Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2021. do 31. listopada 2021.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

(2021/C 478/01)

— Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

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.

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.

Memantine LEK

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/13/826

21.10.2021.

19.10.2021.

Memantine Mylan

Mylan Pharmaceuticals Limited

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

EU/1/13/827

20.10.2021.

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.

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.

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

29.10.2021.

— Povlačenje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

— Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1) SL L 136, 30.4.2004, str. 1.