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Document C:2019:032:FULL
Official Journal of the European Union, C 32, 25 January 2019
Official Journal of the European Union, C 32, 25 January 2019
Official Journal of the European Union, C 32, 25 January 2019
Display all documents published in this Official Journal
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ISSN 1977-091X |
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Official Journal of the European Union |
C 32 |
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English edition |
Information and Notices |
Volume 62 |
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Contents |
page |
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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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2019/C 32/01 |
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2019/C 32/02 |
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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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25.1.2019 |
EN |
Official Journal of the European Union |
C 32/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2018 to 31 December 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2019/C 32/01)
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— |
Issuing of a marketing authorization (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 authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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12.12.2018 |
Dengvaxia |
dengue tetravalent vaccine (live, attenuated) |
Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France |
EU/1/18/1338 |
Powder and solvent for suspension for injection |
J07BX |
14.12.2018 |
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12.12.2018 |
Flucelvax Tetra |
influenza vaccine (surface antigen, inactivated, prepared in cell cultures) |
Seqirus Netherlands B.V. Hullenbergweg 89 1101 CL Amsterdam, Nederland |
EU/1/18/1326 |
Suspension for injection |
J07BB02 |
14.12.2018 |
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12.12.2018 |
Ogivri |
trastuzumab |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/18/1341 |
Powder for concentrate for solution for infusion |
L01XC03 |
14.12.2018 |
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18.12.2018 |
Bevespi Aerosphere |
glycopyrronium bromide / formoterol |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/18/1339 |
Pressurised inhalation, suspension |
R03AL07 |
20.12.2018 |
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18.12.2018 |
Namuscla |
Mexiletine |
Lupin Europe GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland |
EU/1/18/1325 |
Capsule, hard |
C01BB02 |
20.12.2018 |
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— |
Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected |
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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6.12.2018 |
Exondys |
AVI BioPharma International Ltd Tower Bridge House, St Katharine’s Way, London E1W 1DD, United Kingdom |
— |
10.12.2018 |
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— |
Modification of a marketing authorization (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 |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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6.12.2018 |
Anoro Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/898 |
10.12.2018 |
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6.12.2018 |
Avamys |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/07/434 |
10.12.2018 |
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6.12.2018 |
Darunavir Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/16/1140 |
10.12.2018 |
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7.12.2018 |
Elocta |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige |
EU/1/15/1046 |
12.12.2018 |
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7.12.2018 |
EVOTAZ |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1025 |
12.12.2018 |
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7.12.2018 |
Onivyde |
Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France |
EU/1/16/1130 |
11.12.2018 |
|
7.12.2018 |
Rubraca |
Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland |
EU/1/17/1250 |
11.12.2018 |
|
7.12.2018 |
Tenofovir disoproxil Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/16/1127 |
11.12.2018 |
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7.12.2018 |
Toujeo |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/00/133 |
11.12.2018 |
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7.12.2018 |
Ucedane |
Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland |
EU/1/17/1202 |
11.12.2018 |
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7.12.2018 |
Xermelo |
Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |
EU/1/17/1224 |
11.12.2018 |
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7.12.2018 |
Ziagen |
ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |
EU/1/99/112 |
11.12.2018 |
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10.12.2018 |
Daklinza |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/14/939 |
12.12.2018 |
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10.12.2018 |
Darunavir Krka |
Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/17/1249 |
12.12.2018 |
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10.12.2018 |
Oncaspar |
Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France |
EU/1/15/1070 |
12.12.2018 |
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10.12.2018 |
Xolair |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/05/319 |
12.12.2018 |
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12.12.2018 |
Desloratadine Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/732 |
14.12.2018 |
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12.12.2018 |
Entyvio |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/14/923 |
