# Službeni list C 135/24.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 135 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 63.24. travnja 2020. |

ISSN 1977-1088

Službeni list

Europske unije

C 135

Hrvatsko izdanje

Informacije i objave

Godište 63.24. travnja 2020.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2020/C 135/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2020. do 31. ožujka 2020.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2020/C 135/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2020. do 31. ožujka 2020.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 8 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2020/C 135/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2020. do 31. ožujka 2020.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

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

1

2020/C 135/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2020. do 31. ožujka 2020.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

8

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| HR | |
| --- | --- |

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 24.4.2020 | HR | Službeni list Europske unije | C 135/1 |
| --- | --- | --- | --- |

24.4.2020

HR

Službeni list Europske unije

C 135/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2020. do 31. ožujka 2020.

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

(2020/C 135/01)

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

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.3.2020. | Givlaari | givosiran | Alnylam Netherlands B.V.
  Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland | EU/1/20/1428 | Otopina za injekciju | Pending | 4.3.2020. |
| 24.3.2020. | Azacitidine Betapharm | Azacitidin | betapharm Arzneimittel GmbH
  Kobelweg 95, 86156 Augsburg, Deutschland | EU/1/19/1416 | prašak za suspenziju za injekciju | L01BC07 | 25.3.2020. |
| 24.3.2020. | Liumjev | inzulina lispro | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/20/1422 | Otopina za injekciju | A10AB04 | 26.3.2020. |
| 27.3.2020. | Azacitidine Mylan | Azacitidin | Mylan Ireland Limited
  Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | EU/1/20/1426 | prašak za suspenziju za injekciju | L01BC07 | 30.3.2020. |
| 27.3.2020. | NUBEQA | darolutamid | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/20/1432 | Filmom obložena tableta | L02BB06 | 30.3.2020. |
| 27.3.2020. | Nustendi | bempedoična kiselina/ezetimib | FGK Representative Service GmbH
  Heimeranstraße 35, 80339 München, Deutschland | EU/1/20/1424 | Filmom obložena tableta | Pending | 31.3.2020. |
| 27.3.2020. | Staquis | krisaborol | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/19/1421 | Mast | D11AH06 | 1.4.2020. |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

2.3.2020.

Givlaari

givosiran

Alnylam Netherlands B.V.

Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland

EU/1/20/1428

Otopina za injekciju

Pending

4.3.2020.

24.3.2020.

Azacitidine Betapharm

Azacitidin

betapharm Arzneimittel GmbH

Kobelweg 95, 86156 Augsburg, Deutschland

EU/1/19/1416

prašak za suspenziju za injekciju

L01BC07

25.3.2020.

24.3.2020.

Liumjev

inzulina lispro

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1422

Otopina za injekciju

A10AB04

26.3.2020.

27.3.2020.

Azacitidine Mylan

Azacitidin

Mylan Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/20/1426

prašak za suspenziju za injekciju

L01BC07

30.3.2020.

27.3.2020.

NUBEQA

darolutamid

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/20/1432

Filmom obložena tableta

L02BB06

30.3.2020.

27.3.2020.

Nustendi

bempedoična kiselina/ezetimib

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/20/1424

Filmom obložena tableta

Pending

31.3.2020.

27.3.2020.

