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30.10.2019 |
EN |
Official Journal of the European Union |
C 369/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 2019
(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 369/01)
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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 |
|
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 |
|
19.9.2019 |
Epidyolex |
cannabidiol |
GW Pharma (International) B.V. Amersfoort A1, Databankweg 26, 3821AL Amersfoort, Nederland |
EU/1/19/1389 |
Oral solution |
N03AX24 |
23.9.2019 |
|
19.9.2019 |
Inbrija |
levodopa |
Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland |
EU/1/19/1390 |
Inhalation powder, hard capsule |
N04BA01 |
23.9.2019 |
|
19.9.2019 |
VITRAKVI |
larotrectinib |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/19/1385 |
Capsule, hard Oral solution |
L01XE53 |
23.9.2019 |
|
26.9.2019 |
Deferasirox Mylan |
deferasirox |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/19/1386 |
Film-coated tablet |
V03AC03 |
30.9.2019 |
|
26.9.2019 |
Trogarzo |
ibalizumab |
Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland |
EU/1/19/1359 |
Concentrate for solution for infusion |
J05AX23 |
30.9.2019 |
|
27.9.2019 |
NUCEIVA |
botulinum toxin type A |
Evolus Pharma Limited 70 Sir John Rogerson's Quay, Dublin 2, Ireland |
EU/1/19/1364 |
Powder for solution for injection |
M03AX01 |
1.10.2019 |
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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 |
|
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 |
|
3.9.2019 |
AMGLIDIA |
AMMTeK 55 rue de Turbigo, 75003 Paris, France |
EU/1/18/1279 |
5.9.2019 |
|
3.9.2019 |
Clopidogrel Zentiva |
Zentiva, k.s. U Kabelovny 130, 10 237 Praha 10, Česká republika |
EU/1/08/465 |
5.9.2019 |
|
3.9.2019 |
Cosentyx |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/14/980 |
5.9.2019 |
|
3.9.2019 |
DuoPlavin |
Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France |
EU/1/10/619 |
5.9.2019 |
|
3.9.2019 |
Emtricitabine/Tenofovir disoproxil Zentiva |
Zentiva, k.s. U Kabelovny 130, 10 237 Praha 10, Česká republika |
EU/1/16/1148 |
5.9.2019 |
|
3.9.2019 |
GILENYA |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/11/677 |
5.9.2019 |
|
3.9.2019 |
Lonsurf |
Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France |
EU/1/16/1096 |
5.9.2019 |
|
3.9.2019 |
Lucentis |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/374 |
5.9.2019 |
|
3.9.2019 |
Pramipexole Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/08/490 |
5.9.2019 |
|
3.9.2019 |
Stelara |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/08/494 |
5.9.2019 |
|
3.9.2019 |
Suliqua |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/16/1157 |
5.9.2019 |
|
3.9.2019 |
Sylvant |
EUSA Pharma (Netherlands) B.V. Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland |
EU/1/14/928 |
5.9.2019 |
|
3.9.2019 |
Tecentriq |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/17/1220 |
5.9.2019 |
|
6.9.2019 |
IMBRUVICA |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/945 |
10.9.2019 |
|
6.9.2019 |
Pylobactell |
Torbet Laboratories Ireland Limited 20 Holles Street, Dublin 2, Ireland |
EU/1/98/064 |
10.9.2019 |
|
6.9.2019 |
Rasagiline ratiopharm |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/14/977 |
10.9.2019 |
|
9.9.2019 |
Fexeric |
Akebia Europe Limited c/o Matheson, 70 Sir John Rogerson’s Quay, Dublin 2, Ireland |
EU/1/15/1039 |
11.9.2019 |
|
9.9.2019 |
Kovaltry |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/15/1076 |
11.9.2019 |
|
13.9.2019 |
Atripla |
Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland |
EU/1/07/430 |
17.9.2019 |
|
13.9.2019 |
Kyntheum |
Leo Pharma A/S Industriparken 55, 2750 Ballerup, Danmark |
EU/1/16/1155 |
17.9.2019 |
|
13.9.2019 |
Levetiracetam Actavis Group |
Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland |
EU/1/11/738 |
17.9.2019 |
|
13.9.2019 |
Opatanol |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/02/217 |
17.9.2019 |
|
13.9.2019 |
Prepandrix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/08/453 |
17.9.2019 |
|
13.9.2019 |
Rapamune |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/01/171 |
17.9.2019 |
|
13.9.2019 |
Sivextro |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/991 |
17.9.2019 |
|
13.9.2019 |
Twinrix Adult |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/96/020 |
17.9.2019 |
|
13.9.2019 |
Twinrix Paediatric |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/97/029 |
17.9.2019 |
|
16.9.2019 |
Champix |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/06/360 |
18.9.2019 |
|
16.9.2019 |
Cosentyx |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/14/980 |
18.9.2019 |
|
16.9.2019 |
Elonva |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/09/609 |
18.9.2019 |
|
16.9.2019 |
Fertavid |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/09/510 |
18.9.2019 |
|
16.9.2019 |
Inflectra |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/13/854 |
18.9.2019 |
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16.9.2019 |
Laventair Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/899 |
18.9.2019 |
|
16.9.2019 |
Lymphoseek |
Norgine B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland |
EU/1/14/955 |
18.9.2019 |
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16.9.2019 |
Mepsevii |
Ultragenyx Germany GmbH Friedrichstraße 191, 10117 Berlin, Deutschland |
EU/1/18/1301 |
18.9.2019 |
|
16.9.2019 |
Ninlaro |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/16/1094 |
18.9.2019 |
|
16.9.2019 |
Nivestim |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/10/631 |
18.9.2019 |
|
16.9.2019 |
Olumiant |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/16/1170 |
18.9.2019 |
|
16.9.2019 |
Pregabalin Zentiva |
Zentiva, k.s. U Kabelovny 130, 10 237 Praha 10, Česká republika |
EU/1/15/1021 |
18.9.2019 |
|
16.9.2019 |
