ISSN 1977-1029

Jurnalul Oficial

al Uniunii Europene

C 478
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Ediţia în limba română

Comunicări şi informări

Anul 64
26 noiembrie 2021

Cuprins

Pagina

 

IV   Informări

 

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

 

Comisia Europeană

2021/C 478/01

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 octombrie 2021 până la 31 octombrie 2021[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

1

RO

 

IV Informări

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

26.11.2021   

RO

Jurnalul Oficial al Uniunii Europene

C 478/1

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 octombrie 2021 până la 31 octombrie 2021

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului (1)]

(2021/C 478/01)

—   Modificarea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

1.10.2021

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

1.10.2021

4.10.2021

Docetaxel Accord

Accord Healthcare S.L.U.

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

EU/1/12/769

5.10.2021

4.10.2021

Docetaxel Kabi

Fresenius Kabi Deutschland GmbH

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

EU/1/12/770

6.10.2021

4.10.2021

Posaconazole Accord

Accord Healthcare S.L.U.

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

EU/1/19/1379

5.10.2021

4.10.2021

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

4.10.2021

5.10.2021

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

5.10.2021

5.10.2021

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

5.10.2021

11.10.2021

Copalia

Novartis Europharm Limited

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

EU/1/06/372

12.10.2021

11.10.2021

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

11.10.2021

11.10.2021

Dafiro

Novartis Europharm Limited

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

EU/1/06/371

12.10.2021

11.10.2021

Entecavir Mylan

Mylan Pharmaceuticals Limited

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

EU/1/17/1227

12.10.2021

11.10.2021

Equidacent

Centus Biotherapeutics Europe Limited

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

EU/1/20/1472

8.11.2021

11.10.2021

Exforge

Novartis Europharm Limited

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

EU/1/06/370

12.10.2021

11.10.2021

Onpattro

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/18/1320

13.10.2021

11.10.2021

Ovitrelle

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/165

12.10.2021

11.10.2021

ReFacto AF

Pfizer Europe MA EEIG

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

EU/1/99/103

12.10.2021

11.10.2021

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050

14.10.2021

11.10.2021

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

27.10.2021

11.10.2021

Vyndaqel

Pfizer Europe MA EEIG

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

EU/1/11/717

12.10.2021

15.10.2021

Vaxzevria

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

15.10.2021

19.10.2021

Ammonaps

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/99/120

20.10.2021

19.10.2021

Busilvex

Pierre Fabre Médicament

45 place Abel Gance, 92654 Boulogne-Billancourt CEDEX, France

EU/1/03/254

20.10.2021

19.10.2021

Ceprotin

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

20.10.2021

19.10.2021

Clopidogrel/Acetylsalicylic acid Mylan

Mylan Pharmaceuticals Limited

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

EU/1/19/1395

20.10.2021

19.10.2021

Duloxetine Mylan

Mylan Pharmaceuticals Limited

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

EU/1/15/1010

21.10.2021

19.10.2021

Ecalta

Pfizer Europe MA EEIG

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

EU/1/07/416

20.10.2021

19.10.2021

Erelzi

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

20.10.2021

19.10.2021

Firmagon

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark

EU/1/08/504

25.10.2021

19.10.2021

Forsteo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/03/247

25.10.2021

19.10.2021

Gazyvaro

Roche Registration GmbH

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

EU/1/14/937

20.10.2021

19.10.2021

Gefitinib Mylan

Mylan Pharmaceuticals Limited

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

EU/1/18/1321

20.10.2021

19.10.2021

Hefiya

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

20.10.2021

19.10.2021

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

21.10.2021

19.10.2021

Inrebic

Bristol-Myers Squibb Pharma EEIG

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

EU/1/20/1514

21.10.2021

19.10.2021

Integrilin

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/109

20.10.2021

19.10.2021

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

21.10.2021

19.10.2021

Lopinavir/Ritonavir Mylan

Mylan Pharmaceuticals Limited

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

EU/1/15/1067

21.10.2021

19.10.2021

Memantina Mylan

Mylan Pharmaceuticals Limited

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

EU/1/13/827

20.10.2021

19.10.2021

Memantine LEK

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/13/826

21.10.2021

19.10.2021

Mirapexin

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051

21.10.2021

19.10.2021

Myozyme

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/333

25.10.2021

19.10.2021

NovoEight

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/13/888

21.10.2021

19.10.2021

NovoMix

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/00/142

21.10.2021

19.10.2021

Noxafil

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

21.10.2021

19.10.2021

OPDIVO

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

9.11.2021

19.10.2021

Prasugrel Mylan

Mylan Pharmaceuticals Limited

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

EU/1/18/1273

20.10.2021

