ISSN 1977-0960
Europos Sąjungos
oficialusis leidinys
C 309
Leidimas lietuvių kalba
Informacija ir pranešimai
61 metai
2018m. rugpjūčio 31d.
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ISSN 1977-0960 |
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Europos Sąjungos oficialusis leidinys |
C 309 |
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Leidimas lietuvių kalba |
Informacija ir pranešimai |
61 metai |
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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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2018/C 309/01 |
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LT |
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IV Pranešimai
EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI
Europos Komisija
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31.8.2018 |
LT |
Europos Sąjungos oficialusis leidinys |
C 309/1 |
Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. liepos 1 d. iki 2018 m. liepos 31 d.
(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį)
(2018/C 309/01)
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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 |
|
2018 7 6 |
Tegsedi |
inoterseno |
IONIS USA Limited Tower 42, Level 30, International Finance Centre, 25 Old Broad Street, EC2N 1HQ London, United Kingdom |
EU/1/18/1296 |
Injekcinis tirpalas |
Pending |
2018 7 10 |
|
2018 7 6 |
Verkazia |
Ciklosporinas |
Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi |
EU/1/17/1219 |
Akių lašai (emulsija) |
S01XA18 |
2018 7 10 |
|
2018 7 26 |
Aimovig |
erenumabas |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/18/1293 |
Injekcinis tirpalas |
N02C |
2018 7 30 |
|
2018 7 26 |
Halimatoz |
adalimumabas |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/18/1288 |
Injekcinis tirpalas |
L04AB04 |
2018 7 30 |
|
2018 7 26 |
Hefiya |
adalimumabas |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/18/1287 |
Injekcinis tirpalas |
L04AB04 |
2018 7 30 |
|
2018 7 26 |
Hyrimoz |
adalimumabas |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/18/1286 |
Injekcinis tirpalas |
L04AB04 |
2018 7 30 |
|
2018 7 26 |
Nityr |
nitizinonas |
Cycle Pharmaceuticals Ltd Bailey Grundy Barrett Building, Little St Mary’s Lane, CB2 1RR, Cambridge, United Kingdom |
EU/1/18/1290 |
Tabletės |
A16AX04 |
2018 7 30 |
|
2018 7 26 |
RXULTI |
brexpiprazolum |
Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/18/1294 |
Plėvele dengta tabletė |
N05AX16 |
2018 7 30 |
|
2018 7 26 |
Trazimera |
trastuzumabas |
Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/18/1295 |
Milteliai koncentratui infuziniam tirpalui |
L01XC03 |
2018 7 30 |
|
2018 7 30 |
Myalepta |
metreleptinas |
Aegerion Pharmaceuticals B.V. Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland |
EU/1/18/1276 |
Milteliai injekciniam tirpalui |
A16AA07 |
2018 8 1 |
|
— |
Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Atmesta |
|
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
|
2018 7 17 |
Aplidin |
Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España |
— |
2018 7 19 |
|
2018 7 26 |
Alsitek |
AB Science 3 avenue George V, 75008 Paris, France |
— |
2018 7 30 |
|
— |
Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta |
|
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
|
2018 7 2 |
Bavencio |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |
EU/1/17/1214 |
2018 7 4 |
|
2018 7 2 |
CONTROLOC Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/515 |
2018 7 4 |
|
2018 7 2 |
DepoCyte |
Pacira Limited Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom |
EU/1/01/187 |
2018 7 4 |
|
2018 7 2 |
Docetaxel Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/12/769 |
2018 7 4 |
|
2018 7 2 |
Enurev Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/12/789 |
2018 7 4 |
|
2018 7 2 |
Ifirmacombi |
Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/11/673 |
2018 7 4 |
|
2018 7 2 |
Lemtrada |
Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom |
EU/1/13/869 |
2018 7 4 |
|
2018 7 2 |
Mysimba |
Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland |
EU/1/14/988 |
2018 7 4 |
|
2018 7 2 |
PANTOZOL Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/517 |
2018 7 4 |
|
2018 7 2 |
Prialt |
RIEMSER Pharma GmbH An der Wiek 7, 17493 Greifswald-Insel Riems, Deutschland |
EU/1/04/302 |
2018 7 4 |
|
2018 7 2 |
Simponi |
Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland |
EU/1/09/546 |
2018 7 4 |
|
2018 7 2 |
SOMAC Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/516 |
2018 7 4 |
|
2018 7 2 |
Sprycel |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/06/363 |
2018 7 4 |
|
2018 7 2 |
Tecentriq |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/17/1220 |
2018 7 4 |
|
2018 7 2 |