Remsima |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |
EU/1/13/853 |
18.9.2019 |
|
16.9.2019 |
Riximyo |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/17/1184 |
18.9.2019 |
|
16.9.2019 |
Somavert |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/02/240 |
18.9.2019 |
|
16.9.2019 |
Stelara |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/08/494 |
18.9.2019 |
|
16.9.2019 |
Tenofovir disoproxil Zentiva |
Zentiva, k.s. U Kabelovny 130, 10 237 Praha 10, Česká republika |
EU/1/16/1127 |
18.9.2019 |
|
19.9.2019 |
ADCETRIS |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/12/794 |
23.9.2019 |
|
19.9.2019 |
Anoro Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/898 |
23.9.2019 |
|
19.9.2019 |
Ganfort |
Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland |
EU/1/06/340 |
23.9.2019 |
|
19.9.2019 |
Lumark |
IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland |
EU/1/15/1013 |
23.9.2019 |
|
19.9.2019 |
Lysodren |
HRA Pharma Rare Diseases 200 avenue de Paris, 92 320 Chatillon, France |
EU/1/04/273 |
23.9.2019 |
|
19.9.2019 |
Multaq |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/09/591 |
23.9.2019 |
|
19.9.2019 |
Tegsedi |
Akcea Therapeutics Ireland Ltd Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland |
EU/1/18/1296 |
23.9.2019 |
|
19.9.2019 |
Tyverb |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/440 |
23.9.2019 |
|
19.9.2019 |
Viekirax |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/14/982 |
23.9.2019 |
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19.9.2019 |
Xadago |
Zambon S.p.A. Via Lillo del Duca 10, 20 091 Bresso (MI), Italia |
EU/1/14/984 |
23.9.2019 |
|
23.9.2019 |
APTIVUS |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/05/315 |
25.9.2019 |
|
23.9.2019 |
BYDUREON |
AstraZeneca AB 15 185 Södertälje, Sverige |
EU/1/11/696 |
25.9.2019 |
|
23.9.2019 |
Caelyx |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/96/011 |
25.10.2019 |
|
23.9.2019 |
Ciambra |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/15/1055 |
25.9.2019 |
|
23.9.2019 |
EndolucinBeta |
ITG Isotope Technologies Garching GmbH Lichtenbergstraße 1, 85748 Garching, Deutschland |
EU/1/16/1105 |
25.9.2019 |
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23.9.2019 |
Epclusa |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/16/1116 |
25.9.2019 |
|
23.9.2019 |
Hyrimoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/18/1286 |
25.9.2019 |
|
23.9.2019 |
Incruse Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/922 |
25.9.2019 |
|
23.9.2019 |
Moventig |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/14/962 |
25.9.2019 |
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23.9.2019 |
Myalepta |
Aegerion Pharmaceuticals B.V. Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland |
EU/1/18/1276 |
25.9.2019 |
|
23.9.2019 |
Ofev |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/979 |
25.9.2019 |
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23.9.2019 |
Parsabiv |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/16/1142 |
25.9.2019 |
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23.9.2019 |
Rixathon |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/17/1185 |
25.9.2019 |
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23.9.2019 |
Saxenda |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/15/992 |
25.9.2019 |
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23.9.2019 |
Thyrogen |
Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |
EU/1/99/122 |
25.9.2019 |
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23.9.2019 |
Tolura |
Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/10/632 |
25.9.2019 |
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23.9.2019 |
Vectibix |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/07/423 |
25.9.2019 |
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26.9.2019 |
Cyramza |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/14/957 |
30.9.2019 |
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26.9.2019 |
Exviera |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/14/983 |
30.9.2019 |
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26.9.2019 |
OPDIVO |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/15/1014 |
30.9.2019 |
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26.9.2019 |
Rolufta Ellipta |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/17/1174 |
30.9.2019 |
|
26.9.2019 |
Vosevi |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/17/1223 |
30.9.2019 |
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— |
Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
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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 |
|
3.9.2019 |
Iblias |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/15/1077 |
5.9.2019 |
|
— |
Issuing of a marketing authorization (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 |
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 |
|
17.9.2019 |
Simparica Trio |
sarolaner / moxidectin / pyrantel embonate |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/19/243 |
Chewable tablet |
QP54AB52 |
19.9.2019 |
|
— |
Modification of a marketing authorization (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 authorization |
Number of the entry in the Community Register |
Date of notification |
|
6.9.2019 |
RESPIPORC FLUpan H1N1 |
IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Rosslau, Deutschland |
EU/2/17/209 |
10.9.2019 |
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13.9.2019 |
Porcilis PCV M Hyo |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/14/175 |
17.9.2019 |
|
20.9.2019 |
Cepedex |
CP-Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf, Deutschland |
EU/2/16/200 |
24.9.2019 |
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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The Netherlands |