19.10.2021

Rasagiline Mylan

Mylan Pharmaceuticals Limited

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

EU/1/16/1090

20.10.2021

19.10.2021

REKAMBYS

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1482

20.10.2021

19.10.2021

Repaglinide Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/579

21.10.2021

19.10.2021

Semglee

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1270

20.10.2021

19.10.2021

Spedra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/13/841

21.10.2021

19.10.2021

Sunosi

Jazz Pharmaceuticals Ireland Ltd

5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland

EU/1/19/1408

21.10.2021

19.10.2021

Tasmar

Meda AB

Pipers väg 2A, 170 09 Solna, Sverige

EU/1/97/044

21.10.2021

19.10.2021

Tenofovir disoproxil Mylan

Mylan Pharmaceuticals Limited

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

EU/1/16/1129

20.10.2021

19.10.2021

Torisel

Pfizer Europe MA EEIG

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

EU/1/07/424

20.10.2021

19.10.2021

Vaborem

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/18/1334

20.10.2021

19.10.2021

Vfend

Pfizer Europe MA EEIG

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

EU/1/02/212

21.10.2021

19.10.2021

Vocabria

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/20/1481

20.10.2021

19.10.2021

Xydalba

Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland

EU/1/14/986

20.10.2021

19.10.2021

Zessly

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1280

20.10.2021

22.10.2021

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

5.11.2021

22.10.2021

Alofisel

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/17/1261

28.10.2021

22.10.2021

Betaferon

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/95/003

5.11.2021

22.10.2021

Biktarvy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/18/1289

27.10.2021

22.10.2021

Clopidogrel ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

26.10.2021

22.10.2021

Hyrimoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

25.10.2021

22.10.2021

Idacio

Fresenius Kabi Deutschland GmbH

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

EU/1/19/1356

25.10.2021

22.10.2021

Imcivree

Rhythm Pharmaceuticals Netherlands B.V.

Herengracht 280, 1016 BX Amsterdam, Nederland

EU/1/21/1564

26.10.2021

22.10.2021

Inflectra

Pfizer Europe MA EEIG

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

EU/1/13/854

25.10.2021

22.10.2021

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

25.10.2021

22.10.2021

Retacrit

Pfizer Europe MA EEIG

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

EU/1/07/431

25.10.2021

22.10.2021

Steglatro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1267

25.10.2021

22.10.2021

Veltassa

Vifor Fresenius Medical Care Renal Pharma France

100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

EU/1/17/1179

9.11.2021

22.10.2021

Zepatier

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1119

25.10.2021

25.10.2021

Clopidogrel Taw Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/09/559

26.10.2021

25.10.2021

Clopidogrel Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/09/568

1.11.2021

25.10.2021

Firazyr

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/08/461

27.10.2021

25.10.2021

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

26.11.2021

25.10.2021

Latuda

Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.

Viale Amelia 70, 00181 Roma, Italia

EU/1/14/913

26.10.2021

25.10.2021

Nerlynx

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

EU/1/18/1311

10.11.2021

25.10.2021

Segluromet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1265

28.10.2021

25.10.2021

Zyllt

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553

27.10.2021

28.10.2021

Clopidogrel Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

2.11.2021

28.10.2021

Clopidogrel TAD

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland

EU/1/09/555

3.11.2021

28.10.2021

Darunavir Mylan

Mylan Pharmaceuticals Limited

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

EU/1/16/1140

5.11.2021

28.10.2021

Mysildecard

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/16/1134

29.10.2021

28.10.2021

Ontozry

Angelini Pharma S.p.A

Viale Amelia 70, 00181 Rome, Italia

EU/1/21/1530

29.10.2021

28.10.2021

Tyverb

Novartis Europharm Limited

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

EU/1/07/440

29.10.2021

28.10.2021

Voriconazole Accord

Accord Healthcare S.L.U.

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

EU/1/13/835

29.10.2021

29.10.2021

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

29.10.2021

—   Retragerea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

11.10.2021

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/611

12.10.2021

11.10.2021

Equidacent

Centus Biotherapeutics Europe Limited

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

EU/1/20/1472

8.11.2021

—   Modificarea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

18.10.2021

Oxyglobin

OPK Biotech Netherlands BV

Herikerbergweg 88, 1101CM Amsterdam, Nederland

EU/2/99/015

5.11.2021

25.10.2021

Activyl Tick Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/137

26.10.2021

25.10.2021

Canigen L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/183

26.10.2021

25.10.2021

Nobilis IB Primo QX

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/174

27.10.2021

25.10.2021

Tulissin

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

28.10.2021

25.10.2021

Vectra 3D

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/13/156

26.10.2021

Oricine este interesat să consulte raportul public de evaluare al medicamentului în cauză și deciziile aferente este invitat să contacteze:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1)  JO L 136, 30.4.2004, p. 1.