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Document 52020XC0925(04)

    Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. avgusta 2020 do 31. avgusta 2020 (Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

    PUB/2020/735

    UL C 318, 25.9.2020, p. 1–8 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    25.9.2020   

    SL

    Uradni list Evropske unije

    C 318/1

    Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. avgusta 2020 do 31. avgusta 2020

    (Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1))

    (2020/C 318/01)

    —   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

    Datum sprejetja sklepa

    Ime zdravila

    INN (mednarodno nelastniško ime)

    Imetnik dovoljenja za promet

    Registracijska številka v registru Skupnosti

    Farmacevtska oblika

    ATC (anatomsko terapevtska kemijska oznaka)

    Datum obvestila

    19.8.2020

    Aybintio

    bevacizumab

    Samsung Bioepis NL B.V.

    Olof Palmestraat 10, 2616 LR Delft, Nederland

    EU/1/20/1454

    Koncentrat za raztopino za infundiranje

    L01XC07

    20.8.2020

    19.8.2020

    Bavencio

    avelumab

    Merck Europe B.V.

    Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

    EU/1/17/1214

    Koncentrat za raztopino za infundiranje

    L01XC31

    25.8.2020

    19.8.2020

    Gencebok

    kofeinijev citrat

    Gennisium Pharma

    Faculté Cochin – Paris Biotech Santé, 24 rue du Faubourg St Jacques, 75014 Paris, France

    EU/1/20/1465

    Raztopina za infundiranje

    N06BC01

    20.8.2020

    19.8.2020

    Methylthioninium chloride Cosmo

    metiltioninijev klorid

    Cosmo Technologies Ltd

    Riverside II, Sir John Rogerson’s Quay, Dublin 2, Ireland

    EU/1/20/1470

    Tablete s podaljšanim sproščanjem

    V04CX

    20.8.2020

    21.8.2020

    Kaftrio

    ivacaftor (ivacaftorum) / tezacaftor (tezacaftorum) / elexacaftor (elexacaftorum)

    Vertex Pharmaceuticals (Ireland) Limited

    28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

    EU/1/20/1468

    Filmsko obložene tablete

    R07AX32

    21.8.2020

    25.8.2020

    BLENREP

    Belantamab-mafodotin

    GlaxoSmithKline (Ireland) Limited

    12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

    EU/1/20/1474

    Prašek za koncentrat za raztopino za infundiranje

    L01XC39

    26.8.2020

    25.8.2020

    Idefirix

    imlifidaza

    Hansa Biopharma AB

    P.O. Box 785, 220 07 Lund, Sverige

    EU/1/20/1471

    Prašek za koncentrat za raztopino za infundiranje

    L04AA

    1.9.2020

    27.8.2020

    Livogiva

    teriparatid

    Theramex Ireland Limited

    3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

    EU/1/20/1462

    Rztopina za injiciranje

    H05AA02

    28.8.2020

    27.8.2020

    Qutavina

    teriparatid

    EuroGenerics Holdings BV

    Locatellikade 1, 1076AZ Amsterdam, Nederland

    EU/1/20/1463

    Rztopina za injiciranje

    H05AA02.

    31.8.2020

    28.8.2020

    Cabazitaxel Accord

    kabazitaksel

    Accord Healthcare S.L.U.

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

    EU/1/20/1448

    Koncentrat za raztopino za infundiranje

    L01CD04

    31.8.2020

    —   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

    Datum sprejetja sklepa

    Ime zdravila

    Imetnik dovoljenja za promet

    Registracijska številka v registru Skupnosti

    Datum obvestila

    6.8.2020

    Panretin

    Amdipharm Limited

    3 Burlington Road, Dublin 4, D04 RD68, IRELAND

    EU/1/00/149

    7.8.2020

    6.8.2020

    Pramipexole Accord

    Accord Healthcare S.L.U.

