ISSN 1977-091X

Official Journal

of the European Union

C 213

European flag  

English edition

Information and Notices

Volume 63
26 June 2020


Contents

page

 

IV   Notices

 

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

 

European Commission

2020/C 213/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2018 to 31 December 2019(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 213/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2020 to 31 May 2020(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

3


EN

 


IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

26.6.2020   

EN

Official Journal of the European Union

C 213/1


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2018 to 31 December 2019

(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 213/01)

—   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

29.10.2018

Eporatio

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/09/573

31.10.2018

29.10.2018

Viramune

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/055

31.10.2018

28.11.2018

Keppra

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/00/146

30.11.2018

28.11.2018

Pioglitazone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/757

30.11.2018

28.11.2018

Pioglitazone Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/758

30.11.2018

28.11.2018

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

30.11.2018

20.12.2018

Vimizim

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/14/914

24.1.2019

11.4.2019

Apidra

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/04/285

16.4.2019

15.4.2019

Orencia

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/389

17.4.2019

6.6.2019

Glustin

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/151

11.6.2019

27.6.2019

Xeljanz

Pfizer Europe MA EEIG

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

EU/1/17/1178

1.7.2019

23.8.2019

NutropinAq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/00/164

27.8.2019

23.9.2019

Zebinix

Bial — Portela & Ca, SA

À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

EU/1/09/514

25.9.2019

29.10.2019

Inhixa

Techdow Pharma Netherlands B.V.

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

EU/1/16/1132

15.11.2019

22.11.2019

Flixabi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/16/1106

26.11.2019

—   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

26.4.2019

ERYSENG

Laboratorios Hipra, S.A.

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

EU/2/14/166

30.4.2019

29.8.2019

BROADLINE

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/13/157

2.9.2019

29.8.2019

VarroMed

BeeVital GmbH

Wiesenbergstrasse 19,A- 5164, Seeham, Österreich

EU/2/16/203

2.9.2019

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

NETHERLANDS


(1)  OJ L 136, 30.4.2004, p. 1.


26.6.2020   

EN

Official Journal of the European Union

C 213/3


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2020 to 31 May 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 213/02)

—   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

18.5.2020

Zolgensma

onasemnogene abeparvovec

AveXis EU Limited

Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland

EU/1/20/1443

Solution for infusion

M09AX09

18.5.2020

20.5.2020

Fluad Tetra

influenza vaccine (surface antigen, inactivated, adjuvanted)

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands

EU/1/20/1433

Suspension for injection in pre-filled syringe (injection).

J07BB02

26.5.2020

20.5.2020

Nepexto

etanercept

Mylan IRE Healthcare Limited

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

EU/1/20/1436

Solution for injection

L04AB01

29.5.2020

30.5.2020

Atectura Breezhaler

indacaterol/mometasone furoate

Novartis Europharm Limited

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

EU/1/20/1439

Inhalation powder, hard capsule

R03AK14

2.6.2020

30.5.2020

Bemrist Breezhaler

indacaterol/mometasone furoate

Novartis Europharm Limited

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

EU/1/20/1441

Inhalation powder, hard capsule

R03AK

2.6.2020

30.5.2020

Sarclisa

isatuximab

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/20/1435

Concentrate for solution for infusion

L01XC38

3.6.2020

—   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

4.5.2020

Axura

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/02/218

8.5.2020

4.5.2020

Bortezomib Accord

Accord Healthcare S.L.U.

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

EU/1/15/1019

12.5.2020

4.5.2020

Bronchitol

Pharmaxis Europe Limited

108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland

EU/1/12/760

5.5.2020

4.5.2020

Clopidogrel Apotex

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/09/568

6.5.2020

4.5.2020

Clopidogrel Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/09/559

5.5.2020

4.5.2020

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

7.5.2020

4.5.2020

Cystadrops

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/15/1049

6.5.2020

4.5.2020

Ferriprox

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/99/108

7.5.2020

4.5.2020

Grepid

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

5.5.2020

4.5.2020

Ilumetri

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/18/1323

5.5.2020

4.5.2020

Pemetrexed Krka

KRKA, d.d.

Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/18/1283

12.5.2020

4.5.2020

Pemetrexed medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1038

12.5.2020

4.5.2020

Raxone

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Straße 8, 79539 Lörrach, Deutschland

EU/1/15/1020

14.5.2020

4.5.2020

Tafinlar

Novartis Europharm Limited

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

EU/1/13/865

8.5.2020

4.5.2020

Wilzin

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/04/286

5.5.2020

4.5.2020

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

6.5.2020

5.5.2020

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

6.5.2020

12.5.2020

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

19.5.2020

12.5.2020

Clopidogrel Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

13.5.2020

12.5.2020

Movymia

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/16/1161

13.5.2020

12.5.2020

Pemetrexed Hospira

Pfizer Europe MA EEIG

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

EU/1/15/1057

14.5.2020

12.5.2020

Segluromet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1265

14.5.2020

12.5.2020

Steglatro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1267

14.5.2020

12.5.2020

Steglujan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

14.5.2020

12.5.2020

Vedrop

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/09/533

13.5.2020

14.5.2020

Clopidogrel Krka d.d.

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

18.5.2020

14.5.2020

Firdapse

SERB S.A.

Avenue Louise 480, 1050 Bruxelles, Belgique/Louizalaan 480, 1050 Brussel, België

EU/1/09/601

15.5.2020

14.5.2020

Yellox

Bausch Health Ireland Limited

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

EU/1/11/692

15.5.2020

18.5.2020

Signifor

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/12/753

19.5.2020

20.5.2020

Daxas

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/636

28.5.2020

20.5.2020

Ivabradine Anpharm

ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.

ul. Annopol 6B, 03–236 Warszawa, Polska

EU/1/15/1041

25.5.2020

20.5.2020

Jorveza

Dr Falk Pharma GmbH

Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland

EU/1/17/1254

26.5.2020

20.5.2020

Lenvima

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/15/1002

26.5.2020

20.5.2020

LIBTAYO

Regeneron Ireland Designated Activity Company (DAC)

Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland

EU/1/19/1376

26.5.2020

20.5.2020

Nplate

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497

25.5.2020

20.5.2020

Odomzo

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/15/1030

28.5.2020

20.5.2020

Onpattro

Alnylam Netherlands B.V.

Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland

EU/1/18/1320

25.5.2020

20.5.2020

Pregabalin Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

25.5.2020

20.5.2020

Revestive

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland

EU/1/12/787

11.6.2020

20.5.2020

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

25.5.2020

—   Modification of a marketing authorization (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 authorization

Number of the entry in the Community Register

Date of notification

20.5.2020

Emgality

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1330

27.5.2020

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

18.5.2020

Lydaxx

tulathromycin

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/253

Solution for injection

QJ01FA94

19.5.2020

—   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

4.5.2020

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

7.5.2020

4.5.2020

Loxicom

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate, Monaghan, Ireland

EU/2/08/090

7.5.2020

12.5.2020

Equilis Prequenza Te

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/057

15.5.2020

18.5.2020

Equilis Prequenza

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/056

20.5.2020

18.5.2020

Equilis Te

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/055

20.5.2020

27.5.2020

CYTOPOINT

Zoetis Belgium S.A.

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

EU/2/17/205

27.5.2020

27.5.2020

Porcilis PCV ID

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/187

2.6.2020

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


(1)  OJ L 136, 30.4.2004, p. 1.