Staquis

krisaborol

Pfizer Europe MA EEIG

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

EU/1/19/1421

Mast

D11AH06

1.4.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 3.3.2020. | Mabthera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/98/067 | 5.3.2020. |
| 3.3.2020. | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 5.3.2020. |
| 9.3.2020. | Alkindi | Diurnal Europe B.V.
  Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland | EU/1/17/1260 | 11.3.2020. |
| 9.3.2020. | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, 51377 Leverkusen, Deutschland | EU/1/11/740 | 11.3.2020. |
| 9.3.2020. | BiResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/921 | 11.3.2020. |
| 9.3.2020. | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 11.3.2020. |
| 9.3.2020. | Duloxetine Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1028 | 11.3.2020. |
| 9.3.2020. | DuoResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/920 | 11.3.2020. |
| 9.3.2020. | Fortacin | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/13/881 | 11.3.2020. |
| 9.3.2020. | IKERVIS | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/15/990 | 11.3.2020. |
| 9.3.2020. | Imvanex | Bavarian Nordic A/S
  Hejreskovvej 10a, 3490 Kvistgaard, Danmark | EU/1/13/855 | 11.3.2020. |
| 9.3.2020. | Integrilin | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/99/109 | 11.3.2020. |
| 9.3.2020. | Iressa | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/09/526 | 11.3.2020. |
| 9.3.2020. | Kineret | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/02/203 | 11.3.2020. |
| 9.3.2020. | Lojuxta | Amryt Pharmaceuticals DAC
  90 Harcourt Street, Dublin 2, Ireland | EU/1/13/851 | 11.3.2020. |
| 9.3.2020. | Luxturna | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1331 | 11.3.2020. |
| 9.3.2020. | Nyxoid | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | EU/1/17/1238 | 11.3.2020. |
| 9.3.2020. | Oncaspar | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/15/1070 | 11.3.2020. |
| 9.3.2020. | Onpattro | Alnylam Netherlands B.V.
  Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland | EU/1/18/1320 | 11.3.2020. |
| 9.3.2020. | Ozurdex | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/10/638 | 11.3.2020. |
| 9.3.2020. | Pelmeg | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | EU/1/18/1328 | 11.3.2020. |
| 9.3.2020. | Pregabalin Pfizer | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/14/916 | 11.3.2020. |
| 9.3.2020. | Qtern | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1108 | 11.3.2020. |
| 9.3.2020. | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 11.3.2020. |
| 9.3.2020. | Ristaben | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/10/621 | 18.3.2020. |
| 9.3.2020. | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/12/815 | 11.3.2020. |
| 9.3.2020. | Suliqua | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Pariz, France | EU/1/16/1157 | 11.3.2020. |
| 9.3.2020. | TAKHZYRO | Shire Pharmaceuticals Ireland Limited
  Blocks 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland | EU/1/18/1340 | 11.3.2020. |
| 9.3.2020. | Terrosa | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/16/1159 | 11.3.2020. |
| 9.3.2020. | Tesavel | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/435 | 11.3.2020. |
| 9.3.2020. | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 11.3.2020. |
| 9.3.2020. | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 11.3.2020. |
| 9.3.2020. | Ulunar Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/917 | 11.3.2020. |
| 9.3.2020. | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 11.3.2020. |
| 9.3.2020. | XALKORI | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/793 | 11.3.2020. |
| 9.3.2020. | Xelevia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/382 | 11.3.2020. |
| 9.3.2020. | Xoterna Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/863 | 11.3.2020. |
| 10.3.2020. | Epivir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/96/015 | 12.3.2020. |
| 10.3.2020. | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, 1030 Wien, Österreich | EU/1/08/501 | 12.3.2020. |
| 10.3.2020. | Pemetrexed Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1037 | 12.3.2020. |
| 10.3.2020. | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Luxembourg | EU/1/08/462 | 12.3.2020. |
| 16.3.2020. | Akynzeo | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/15/1001 | 18.3.2020. |
| 16.3.2020. | Olazax Disperzi | Glenmark Pharmaceuticals s.r.o.
  Hvězdova 1716/2b, 14078 Praha 4, Česká republika | EU/1/09/592 | 18.3.2020. |
| 16.3.2020. | Pandemic influenza vaccine H5N1 AstraZeneca | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1089 | 18.3.2020. |
| 16.3.2020. | Waylivra | Akcea Therapeutics Ireland Limited
  Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland | EU/1/19/1360 | 18.3.2020. |
| 24.3.2020. | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/12/792 | 25.3.2020. |
| 24.3.2020. | Epclusa | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1116 | 25.3.2020. |
| 24.3.2020. | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 30.3.2020. |
| 24.3.2020. | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/10/643 | 26.3.2020. |
| 24.3.2020. | Shingrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/18/1272 | 25.3.2020. |
| 24.3.2020. | Vorikonazol Hikma | Hikma Farmacêutica (Portugal), S.A.
  Estrada do Rio da Mó n.o 8, 8 A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal | EU/1/15/1004 | 26.3.2020. |
| 27.3.2020. | Alofisel | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/17/1261 | 6.4.2020. |
| 27.3.2020. | EVOTAZ | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/15/1025 | 6.4.2020. |
| 27.3.2020. | Halimatoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1288 | 5.4.2020. |
| 27.3.2020. | Hefiya | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1287 | 6.4.2020. |
| 27.3.2020. | Hyrimoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1286 | 5.4.2020. |
| 27.3.2020. | Lenalidomide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/18/1316 | 31.3.2020. |
| 27.3.2020. | Ozempic | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/17/1251 | 31.3.2020. |
| 27.3.2020. | SomaKit TOC | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/16/1141 | 6.4.2020. |
| 27.3.2020. | Vaborem | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Luxembourg | EU/1/18/1334 | 30.3.2020. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.3.2020.

Mabthera

Roche Registration GmbH

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

EU/1/98/067

5.3.2020.

3.3.2020.