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

    EU/1/11/728

    10.8.2020

    6.8.2020

    Raxone

    Santhera Pharmaceuticals (Deutschland) GmbH

    Marie-Curie Straße 8, 79539 Lörrach, Deutschland

    EU/1/15/1020

    12.8.2020

    6.8.2020

    Zavicefta

    Pfizer Ireland Pharmaceuticals

    Operations Support Group, Ringaskiddy, County Cork, Ireland

    EU/1/16/1109

    11.8.2020

    10.8.2020

    Colobreathe

    Teva B.V.

    Swensweg 5, 2031 GA Haarlem, Nederland

    EU/1/11/747

    14.8.2020

    10.8.2020

    Fotivda

    EUSA Pharma (Netherlands) B.V.

    Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland

    EU/1/17/1215

    3.9.2020

    10.8.2020

    Inflectra

    Pfizer Europe MA EEIG

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

    EU/1/13/854

    11.8.2020

    10.8.2020

    Jylamvo

    Therakind (Europe) Limited

    3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland

    EU/1/17/1172

    24.8.2020

    10.8.2020

    Levetiracetam Teva

    Teva B.V.

    Swensweg 5, 2031 GA Haarlem, Nederland

    EU/1/11/701

    17.8.2020

    10.8.2020

    Nucala

    GlaxoSmithKline Trading Services Limited

    Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

    EU/1/15/1043

    14.8.2020

    10.8.2020

    Onivyde pegylated liposomal

    Les Laboratoires Servier

    50 rue Carnot, 92284 Suresnes Cedex, France

    EU/1/16/1130

    11.8.2020

    10.8.2020

    Pemetrexed Hospira

    Pfizer Europe MA EEIG

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

    EU/1/15/1057

    10.8.2020

    13.8.2020

    Apealea

    Oasmia Pharmaceutical AB

    Vallongatan 1, 75228 Uppsala, Sverige

    EU/1/18/1292

    24.8.2020

    13.8.2020

    Armisarte

    Actavis Group PTC ehf.

    Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

    EU/1/15/1063

    22.8.2020

    13.8.2020

    Cresemba

    Basilea Pharmaceutica Deutschland GmbH

    Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

    EU/1/15/1036

    14.8.2020

    13.8.2020

    Duloxetine Zentiva

    Zentiva, k.s.

    U Kabelovny 130, 102 37 Praha 10, Česká republika

    EU/1/15/1028

    17.8.2020

    13.8.2020

    Imatinib Accord

    Accord Healthcare S.L.U.

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

    EU/1/13/845

    17.8.2020

    13.8.2020

    Qtrilmet

    AstraZeneca AB

    151 85 Södertälje, Sverige

    EU/1/19/1401

    17.8.2020

    13.8.2020

    Twynsta

    Boehringer Ingelheim International GmbH

    Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

    EU/1/10/648

    14.8.2020

    17.8.2020

    Circadin

    RAD Neurim Pharmaceuticals EEC SARL

    4 rue de Marivaux, 75002 Paris, France

    EU/1/07/392

    20.8.2020

    19.8.2020

    Elocta

    Swedish Orphan Biovitrum AB (publ)

    112 76 Stockholm, Sverige

    EU/1/15/1046

    21.8.2020

    19.8.2020

    Emend

    Merck Sharp & Dohme B.V.

    Waarderweg 39, 2031 BN Haarlem, Nederland

    EU/1/03/262

    24.8.2020

    19.8.2020

    IDELVION

    CSL Behring GmbH

    Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

    EU/1/16/1095

    24.8.2020

    19.8.2020

    IMBRUVICA

    Janssen-Cilag International NV

    Turnhoutseweg 30, 2340 Beerse, België

    EU/1/14/945

    24.8.2020

    19.8.2020

    Pemetrexed medac

    medac Gesellschaft für klinische Spezialpräparate mbH

    Theaterstraße 6, 22880 Wedel, Deutschland

    EU/1/15/1038

    20.8.2020

    19.8.2020

    Pemetrexed Sandoz

    Sandoz GmbH

    Biochemiestrasse 10, 6250 Kundl, Österreich

    EU/1/15/1037

    28.8.2020

    19.8.2020

    Praluent

    Sanofi-Aventis groupe

    54 rue La Boétie, 75008 Paris, France

    EU/1/15/1031

    20.8.2020

    19.8.2020

    Skilarence

    Almirall, S.A.

