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Document 52021XC1126(04)

    Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2021 to 31 October 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

    PUB/2021/917

    OJ C 478, 26.11.2021, p. 1–7 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    26.11.2021   

    EN

    Official Journal of the European Union

    C 478/1

    Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2021 to 31 October 2021

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

    (2021/C 478/01)

    —   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

    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

    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

    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

    —   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

    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

    —   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

    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

    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.

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