ISSN 1977-0960
Europos Sąjungos
oficialusis leidinys
C 61
Leidimas lietuvių kalba
Informacija ir pranešimai
60 metai
2017m. vasario 24d.
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ISSN 1977-0960 |
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Europos Sąjungos oficialusis leidinys |
C 61 |
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Leidimas lietuvių kalba |
Informacija ir pranešimai |
60 metai |
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Pranešimo Nr. |
Turinys |
Puslapis |
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IV Pranešimai |
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EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
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Europos Komisija |
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2017/C 61/01 |
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LT |
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IV Pranešimai
EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI
Europos Komisija
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24.2.2017 |
LT |
Europos Sąjungos oficialusis leidinys |
C 61/1 |
Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. sausio 1 d. iki 2017 m. sausio 31 d.
(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį)
(2017/C 061/01)
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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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2017 1 4 |
AFSTYLA |
alfa lonoktokogs |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/16/1158 |
Milteliai ir tirpiklis injekciniam tirpalui |
B02BD02 |
2017 1 6 |
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2017 1 4 |
Darunavir Mylan |
darunaviras |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/16/1140 |
Plėvele dengta tabletė |
J05AE10 |
2017 1 6 |
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2017 1 4 |
Lusduna |
insulinas glarginas |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/16/1162 |
Injekcinis tirpalas |
A10AE04 |
2017 1 6 |
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2017 1 4 |
Terrosa |
Teriparatida |
Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország |
EU/1/16/1159 |
Injekcinis tirpalas |
H05AA02 |
2017 1 6 |
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2017 1 9 |
Fiasp |
Insulinas aspartas |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Danmark |
EU/1/16/1160 |
Injekcinis tirpalas |
A10AB05 |
2017 1 11 |
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2017 1 9 |
Tadalafil Generics |
tadalafilis |
Mylan S.A.S. 117 Allée des Parcs, 69800 Saint-Priest, France |
EU/1/16/1153 |
Plėvele dengta tabletė |
G04BE08 |
2017 1 11 |
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2017 1 9 |
Vemlidy |
tenofovir alafenamide |
Gilead Sciences International Ltd. Cambridge, CB21 6GT, United Kingdom |
EU/1/16/1154 |
Plėvele dengta tabletė |
J05AF13 |
2017 1 11 |
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2017 1 11 |
Movymia |
Teriparatida |
STADA Arzneimittel AG Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland |
EU/1/16/1161 |
Injekcinis tirpalas |
H05AA02 |
2017 1 13 |
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2017 1 11 |
Suliqua |
insulinum glarginum + lixisenatidum |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/16/1157 |
Injekcinis tirpalas |
A10AE54 |
2017 1 13 |
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2017 1 18 |
ZINPLAVA |
bezlotoksumabas |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/16/1156 |
Koncentratas infuziniam tirpalui |
J06BB21 |
2017 1 20 |
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2017 1 19 |
Cystadrops |
merkaptaminas |
Orphan Europe SARL Immeuble „Le Wilson“, 70, Avenue du Général de Gaulle, 92800 Puteaux, France |
EU/1/15/1049 |
Akių lašai, tirpalas |
S01XA21 |
2017 1 23 |
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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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2017 1 4 |
Emadine |
Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
EU/1/98/095 |
2017 1 6 |
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2017 1 4 |
Imatinib Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/845 |
2017 1 6 |
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2017 1 4 |
Incruse |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/922 |
2017 1 6 |
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2017 1 4 |
Kolbam |
Retrophin Europe Limited Palmerstown House, Fenian Street, Dublin 2, Ireland |
EU/1/13/895 |
2017 1 6 |
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2017 1 4 |
Vepacel |
Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika |
EU/1/12/752 |
2017 1 6 |
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2017 1 4 |
Zonegran |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/04/307 |
2017 1 6 |
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2017 1 9 |
Capecitabine Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/12/762 |
2017 1 11 |
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2017 1 9 |
Capecitabine Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/761 |
2017 1 11 |
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2017 1 9 |
DaTSCAN |
GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom |
EU/1/00/135 |
2017 1 11 |
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2017 1 9 |
Foclivia |
Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/09/577 |
2017 1 11 |
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2017 1 9 |
Naglazyme |
BioMarin Europe Ltd. 10 Bloomsbury Way, London WC1A 2SL, United Kingdom |
EU/1/05/324 |
2017 1 13 |
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2017 1 9 |
Ofev |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/979 |
2017 1 11 |
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2017 1 9 |
Relistor |
PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika |
EU/1/08/463 |
2017 1 11 |
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2017 1 9 |
Riluzole Zentiva |
Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France |
EU/1/12/768 |
2017 1 11 |
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2017 1 9 |
SANCUSO |
Kyowa Kirin Limited Galabank Business Park, Galashiels, TD1 1QH, United Kingdom |
EU/1/12/766 |
2017 1 11 |
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2017 1 9 |
Translarna |
PTC Therapeutics International Limited 77 Sir John Rogerson’s Quay, Dublin 2, Ireland |
EU/1/13/902 |
2017 1 11 |
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2017 1 9 |
Viagra |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/98/077 |
2017 1 11 |
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2017 1 9 |
Viramune |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/97/055 |
2017 1 11 |
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2017 1 9 |
Xultophy |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Danmark |
EU/1/14/947 |
2017 1 11 |
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2017 1 11 |
Adenuric |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/08/447 |
2017 1 13 |
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2017 1 11 |
Brintellix |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/13/891 |
2017 1 13 |
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2017 1 11 |
Bronchitol |
Pharmaxis Pharmaceuticals Limited 25 Moorgate, London, EC2R 6AY, United Kingdom. |