    Ronda General Mitre, 151, 08022 Barcelona, España

    EU/1/17/1201

    26.8.2020

    19.8.2020

    Tecentriq

    Roche Registration GmbH

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

    EU/1/17/1220

    20.8.2020

    21.8.2020

    Kalydeco

    Vertex Pharmaceuticals (Ireland) Limited

    28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

    EU/1/12/782

    21.8.2020

    25.8.2020

    Aimovig

    Novartis Europharm Limited

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

    EU/1/18/1293

    3.9.2020

    25.8.2020

    Axumin

    Blue Earth Diagnostics Ireland Ltd

    6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland

    EU/1/17/1186

    26.8.2020

    25.8.2020

    Ebymect

    AstraZeneca AB

    151 85 Södertälje, Sverige

    EU/1/15/1051

    1.9.2020

    25.8.2020

    Epclusa

    Gilead Sciences Ireland UC

    Carrigtohill, County Cork, T45 DP77, Ireland

    EU/1/16/1116

    26.8.2020

    25.8.2020

    Esperoct

    Novo Nordisk A/S

    Novo Allé, 2880 Bagsvaerd, Danmark

    EU/1/19/1374

    26.8.2020

    25.8.2020

    Latuda

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

    Viale Amelia 70, 00181 Roma, Italia

    EU/1/14/913

    4.9.2020

    25.8.2020

    Ninlaro

    Takeda Pharma A/S

    Dybendal Alle 10, 2630 Taastrup, Danmark

    EU/1/16/1094

    1.9.2020

    25.8.2020

    Ravicti

    Immedica Pharma AB

    SE-113 29 Stockholm, Sverige

    EU/1/15/1062

    26.8.2020

    25.8.2020

    RotaTeq

    MSD VACCINS

    162 avenue Jean Jaurès, 69007 Lyon, France

    EU/1/06/348

    27.8.2020

    25.8.2020

    Shingrix

    GlaxoSmithKline Biologicals S.A.

    rue de l'Institut 89, 1330 Rixensart, Belgique

    EU/1/18/1272

    26.8.2020

    25.8.2020

    Vemlidy

    Gilead Sciences Ireland UC

    Carrigtohill, County Cork, T45 DP77, Ireland

    EU/1/16/1154

    26.8.2020

    25.8.2020

    VITRAKVI

    Bayer AG

    D-51368 Leverkusen, Deutschland

    EU/1/19/1385

    26.8.2020

    25.8.2020

    Votubia

    Novartis Europharm Limited

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

    EU/1/11/710

    25.8.2020

    27.8.2020

    Atriance

    Novartis Europharm Limited

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

    EU/1/07/403

    27.8.2020

    27.8.2020

    Betaferon

    Bayer AG

    D-51368 Leverkusen, Deutschland

    EU/1/95/003

    28.8.2020

    27.8.2020

    Fortacin

    Recordati Ireland Ltd

    Raheens East, Ringaskiddy Co. Cork, Ireland

    EU/1/13/881

    3.9.2020

    27.8.2020

    Imatinib Actavis

    Actavis Group PTC ehf.

    Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

    EU/1/13/825

    28.8.2020

    27.8.2020

    Imfinzi

    AstraZeneca AB

    151 85 Södertälje, Sverige

    EU/1/18/1322

    31.8.2020

    27.8.2020

    NovoThirteen

    Novo Nordisk A/S

    Novo Allé, 2880 Bagsvaerd, Danmark

    EU/1/12/775

    28.8.2020

    27.8.2020

    Skyrizi

    AbbVie Deutschland GmbH & Co. KG

    Knollstrasse, 67061 Ludwigshafen, Deutschland

    EU/1/19/1361

    28.8.2020

    28.8.2020

    Actraphane

    Novo Nordisk A/S

    Novo Allé, 2880 Bagsvaerd, Danmark

    EU/1/02/229

    31.8.2020

    28.8.2020

    Actrapid

    Novo Nordisk A/S

    Novo Allé, 2880 Bagsvaerd, Danmark

    EU/1/02/230

    31.8.2020

    28.8.2020

    Eurartesim

    Alfasigma S.p.A.