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

5.3.2020.

9.3.2020.

Alkindi

Diurnal Europe B.V.

Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland

EU/1/17/1260

11.3.2020.

9.3.2020.

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, 51377 Leverkusen, Deutschland

EU/1/11/740

11.3.2020.

9.3.2020.

BiResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

11.3.2020.

9.3.2020.

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

11.3.2020.

9.3.2020.

Duloxetine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1028

11.3.2020.

9.3.2020.

DuoResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

11.3.2020.

9.3.2020.

Fortacin

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/13/881

11.3.2020.

9.3.2020.

IKERVIS

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/15/990

11.3.2020.

9.3.2020.

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, 3490 Kvistgaard, Danmark

EU/1/13/855

11.3.2020.

9.3.2020.

Integrilin

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/109

11.3.2020.

9.3.2020.

Iressa

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/526

11.3.2020.

9.3.2020.

Kineret

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

11.3.2020.

9.3.2020.

Lojuxta

Amryt Pharmaceuticals DAC

90 Harcourt Street, Dublin 2, Ireland

EU/1/13/851

11.3.2020.

9.3.2020.

Luxturna

Novartis Europharm Limited

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

EU/1/18/1331

11.3.2020.

9.3.2020.

Nyxoid

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/17/1238

11.3.2020.

9.3.2020.

Oncaspar

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/15/1070

11.3.2020.

9.3.2020.

Onpattro

Alnylam Netherlands B.V.

Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland

EU/1/18/1320

11.3.2020.

9.3.2020.

Ozurdex

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

11.3.2020.

9.3.2020.

Pelmeg

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/18/1328

11.3.2020.

9.3.2020.

Pregabalin Pfizer

Pfizer Europe MA EEIG

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

EU/1/14/916

11.3.2020.

9.3.2020.

Qtern

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1108

11.3.2020.

9.3.2020.

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

11.3.2020.

9.3.2020.

Ristaben

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/621

18.3.2020.

9.3.2020.

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

11.3.2020.

9.3.2020.

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/16/1157

11.3.2020.

9.3.2020.

TAKHZYRO

Shire Pharmaceuticals Ireland Limited

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

EU/1/18/1340

11.3.2020.

9.3.2020.

Terrosa

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/16/1159

11.3.2020.

9.3.2020.

Tesavel

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/435

11.3.2020.

9.3.2020.

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

11.3.2020.

9.3.2020.

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

11.3.2020.

9.3.2020.

Ulunar Breezhaler

Novartis Europharm Limited

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

EU/1/14/917

11.3.2020.

9.3.2020.

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

11.3.2020.

9.3.2020.

XALKORI

Pfizer Europe MA EEIG

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

EU/1/12/793

11.3.2020.

9.3.2020.

Xelevia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/382

11.3.2020.

9.3.2020.

Xoterna Breezhaler

Novartis Europharm Limited

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

EU/1/13/863

11.3.2020.

10.3.2020.

Epivir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/96/015

12.3.2020.

10.3.2020.

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/08/501

12.3.2020.

10.3.2020.

Pemetrexed Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1037

12.3.2020.

10.3.2020.

Ranexa

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/08/462

12.3.2020.

16.3.2020.

Akynzeo

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/15/1001

18.3.2020.

16.3.2020.

Olazax Disperzi

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b, 14078 Praha 4, Česká republika

EU/1/09/592

18.3.2020.

16.3.2020.

Pandemic influenza vaccine H5N1 AstraZeneca

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

18.3.2020.

16.3.2020.

Waylivra

Akcea Therapeutics Ireland Limited

Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

EU/1/19/1360

18.3.2020.

24.3.2020.

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/12/792

25.3.2020.

24.3.2020.

Epclusa

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

25.3.2020.

24.3.2020.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

30.3.2020.

24.3.2020.

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

26.3.2020.

24.3.2020.

Shingrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

25.3.2020.

24.3.2020.

Vorikonazol Hikma

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8 A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

26.3.2020.

27.3.2020.

Alofisel

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/17/1261

6.4.2020.

27.3.2020.

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1025

6.4.2020.

27.3.2020.

Halimatoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

5.4.2020.

27.3.2020.

Hefiya

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

6.4.2020.

27.3.2020.

Hyrimoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

5.4.2020.

27.3.2020.

Lenalidomide Accord

Accord Healthcare S.L.U.

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

EU/1/18/1316

31.3.2020.

27.3.2020.

Ozempic

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

31.3.2020.

27.3.2020.

SomaKit TOC

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/16/1141

6.4.2020.

27.3.2020.

