ISSN 1977-091X
Official Journal
of the European Union
C 135
English edition
Information and Notices
Volume 63
24 April 2020
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ISSN 1977-091X |
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Official Journal of the European Union |
C 135 |
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English edition |
Information and Notices |
Volume 63 |
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Contents |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2020/C 135/01 |
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2020/C 135/02 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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24.4.2020 |
EN |
Official Journal of the European Union |
C 135/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2020 to 31 March 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2020/C 135/01)
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|
2.3.2020 |
Givlaari |
givosiran |
Alnylam Netherlands B.V. Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland |
EU/1/20/1428 |
Solution for injection |
Pending |
4.3.2020 |
|
24.3.2020 |
Azacitidine Betapharm |
Azacitidine |
betapharm Arzneimittel GmbH Kobelweg 95, 86156 Augsburg, Deutschland |
EU/1/19/1416 |
Powder for suspension for injection |
L01BC07 |
25.3.2020 |
|
24.3.2020 |
Liumjev |
Insulin lispro |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/20/1422 |
Solution for injection |
A10AB04 |
26.3.2020 |
|
27.3.2020 |
Azacitidine Mylan |
Azacitidine |
Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |
EU/1/20/1426 |
Powder for suspension for injection |
L01BC07 |
30.3.2020 |
|
27.3.2020 |
NUBEQA |
darolutamide |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/20/1432 |
Film-coated tablet |
L02BB06 |
30.3.2020 |
|
27.3.2020 |
Nustendi |
bempedoic acid/ezetimibe |
FGK Representative Service GmbH Heimeranstraße 35, 80339 München, Deutschland |
EU/1/20/1424 |
Film-coated tablet |
Pending |
31.3.2020 |
|
27.3.2020 |
Staquis |
crisaborole |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/19/1421 |
Ointment |
D11AH06 |
1.4.2020 |
— 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 |
|
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 |
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9.3.2020 |
Qtern |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/16/1108 |
11.3.2020 |
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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 |
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9.3.2020 |
Selincro |
H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark |
EU/1/12/815 |
11.3.2020 |
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9.3.2020 |
Suliqua |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/16/1157 |
11.3.2020 |
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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 |
Voriconazole Hikma |
Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.o 8, 8A 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 |
— Suspension of a marketing authorisation (Article 20 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 |
|
25.3.2020 |
Esmya |
Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország |
EU/1/12/750 |
27.3.2020 |
— 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 |
|
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 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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European Medicines Agency |
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Domenico Scarlattilaan 6 |
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1083 HS Amsterdam |
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NETHERLANDS |
|
24.4.2020 |
EN |
Official Journal of the European Union |
C 135/8 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2020 to 31 March 2020
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2020/C 135/02)
— Issuing, maintenance or modification of a national marketing authorization
|
Date of the decision |
Name(s) of the medicinal product |
INN (International Non-Proprietary Name) |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
4.2.2020 |
Ketabel 100 mg/ml |
ketamine |
See Annex |
See Annex |
4.3.2020 |
ANNEX
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
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Member State EU/EEA |
Applicant |
Name |
INN |
Strength |
Pharmaceutical form |
Animal species |
Route of administration |
|
Austria |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Belatamin 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Bulgaria |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Czechia |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Germany |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Estonia |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Greece |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Finland |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel vet. 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
France |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Hungary |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Ireland |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Iceland |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel vet. 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Lithuania |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Latvia |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
The Netherlands |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Norway |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Belatamin vet. 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Portugal |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Romania |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Sweden |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel vet. 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Slovakia |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
Slovenia |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |
|
United Kingdom |
Bela-Pharm GmbH & Co. KG Lohner Strasse 19 49377 Vechta Germany |
Ketabel 100 mg/ml solution for injection |
Ketamine |
100 mg/ml |
Solution for injection |
Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice |
Intravenous, intramuscular and intraperitoneal use |