    Via Ragazzi del '99, n.5, 40133 Bologna, Italia

    EU/1/11/716

    31.8.2020

    28.8.2020

    IMBRUVICA

    Janssen-Cilag International NV

    Turnhoutseweg 30, 2340 Beerse, België

    EU/1/14/945

    2.9.2020

    28.8.2020

    Olanzapine Mylan

    Mylan S.A.S.

    117 allée des Parcs, 69800 Saint Priest, France

    EU/1/08/475

    31.8.2020

    28.8.2020

    PREZISTA

    Janssen-Cilag International NV

    Turnhoutseweg 30, 2340 Beerse, België

    EU/1/06/380

    1.9.2020

    28.8.2020

    Reyataz

    Bristol-Myers Squibb Pharma EEIG

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

    EU/1/03/267

    31.8.2020

    28.8.2020

    Vyxeos liposomal

    Jazz Pharmaceuticals Ireland Ltd

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

    EU/1/18/1308

    31.8.2020

    28.8.2020

    Xarelto

    Bayer AG

    D-51368 Leverkusen, Deutschland

    EU/1/08/472

    31.8.2020

    —   Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

    Datum sprejetja sklepa

    Ime zdravila

    Imetnik dovoljenja za promet

    Registracijska številka v registru Skupnosti

    Datum obvestila

    14.8.2020

    Qtrilmet

    AstraZeneca AB

    151 85 Södertälje, Sverige

    EU/1/19/1401

    17.8.2020

    —   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

    Datum sprejetja sklepa

    Ime zdravila

    Imetnik dovoljenja za promet

    Registracijska številka v registru Skupnosti

    Datum obvestila

    5.8.2020

    Econor

    Elanco GmbH

    Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

    EU/2/98/010

    6.8.2020

    5.8.2020

    Halocur

    Intervet International B.V.

    Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

    EU/2/99/013

    10.8.2020

    12.8.2020

    ECOPORC SHIGA

    Ceva Santé Animale

    10 avenue de La Ballastière, 33500 Libourne, France

    EU/2/13/149

    14.8.2020

    12.8.2020

    Nobilis IB Primo QX

    Intervet International B.V.

    Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

    EU/2/14/174

    14.8.2020

    12.8.2020

    Respiporc Flu3

    Ceva Santé Animale

    10 avenue de La Ballastière, 33500 Libourne, France

    EU/2/09/103

    31.8.2020

    12.8.2020

    RESPIPORC FLUpan H1N1

    Ceva Santé Animale

    10 avenue de La Ballastière, 33500 Libourne, France

    EU/2/17/209

    31.8.2020

    12.8.2020

    Simparica

    Zoetis Belgium S.A.

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

    EU/2/15/191

    17.8.2020

    18.8.2020

    Suvaxyn PRRS MLV

    Zoetis Belgium S.A.

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

    EU/2/17/215

    21.8.2020

    20.8.2020

    BLUEVAC BTV

    CZ Veterinaria, S.A.

    La Relva s/n – Torneiros, 36410 Porriño, España

    EU/2/11/122

    26.8.2020

    20.8.2020

    Zycortal

    Dechra Regulatory B.V.

    Handelsweg 25, 5531 AE Bladel, Nederland

    EU/2/15/189

    26.8.2020

    28.8.2020

    VEPURED

    Laboratorios Hipra, S.A.

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

    EU/2/17/214

    1.9.2020

    Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:

    European Medicines Agency

    Domenico Scarlattilaan 6

    1083 HS Amsterdam

    NETHERLANDS

    (1)  UL L 136, 30.4.04, str. 1.

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