Trulicity |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/14/956 |
2018 7 3 |
|
2018 7 2 |
Xarelto |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/08/472 |
2018 7 4 |
|
2018 7 6 |
Adrovance |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/06/364 |
2018 7 10 |
|
2018 7 6 |
ALPROLIX |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige |
EU/1/16/1098 |
2018 7 10 |
|
2018 7 6 |
Ammonaps |
Swedish Orphan Biovitrum International AB 112 76 Stockholm, Sverige |
EU/1/99/120 |
2018 7 10 |
|
2018 7 6 |
Ariclaim |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/283 |
2018 7 10 |
|
2018 7 6 |
Corbilta |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
EU/1/13/859 |
2018 7 10 |
|
2018 7 6 |
Fertavid |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/09/510 |
2018 7 10 |
|
2018 7 6 |
Hirobriz Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/594 |
2018 7 10 |
|
2018 7 6 |
KEYTRUDA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/1024 |
2018 7 10 |
|
2018 7 6 |
Ninlaro |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/16/1094 |
2018 7 10 |
|
2018 7 6 |
Noxafil |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/05/320 |
2018 7 10 |
|
2018 7 6 |
Pemetrexed Fresenius Kabi |
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |
EU/1/16/1115 |
2018 7 10 |
|
2018 7 6 |
Pemetrexed Sandoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/15/1037 |
2018 7 10 |
|
2018 7 6 |
Praxbind |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1056 |
2018 7 10 |
|
2018 7 6 |
PREZISTA |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/06/380 |
2018 7 10 |
|
2018 7 6 |
Puregon |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/96/008 |
2018 7 10 |
|
2018 7 6 |
Revolade |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/10/612 |
2018 7 10 |
|
2018 7 6 |
Sovaldi |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/13/894 |
2018 7 10 |
|
2018 7 6 |
Symtuza |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/17/1225 |
2018 7 10 |
|
2018 7 6 |
Tafinlar |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/13/865 |
2018 7 10 |
|
2018 7 6 |
Temozolomide HEXAL |
Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland |
EU/1/10/616 |
2018 7 10 |
|
2018 7 6 |
Temozolomide Sandoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/10/617 |
2018 7 10 |
|
2018 7 6 |
Visudyne |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/00/140 |
2018 7 10 |
|
2018 7 6 |
Zykadia |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/15/999 |
2018 7 10 |
|
2018 7 9 |
Betaferon |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/95/003 |
2018 7 11 |
|
2018 7 9 |
Fosavance |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/05/310 |
2018 7 11 |
|
2018 7 9 |
MAVENCLAD |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |
EU/1/17/1212 |
2018 7 11 |
|
2018 7 9 |
Pylobactell |
Torbet Laboratories Limited Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB, United Kingdom |
EU/1/98/064 |
2018 7 11 |
|
2018 7 9 |
Qutenza |
Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland |
EU/1/09/524 |
2018 7 11 |
|
2018 7 9 |
Seebri Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/12/788 |
2018 7 11 |
|
2018 7 9 |
Tovanor Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/12/790 |
2018 7 11 |
|
2018 7 9 |
Vantavo |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/09/572 |
2018 7 11 |
|
2018 7 9 |
Zavesca |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/02/238 |
2018 7 11 |
|
2018 7 11 |
Briviact |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/15/1073 |
2018 7 13 |
|
2018 7 11 |
Byetta |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/06/362 |
2018 7 13 |
|
2018 7 11 |
Erelzi |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/17/1195 |
2018 7 13 |
|
2018 7 11 |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
2018 7 13 |
|
2018 7 11 |
Vizamyl |
GE Healthcare Ltd Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom |
EU/1/14/941 |
2018 7 13 |
|
2018 7 11 |
Xagrid |
Shire Pharmaceutical Contracts Limited 1 Kingdom Street, London W2 6BD, United Kingdom |
EU/1/04/295 |
2018 7 13 |
|
2018 7 13 |
Firdapse |
BioMarin Europe Ltd 10 Bloomsbury Way, London WC1A 2SL, United Kingdom |
EU/1/09/601 |
2018 7 17 |
|
2018 7 13 |
Karvea |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/97/049 |
2018 7 17 |
|
2018 7 13 |
Naglazyme |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork P43 R298, Ireland |
EU/1/05/324 |
2018 7 17 |
|
2018 7 13 |
Rebif |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/98/063 |
2018 7 17 |
|
2018 7 19 |
Dificlir |
Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland |
EU/1/11/733 |
2018 7 23 |
|
2018 7 19 |
Irbesartan Zentiva |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/06/376 |
2018 7 23 |
|
2018 7 19 |