Vaborem

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/18/1334

30.3.2020.

—   Obustava odobrenja za stavljanje u promet (članak 20. 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 |
| --- | --- | --- | --- | --- |
| 25.3.2020. | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/12/750 | 27.3.2020. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

25.3.2020.

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

27.3.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 4.3.2020. | Rabitec | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/17/219 | 6.3.2020. |
| 4.3.2020. | Respiporc Flu3 | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/09/103 | 6.3.2020. |
| 9.3.2020. | Activyl Tick Plus | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/11/137 | 11.3.2020. |
| 9.3.2020. | Clomicalm | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/98/007 | 11.3.2020. |
| 9.3.2020. | ECOPORC SHIGA | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/13/149 | 11.3.2020. |
| 24.3.2020. | Activyl | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/10/118 | 25.3.2020. |
| 27.3.2020. | CLYNAV | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/16/197 | 31.3.2020. |
| 27.3.2020. | MS-H vaccine | Pharmsure Veterinary Products Europe Ltd
  4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland | EU/2/11/126 | 31.3.2020. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.3.2020.

Rabitec

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/17/219

6.3.2020.

4.3.2020.

Respiporc Flu3

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/09/103

6.3.2020.

9.3.2020.

Activyl Tick Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/137

11.3.2020.

9.3.2020.

Clomicalm

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/98/007

11.3.2020.

9.3.2020.

ECOPORC SHIGA

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/13/149

11.3.2020.

24.3.2020.

Activyl

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/118

25.3.2020.

27.3.2020.

CLYNAV

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/197

31.3.2020.

27.3.2020.

MS-H vaccine

Pharmsure Veterinary Products Europe Ltd

4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland

EU/2/11/126

31.3.2020.

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 |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

---

| 24.4.2020 | HR | Službeni list Europske unije | C 135/8 |
| --- | --- | --- | --- |

24.4.2020

HR

Službeni list Europske unije

C 135/8

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2020. do 31. ožujka 2020.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ (1) ili člankom 38. Direktive 2001/82/EZ (2))

(2020/C 135/02)

—   Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država članica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 4.2.2020. | Ketabel 100 mg/ml | ketamine | Vidjeti Prilog | Vidjeti Prilog | 4.3.2020. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država članica na koju se odnosi

Datum obavijesti

4.2.2020.

Ketabel 100 mg/ml

ketamine

Vidjeti Prilog

Vidjeti Prilog

4.3.2020.

---

(1)  SL L 311, 28.11.2001., str. 67.

(2)  SL L 311, 28.11.2001., str. 1.

---

PRILOG

Popis nazivâ, farmaceutskog oblika, jačine veterinarsko-medicinskih proizvoda, vrsta životinja, putova primjene, podnositelja zahtjeva/nositelja odobrenja za stavljanje u promet u državama članicama

| Država članica EU-a/EGP-a | Podnositelj zahtjeva/nositelj odobrenja za stavljanje VMP-a u promet | Naziv | Međunarodno nezaštićeno ime | Jačina | Farmaceutski oblik | Vrsta životinja | Put primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Belatamin 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Bugarska | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Češka | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Njemačka | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Estonija | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Grčka | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Finska | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel vet. 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Francuska | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Mađarska | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Irska | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Island | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel vet. 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Litva | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Letonija | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Nizozemska | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Norveška | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Belatamin vet. 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Portugal | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Rumunjska | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Švedska | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel vet. 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Slovačka | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Slovenija | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |
| Ujedinjeno Kraljevstvo | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | ketamin | 100 mg/ml | Otopina za injekciju | Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi | Intravenska primjena, intramuskularna, u trbušnu šupljinu |

Država članica EU-a/EGP-a

Podnositelj zahtjeva/nositelj odobrenja za stavljanje VMP-a u promet

Naziv

Međunarodno nezaštićeno ime

Jačina

Farmaceutski oblik

Vrsta životinja

Put primjene

Austrija

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Belatamin 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Bugarska

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Češka

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Njemačka

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Estonija

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Grčka

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Finska

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel vet. 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Francuska

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Mađarska

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Irska

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Island

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel vet. 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Litva

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Letonija

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Nizozemska

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Norveška

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Belatamin vet. 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Portugal

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Rumunjska

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Švedska

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel vet. 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Slovačka

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Slovenija

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

Ujedinjeno Kraljevstvo

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

ketamin

100 mg/ml

Otopina za injekciju

Goveda, svinje, ovce, koze, konji, psi, mačke, zamorci, hrčci, zečevi, štakori i miševi

Intravenska primjena, intramuskularna, u trbušnu šupljinu

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