This document is an excerpt from the EUR-Lex website
Document 52018XC1130(02)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2018 to 31 October 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. spalio 1 d. iki 2018 m. spalio 31 d. (Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)
Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. spalio 1 d. iki 2018 m. spalio 31 d. (Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)
OL C 433, 2018 11 30, p. 6–11
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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30.11.2018 |
LT |
Europos Sąjungos oficialusis leidinys |
C 433/6 |
Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. spalio 1 d. iki 2018 m. spalio 31 d.
(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį)
(2018/C 433/02)
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— |
Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): priimta |
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Sprendimo data |
Vaisto pavadinimas |
INN (Tarptautinis nepatentuotas pavadinimas) |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Farmacinė forma |
ATC kodas (Anatominis terapinis cheminis kodas) |
Pranešimo data |
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2018 10 31 |
Symkevi |
Tezakaftoras / ivakaftoras |
Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom |
ES/1/18/1306 |
Plėvele dengta tabletė |
R07AX31 |
2018 11 6 |
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— |
Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): priimta |
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Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
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2018 10 4 |
Exviera |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
ES/1/14/983 |
2018 10 8 |
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2018 10 4 |
Grastofil |
Apotex Europe B.V. Archimedesweg 2, 2333 CN Leiden, Nederland |
ES/1/13/877 |
2018 10 8 |
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2018 10 4 |
Palonosetron Hospira |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
ES/1/16/1100 |
2018 10 8 |
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2018 10 10 |
Irbesartan Zentiva |
Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika |
ES/1/06/376 |
2018 10 12 |
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2018 10 10 |
Kalydeco |
Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom |
ES/1/12/782 |
2018 10 12 |
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2018 10 11 |
Riximyo |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
ES/1/17/1184 |
2018 10 15 |
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2018 10 16 |
ABILIFY MAINTENA |
Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland |
ES/1/13/882 |
2018 10 18 |
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2018 10 16 |
Kivexa |
ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |
ES/1/04/298 |
2018 10 18 |
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2018 10 16 |
Leflunomide Zentiva |
Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika |
ES/1/09/604 |
2018 10 18 |
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2018 10 16 |
Rapamune |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
ES/1/01/171 |
2018 10 18 |
|
2018 10 16 |
Sutent |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
ES/1/06/347 |
2018 10 18 |
|
2018 10 18 |
Evoltra |
Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland |
ES/1/06/334 |
2018 10 22 |
|
2018 10 18 |
Forsteo |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
ES/1/03/247 |
2018 10 22 |
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2018 10 18 |
Irbesartan/Hydrochlorothiazide Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
ES/1/09/583 |
2018 10 22 |
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2018 10 18 |
Pemetrexed Hospira |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
ES/1/15/1057 |
2018 10 22 |
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2018 10 18 |
Velphoro |
Vifor Fresenius Medical Care Renal Pharma France 100–101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France |
ES/1/14/943 |
2018 10 22 |
|
2018 10 23 |
Cosentyx |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
ES/1/14/980 |
2018 10 25 |
|
2018 10 23 |
Micardis |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
ES/1/98/090 |
2018 10 25 |
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2018 10 23 |
XALKORI |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
ES/1/12/793 |
2018 10 25 |
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2018 10 23 |
Xtandi |
Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland |
ES/1/13/846 |
2018 10 25 |
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2018 10 23 |
Zinbryta |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
ES/1/16/1107 |
2018 10 25 |
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2018 10 25 |
Clopidogrel/Acetylsalicylic acid Zentiva |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
ES/1/10/623 |
2018 10 29 |
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2018 10 25 |
Clopidogrel Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
ES/1/08/465 |
2018 10 29 |
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2018 10 25 |
Cyltezo |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
ES/1/17/1240 |
2018 10 29 |
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2018 10 25 |
DuoPlavin |
Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France |
ES/1/10/619 |
2018 10 29 |
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2018 10 25 |
Iscover |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
ES/1/98/070 |
2018 10 29 |
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2018 10 25 |
Plavix |
Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France |
ES/1/98/069 |
2018 10 29 |
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2018 10 25 |
Replagal |
Shire Human Genetic Therapies AB Vasagatan 7, 111 20 Stockholm, Sverige |
ES/1/01/189 |
2018 10 29 |
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2018 10 25 |
Sustiva |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
ES/1/99/110 |
2018 10 29 |
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2018 10 25 |
Synflorix |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
ES/1/09/508 |
2018 10 29 |
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2018 10 29 |
AMGEVITA |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
ES/1/16/1164 |
2018 10 31 |
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2018 10 29 |
Evista |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland |
ES/1/98/073 |
2018 10 31 |
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2018 10 29 |
Imraldi |
Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland |
ES/1/17/1216 |
2018 10 31 |
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2018 10 29 |
Integrilin |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
ES/1/99/109 |
2018 10 31 |
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2018 10 29 |
Protopic |
Leo Pharma A/S Industriparken 55, 2750 Ballerup, Danmark |
ES/1/02/201 |
2018 11 1 |
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2018 10 29 |
RoActemra |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
ES/1/08/492 |
2018 10 31 |
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2018 10 29 |
Taxespira |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom |
ES/1/15/1017 |
2018 10 31 |
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2018 10 29 |
Venclyxto |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
ES/1/16/1138 |
2018 10 31 |
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2018 10 29 |
Volibris |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
ES/1/08/451 |
2018 10 31 |
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2018 10 31 |
Arzerra |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
ES/1/10/625 |
2018 11 6 |
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2018 10 31 |
Elebrato Ellipta |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
ES/1/17/1237 |
2018 11 6 |
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2018 10 31 |
Neulasta |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
ES/1/02/227 |
2018 11 6 |
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2018 10 31 |
Samsca |
Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland |
ES/1/09/539 |
2018 11 6 |
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2018 10 31 |
Trelegy Ellipta |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
ES/1/17/1236 |
2018 11 6 |
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— |
Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis) |
|
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
|
2018 10 29 |
Lusduna |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
ES/1/16/1162 |
2018 10 31 |
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2018 10 30 |
Taxespira |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom |
ES/1/15/1017 |
2018 11 1 |
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— |
Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): priimta |
|
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
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2018 10 17 |
Recocam |
Bimeda Animal Health Limited 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland |
ES/2/11/133 |
2018 10 19 |
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2018 10 18 |
NexGard |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
ES/2/13/159 |
2018 10 22 |
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2018 10 18 |
NEXGARD SPECTRA |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
ES/2/14/177 |
2018 10 22 |
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2018 10 23 |
Canigen L4 |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
ES/2/15/183 |
2018 10 25 |
|
2018 10 30 |
Dexdomitor |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
ES/2/02/033 |
2018 11 1 |
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2018 10 30 |
Improvac |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
ES/2/09/095 |
2018 11 5 |
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2018 10 30 |
Zolvix |
Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |
ES/2/09/101 |
2018 11 1 |
Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:
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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 |