Lopinavir/Ritonavir Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/15/1067 |
2018 7 23 |
|
2018 7 19 |
Optruma |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/98/074 |
2018 7 23 |
|
2018 7 19 |
PecFent |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/10/644 |
2018 7 23 |
|
2018 7 19 |
Plegridy |
Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |
EU/1/14/934 |
2018 7 23 |
|
2018 7 19 |
Qarziba |
EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, Hemel Hempstead HP2 4TZ, United Kingdom |
EU/1/17/1191 |
2018 7 23 |
|
2018 7 19 |
Rituzena |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |
EU/1/17/1206 |
2018 7 23 |
|
2018 7 19 |
SANCUSO |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/12/766 |
2018 7 23 |
|
2018 7 19 |
Translarna |
PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland |
EU/1/13/902 |
2018 7 23 |
|
2018 7 23 |
Bemfola |
Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország |
EU/1/13/909 |
2018 7 25 |
|
2018 7 23 |
Eperzan |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/13/908 |
2018 7 25 |
|
2018 7 23 |
Exjade |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/356 |
2018 7 25 |
|
2018 7 23 |
Ivemend |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/07/437 |
2018 7 25 |
|
2018 7 23 |
Moventig |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/14/962 |
2018 7 25 |
|
2018 7 23 |
Parsabiv |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/16/1142 |
2018 7 25 |
|
2018 7 23 |
PREVYMIS |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/17/1245 |
2018 7 25 |
|
2018 7 23 |
Translarna |
PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland |
EU/1/13/902 |
2018 7 25 |
|
2018 7 23 |
Ultibro Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/13/862 |
2018 7 25 |
|
2018 7 23 |
Vargatef |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/954 |
2018 7 25 |
|
2018 7 23 |
Viread |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/01/200 |
2018 7 25 |
|
2018 7 23 |
Xoterna Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/13/863 |
2018 7 25 |
|
2018 7 26 |
Besponsa |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/17/1200 |
2018 7 30 |
|
2018 7 26 |
Ceplene |
Noventia Pharma Srl Via Carlo Pisacane 31, 47121 Forli, Italia |
EU/1/08/477 |
2018 7 30 |
|
2018 7 26 |
Esmya |
Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország |
EU/1/12/750 |
2018 7 30 |
|
2018 7 26 |
Fareston |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
EU/1/96/004 |
2018 7 30 |
|
2018 7 26 |
Genvoya |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/15/1061 |
2018 7 30 |
|
2018 7 26 |
Invokana |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/13/884 |
2018 7 30 |
|
2018 7 26 |
Jinarc |
Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/15/1000 |
2018 7 30 |
|
2018 7 26 |
Lixiana |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland |
EU/1/15/993 |
2018 7 30 |
|
2018 7 26 |
NovoEight |
Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark |
EU/1/13/888 |
2018 7 30 |
|
2018 7 26 |
Ofev |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/979 |
2018 7 30 |
|
2018 7 26 |
Procysbi |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/13/861 |
2018 7 30 |
|
2018 7 26 |
Rasagiline ratiopharm |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/14/977 |
2018 7 30 |
|
2018 7 26 |
Relvar Ellipta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/13/886 |
2018 7 30 |
|
2018 7 26 |
Revinty Ellipta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/929 |
2018 7 30 |
|
2018 7 26 |
Segluromet |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/18/1265 |
2018 7 30 |
|
2018 7 26 |
Trisenox |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/02/204 |
2018 7 30 |
|
2018 7 26 |
Tybost |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/13/872 |
2018 7 30 |
|
2018 7 26 |
Zalmoxis |
MolMed S.p.A. Via Olgettina 58, 20132 Milano, Italia |
EU/1/16/1121 |
2018 7 30 |
|
2018 7 30 |
Abraxane |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/07/428 |
2018 8 1 |
|
2018 7 30 |
Aprovel |
Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France |
EU/1/97/046 |
2018 8 1 |
|
2018 7 30 |
Arzerra |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/625 |
2018 8 1 |
|
2018 7 30 |
Bridion |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/08/466 |
2018 8 1 |
|
2018 7 30 |
Champix |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/06/360 |
2018 8 1 |
|
2018 7 30 |
Cyanokit |
SERB S.A. Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België |
EU/1/07/420 |
2018 8 1 |
|
2018 7 30 |
Enbrel |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/99/126 |
2018 8 1 |
|
2018 7 30 |
Eylea |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/12/797 |
2018 8 1 |
|
2018 7 30 |
Grastofil |
Apotex Europe B.V. Archimedesweg 2, 2333 CN Leiden, Nederland |
