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Document 52021XC1126(04)

    Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2021. gada 1. oktobra līdz 2021. gada 31. oktobrim (publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

    PUB/2021/917

    OV 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   

    LV

    Eiropas Savienības Oficiālais Vēstnesis

    C 478/1

    Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2021. gada 1. oktobra līdz 2021. gada 31. oktobrim

    (publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 (1))

    (2021/C 478/01)

    —   Tirdzniecības atļaujas grozīšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    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.

    —   Tirdzniecības atļaujas izņemšana no aprites (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    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.

    —   Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    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.

    Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

    European Medicines Agency

    Domenico Scarlattilaan 6

    1083 HS Amsterdam

    NETHERLANDS

    (1)  OV L 136, 30.4.2004., 1. lpp.

    Top