2019

Airexar Spiromax

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/16/1123

17.4.2019

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.4.2019 | Chanhold | selamectin | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, Ireland |

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

17.4.2019

Chanhold

selamectin

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/19/236

Spot-on solution

QP54AA05

24.4.2019

23.4.2019

Forceris

toltrazuril/gleptoferron

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

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/19/235

Suspension for injection

QP51AJ51

25.4.2019

26.4.2019

Felisecto Plus

selamectin/sarolaner

| 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

Spot-on solution

QP54AA55

30.4.2019

26.4.2019

ReproCyc ParvoFLEX

Porcine parvovirosis vaccine (inactivated)

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/19/237

Suspension for injection

QI09AA02

30.4.2019

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

—

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 |
| --- | --- | --- | --- | --- |
| 8.4.2019 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A. |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

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

8.4.2019

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

10.4.2019

8.4.2019

Versican Plus DHPPi/L4R

| 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/2/14/163

10.4.2019

8.4.2019

Versican Plus L4

| 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/2/14/171

10.4.2019

11.4.2019

Convenia

| 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/2/06/059

15.4.2019

11.4.2019

Suvaxyn PRRS MLV

| 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/2/17/215

15.4.2019

11.4.2019

Versican Plus Pi/L4

| 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/2/14/172

15.4.2019

23.4.2019

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

25.4.2019

26.4.2019

ERYSENG PARVO

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/14/167

30.4.2019

26.4.2019

ProZinc

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

30.4.2019

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 |
| NEDERLAND |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NEDERLAND

---

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

---

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

| 24.5.2019 | EN | Official Journal of the European Union | C 180/16 |
| --- | --- | --- | --- |

24.5.2019

EN

Official Journal of the European Union

C 180/16

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1)
  or Article 38 of Directive 2001/82/EC (2)
  )

(2019/C 180/02)

| — | Issuing, maintenance or modification of a national marketing authorisation |
| --- | --- |

—

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 2.4.2019 | Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group | sartan | Not applicable | Not applicable | 3.4.2019 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

2.4.2019

Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

sartan

Not applicable

Not applicable

3.4.2019

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---