EU/1/13/877 |
2018 8 1 |
|
2018 7 30 |
HALAVEN |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/11/678 |
2018 8 1 |
|
2018 7 30 |
IBRANCE |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/16/1147 |
2018 8 1 |
|
2018 7 30 |
Ilaris |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/564 |
2018 8 1 |
|
2018 7 30 |
Imlygic |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/15/1064 |
2018 8 1 |
|
2018 7 30 |
Inflectra |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/13/854 |
2018 8 1 |
|
2018 7 30 |
Intelence |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/08/468 |
2018 8 1 |
|
2018 7 30 |
Lyrica |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/04/279 |
2018 8 1 |
|
2018 7 30 |
Mylotarg |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/18/1277 |
2018 8 1 |
|
2018 7 30 |
Nimenrix |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/12/767 |
2018 8 1 |
|
2018 7 30 |
NovoEight |
Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark |
EU/1/13/888 |
2018 8 1 |
|
2018 7 30 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1014 |
2018 8 1 |
|
2018 7 30 |
Pregabalin Pfizer |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/14/916 |
2018 8 1 |
|
2018 7 30 |
Revatio |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/05/318 |
2018 8 1 |
|
2018 7 30 |
Stocrin |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/99/111 |
2018 8 1 |
|
2018 7 30 |
Strimvelis |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/16/1097 |
2018 8 1 |
|
2018 7 30 |
Temozolomide SUN |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland |
EU/1/11/697 |
2018 8 1 |
|
2018 7 30 |
Temozolomide Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/606 |
2018 8 1 |
|
2018 7 30 |
Thalidomide Celgene |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/08/443 |
2018 8 1 |
|
2018 7 30 |
Toviaz |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/07/386 |
2018 8 1 |
|
2018 7 30 |
Tygacil |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/06/336 |
2018 8 1 |
|
2018 7 30 |
Tyverb |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/440 |
2018 8 1 |
|
2018 7 30 |
Ucedane |
Lucane Pharma 172 rue de Charonne, 75011 Paris, France |
EU/1/17/1202 |
2018 8 1 |
|
2018 7 30 |
Viagra |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/98/077 |
2018 8 1 |
|
2018 7 30 |
Vidaza |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/08/488 |
2018 8 1 |
|
— |
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 7 6 |
DepoCyte |
Pacira Limited Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom |
EU/1/01/187 |
2018 7 10 |
|
2018 7 9 |
Ariclaim |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/283 |
2018 7 11 |
|
2018 7 19 |
Trobalt |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/11/681 |
2018 7 23 |
|
— |
Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta |
|
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 |
|
2018 7 26 |
UBAC |
Streptococcus uberis vakcina (inaktyvinta) |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/18/227 |
Injekcinė emulsija |
QI02AB |
2018 7 30 |
|
— |
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 |
|
2018 7 2 |
ERYSENG PARVO |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/14/167 |
2018 7 4 |
|
2018 7 2 |
Zolvix |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/09/101 |
2018 7 4 |
|
2018 7 5 |
Pexion |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/12/147 |
2018 7 9 |
|
2018 7 9 |
Coliprotec F4/F18 |
Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland |
EU/2/16/202 |
2018 7 11 |
|
2018 7 9 |
Credelio |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/17/206 |
2018 7 11 |
|
2018 7 9 |
ERYSENG |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/14/166 |
2018 7 11 |
|
2018 7 9 |
Hiprabovis IBR Marker Live |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/10/114 |
2018 7 11 |
|
2018 7 9 |
Trocoxil |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/08/084 |
2018 7 11 |
|
2018 7 10 |
Econor |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/98/010 |
2018 7 12 |
|
2018 7 12 |
Procox |
Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland |
EU/2/11/123 |
2018 7 16 |
|
2018 7 13 |
Reconcile |
Nexcyon Pharmaceuticals Ltd First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom |
EU/2/08/080 |
2018 7 16 |
|
2018 7 23 |
Nobivac L4 |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/12/143 |
2018 7 25 |
|
2018 7 23 |
Respiporc Flu3 |
IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Rosslau, Deutschland |
EU/2/09/103 |
2018 7 25 |
|
2018 7 26 |
Apoquel |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/13/154 |
2018 7 30 |
Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:
|
European Medicines Agency |
|
30 Churchill Place |
|
Canary Wharf |
|
London E14 5EU |
|
United Kingdom |