14.12.2018 |
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12.12.2018 |
Evoltra |
Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |
EU/1/06/334 |
14.12.2018 |
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12.12.2018 |
Kengrexal |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/15/994 |
14.12.2018 |
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12.12.2018 |
Kevzara |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/17/1196 |
14.12.2018 |
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12.12.2018 |
KEYTRUDA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/1024 |
14.12.2018 |
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12.12.2018 |
Mimpara |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/04/292 |
14.12.2018 |
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12.12.2018 |
Moventig |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/14/962 |
14.12.2018 |
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12.12.2018 |
OCALIVA |
Intercept Pharma Ltd 2 Pancras Square, London N1C 4AG, United Kingdom |
EU/1/16/1139 |
17.12.2018 |
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12.12.2018 |
Pandemic influenza vaccine H5N1 BAXTER |
Ology Bioservices Ireland LTD Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland |
EU/1/09/571 |
18.12.2018 |
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12.12.2018 |
Praluent |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/15/1031 |
14.12.2018 |
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12.12.2018 |
Pregabalin Pfizer |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/14/916 |
14.12.2018 |
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12.12.2018 |
Reagila |
Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország |
EU/1/17/1209 |
14.12.2018 |
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12.12.2018 |
Relvar Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/13/886 |
14.12.2018 |
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12.12.2018 |
Revinty Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/929 |
14.12.2018 |
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12.12.2018 |
RXULTI |
Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland |
EU/1/18/1294 |
14.12.2018 |
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12.12.2018 |
Trevicta |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/971 |
14.12.2018 |
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12.12.2018 |
Triumeq |
ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |
EU/1/14/940 |
14.12.2018 |
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12.12.2018 |
Valdoxan |
Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France |
EU/1/08/499 |
14.12.2018 |
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12.12.2018 |
Vfend |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/02/212 |
14.12.2018 |
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17.12.2018 |
Dupixent |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/17/1229 |
19.12.2018 |
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17.12.2018 |
Elaprase |
Shire Human Genetic Therapies AB Vasagatan 7, 111 20 Stockholm, Sverige |
EU/1/06/365 |
19.12.2018 |
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17.12.2018 |
Emtricitabine/Tenofovir disoproxil Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/16/1133 |
19.12.2018 |
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17.12.2018 |
Epivir |
ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |
EU/1/96/015 |
19.12.2018 |
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17.12.2018 |
Hexacima |
Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France |
EU/1/13/828 |
19.12.2018 |
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17.12.2018 |
Hexyon |
Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France |
EU/1/13/829 |
19.12.2018 |
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17.12.2018 |
Kisqali |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/17/1221 |
19.12.2018 |
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17.12.2018 |
Zejula |
TESARO Bio Netherlands B.V. Joop Geeskinkweg, 901, 1114AB, Amsterdam-Duisvendrecht, Nederland |
EU/1/17/1235 |
19.12.2018 |
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17.12.2018 |
Zubsolv |
Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland |
EU/1/17/1233 |
19.12.2018 |
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18.12.2018 |
Alimta |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/290 |
19.12.2018 |
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18.12.2018 |
Amyvid |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/12/805 |
20.12.2018 |
|
18.12.2018 |
Darzalex |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/16/1101 |
20.12.2018 |
|
18.12.2018 |
Granupas |
Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland |
EU/1/13/896 |
20.12.2018 |
|
18.12.2018 |
Ledaga |
Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15, Ireland |
EU/1/16/1171 |
20.12.2018 |
|
18.12.2018 |
Mabthera |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/98/067 |
20.12.2018 |
|
18.12.2018 |
Otezla |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/14/981 |
20.12.2018 |
|
18.12.2018 |
Ravicti |
Horizon Pharma Ireland Limited Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland |
EU/1/15/1062 |
20.12.2018 |
|
18.12.2018 |
Vectibix |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/07/423 |
20.12.2018 |
|
18.12.2018 |
Vokanamet |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/918 |
20.12.2018 |
|
20.12.2018 |
Panretin |
Eisai GmbH Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland |
EU/1/00/149 |
2.1.2019 |
|
20.12.2018 |
Vihuma |
Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige |
EU/1/16/1168 |
27.12.2018 |
|
— |
Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
|
6.12.2018 |
Ivabradine JensonR |
JensonR+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom |
EU/1/16/1145 |
10.12.2018 |
|
17.12.2018 |