EU/1/12/760 |
2017 1 13 |
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2017 1 11 |
Cometriq |
Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France |
EU/1/13/890 |
2017 1 13 |
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2017 1 11 |
Defitelio |
Gentium S.r.l Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia |
EU/1/13/878 |
2017 1 16 |
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2017 1 11 |
Entresto |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/1058 |
2017 1 13 |
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2017 1 11 |
Herceptin |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/00/145 |
2017 1 13 |
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2017 1 11 |
Imatinib Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/845 |
2017 1 13 |
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2017 1 11 |
Inovelon |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/06/378 |
2017 1 13 |
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2017 1 11 |
Invanz |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/02/216 |
2017 1 13 |
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2017 1 11 |
Ivemend |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/437 |
2017 1 13 |
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2017 1 11 |
Kuvan |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland |
EU/1/08/481 |
2017 1 13 |
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2017 1 11 |
Pregabalinas Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/15/997 |
2017 1 13 |
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2017 1 11 |
Pregabalinas Mylan Pharma |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/15/998 |
2017 1 13 |
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2017 1 11 |
Ruconest |
Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland |
EU/1/10/641 |
2017 1 13 |
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2017 1 11 |
Vimizim |
BioMarin Europe Ltd. 10 Bloomsbury Way, London WC1A 2SL, United Kingdom |
EU/1/14/914 |
2017 1 13 |
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2017 1 11 |
Xadago |
Zambon S.p.A. Via Lillo del Duca 10, 20 091 Bresso (MI), Italia |
EU/1/14/984 |
2017 1 13 |
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2017 1 19 |
Jardiance |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/930 |
2017 1 23 |
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2017 1 23 |
Lymphoseek |
Norgine B.V. Hogehilweg 7, 1101CA Amsterdam, Nederland |
EU/1/14/955 |
2017 1 25 |
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2017 1 23 |
Remsima |
Celltrion Healthcare Hungary Kft. Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország |
EU/1/13/853 |
2017 1 25 |
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2017 1 26 |
Cinryze |
Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
EU/1/11/688 |
2017 1 30 |
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2017 1 26 |
Iclusig |
Incyte Biosciences UK Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom |
EU/1/13/839 |
2017 1 30 |
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2017 1 26 |
NovoSeven |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Danmark |
EU/1/96/006 |
2017 1 30 |
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2017 1 26 |
Orfadin |
Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige |
EU/1/04/303 |
2017 1 30 |
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2017 1 26 |
Picato |
LEO Laboratories Ltd. 285 Cashel Road, Crumlin, Dublin 12, Ireland |
EU/1/12/796 |
2017 1 30 |
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2017 1 26 |
Rezolsta |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/967 |
2017 1 30 |
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2017 1 26 |
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 |
2017 1 30 |
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2017 1 27 |
Ameluz |
Biofrontera Bioscience GmbH Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland |
EU/1/11/740 |
2017 1 31 |
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2017 1 27 |
Benepali |
Samsung Bioepis UK Limited 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom |
EU/1/15/1074 |
2017 1 31 |
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2017 1 27 |
Docetaxel Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/12/769 |
2017 1 31 |
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2017 1 27 |
Jentadueto |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/12/780 |
2017 1 31 |
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2017 1 27 |
KEYTRUDA |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/15/1024 |
2017 1 31 |
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2017 1 27 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1014 |
2017 1 31 |
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2017 1 27 |
Stivarga |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/13/858 |
2017 1 31 |
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2017 1 27 |
Trajenta |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/11/707 |
2017 1 31 |
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2017 1 27 |
Vaxelis |
MCM Vaccine B.V. Robert Boyleweg 4, 2333 CG Leiden, Nederland |
EU/1/15/1079 |
2017 1 31 |
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2017 1 27 |
Votubia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/11/710 |
2017 1 31 |
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2017 1 27 |
Xydalba |
Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland |
EU/1/14/986 |
2017 1 31 |
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— |
Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis) |
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Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
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2017 1 9 |
Vylaer Spiromax |
Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland |
EU/1/14/949 |
2017 1 11 |
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2017 1 18 |
Clopidogrel Acino |
Acino AG Am Windfeld 35, 83714 D-Miesbach, Deutschland |
EU/1/09/532 |
2017 1 20 |
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— |
Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 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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2017 1 9 |
Coliprotec F4/F18 |
Vakcina (gyvoji) nuo viduriavimo nujunkytiems paršeliams |
Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland |
EU/2/16/202 |
Liofilizatas geriamajai suspensijai |
QI09AE03 |
2017 1 11 |
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— |
Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta |
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Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
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2017 1 9 |
Novaquin |
Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland |
EU/2/15/186 |
2017 1 11 |
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2017 1 18 |
Nobilis IB 4-91 |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/98/006 |
2017 1 20 |
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2017 1 18 |
Simparica |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/15/191 |
2017 1 20 |
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 |
(1) OL L 136, 2004 4 30, p. 1.