Macugen |
PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c, 17000 Praha 7 Česká republika |
EU/1/05/325 |
19.12.2018 |
|
— |
Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
|
12.12.2018 |
LONGRANGE |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
— |
14.12.2018 |
|
— |
Modification of a marketing authorization (Article 38 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 |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
|
7.12.2018 |
Aivlosin |
ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom |
EU/2/04/044 |
11.12.2018 |
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7.12.2018 |
Imrestor |
Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |
EU/2/15/193 |
11.12.2018 |
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12.12.2018 |
Aftovaxpur Doe |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
EU/2/13/153 |
14.12.2018 |
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17.12.2018 |
Bovela |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/14/176 |
19.12.2018 |
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17.12.2018 |
Coxevac |
Ceva Santé Animale 10 avenue de la Ballastière, 33500 Libourne, France |
EU/2/10/110 |
20.12.2018 |
|
17.12.2018 |
Ingelvac CircoFLEX |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/07/079 |
19.12.2018 |
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17.12.2018 |
Nobilis IB 4-91 |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/98/006 |
19.12.2018 |
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18.12.2018 |
Nobilis IB Primo QX |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/14/174 |
20.12.2018 |
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19.12.2018 |
NexGard |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
EU/2/13/159 |
21.12.2018 |
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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30 Churchill Place |
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Canary Wharf |
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London E14 5EU |
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United Kingdom |
|
25.1.2019 |
EN |
Official Journal of the European Union |
C 32/8 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2018 to 31 December 2018
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2019/C 32/02)
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— |
Issuing, maintenance or modification of a national marketing authorization |
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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 |
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18.12.2018 |
Perlinring and associated names - |
etonogestrel/ethinylestradiol |
See annex |
See annex |
19.12.2018 |
ANNEX
List of medicinal products and presentations
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Member State EU/EEA |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
|
Austria |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 0,120 mg/0,015 mg pro 24 Stunden — Vaginalring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Belgium |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 0,120 mg/0,015 mg par 24 heures, système de diffusion vaginal / Perlinring 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Croatia |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 0,120 mg/0,015 mg tijekom 24 sata, sustav za isporuku u rodnicu |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Czech Republic |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Denmark |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Estonia |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Finland |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 0,120 mg/0,015 mg per 24 h depotlääkevalmiste, emättimeen |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
France |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 15 microgrammes/120 microgrammes/24 heures, système de diffusion vaginal |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Germany |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Hungary |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 0,120 mg/0,015 mg/24 óra hüvelyben alkalmazott gyógyszerleadó rendszer |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Iceland |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Ireland |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Italy |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Latvia |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 120/15 mikrogramu 24 stundās vaginālās ievadīšanas sistēma |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Lithuania |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Ongavia 120/15 mikrogramų/24 valandas vartojimo į makštį sistema |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
The Netherlands |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Norway |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Poland |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Portugal |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Romania |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 0,120 mg/0,015 mg/24 ore sistem cu cedare vaginalã |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Slovak Republic |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Slovenia |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Etonogestrel/etinilestradiol Actavis 0,120 mg/0,015 mg na 24 ur vaginalni dostavni sistem |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Spain |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Pirlinring 0,120 mg/0,015 mg for cada 24 horas, sistema de liberación vaginal |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
Sweden |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |
|
United Kingdom |
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur, Iceland |
Perlinring 0,015 mg/0,12 mg/ 24 hours Vaginal Delivery System |
0,120 mg/0,015 mg per 24 hours |
Vaginal Delivery System |
Vaginal use |