# Europos Sąjungos C 266/2018

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 266 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 61 metai2018m. liepos 27d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 266

Leidimas lietuvių kalba

Informacija ir pranešimai

61 metai2018m. liepos 27d.

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| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2018/C 266/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. birželio 1 d. iki 2018 m. birželio 30 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2018/C 266/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. birželio 1 d. iki 2018 m. birželio 30 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

1

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| LT | |
| --- | --- |

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 27.7.2018 | LT | Europos Sąjungos oficialusis leidinys | C 266/1 |
| --- | --- | --- | --- |

27.7.2018

LT

Europos Sąjungos oficialusis leidinys

C 266/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. birželio 1 d. iki 2018 m. birželio 30 d.

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį)

(2018/C 266/01)

| — | Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis):

  Priimta |
| --- | --- |

—

Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 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 6 18 | Blincyto | Blinatumomabas | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | Milteliai koncentratui infuziniam tirpalui | L01XC19 | 2018 6 20 |
| 2018 6 21 | Biktarvy | biktegraviras / emtricitabinas / tenofoviras alafenamidas | Gilead Sciences International Limited
  Cambridge CB21 6GT United Kingdom | EU/1/18/1289 | Plėvele dengta tabletė | J05AR20 | 2018 6 25 |
| 2018 6 25 | Dzuveo | Sufentanilis | FGK Representative Service GmbH
  Heimeranstraße 35, 80339 München, Deutschland | EU/1/18/1284 | Poliežuvinės tabletės | N01AH03 | 2018 6 27 |

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 6 18

Blincyto

Blinatumomabas

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

Milteliai koncentratui infuziniam tirpalui

L01XC19

2018 6 20

2018 6 21

Biktarvy

biktegraviras / emtricitabinas / tenofoviras alafenamidas

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/18/1289

Plėvele dengta tabletė

J05AR20

2018 6 25

2018 6 25

Dzuveo

Sufentanilis

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/18/1284

Poliežuvinės tabletės

N01AH03

2018 6 27

| — | Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta |
| --- | --- |

—

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 6 4 | Copalia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/372 | 2018 6 6 |
| 2018 6 4 | Emtriva | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/03/261 | 2018 6 6 |
| 2018 6 4 | Iclusig | Incyte Biosciences Distribution B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/13/839 | 2018 6 6 |
| 2018 6 4 | Prolia | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/10/618 | 2018 6 6 |
| 2018 6 4 | Stocrin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/111 | 2018 6 6 |
| 2018 6 4 | Stribild | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/830 | 2018 6 6 |
| 2018 6 4 | Truvada | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/04/305 | 2018 6 6 |
| 2018 6 4 | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 2018 6 6 |
| 2018 6 4 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 2018 6 6 |
| 2018 6 7 | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/16/1098 | 2018 6 11 |
| 2018 6 7 | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 2018 6 11 |
| 2018 6 7 | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 2018 6 11 |
| 2018 6 7 | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/14/974 | 2018 6 11 |
| 2018 6 7 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 2018 6 11 |
| 2018 6 7 | Constella | Allergan Pharmaceuticals International Limited
  Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland | EU/1/12/801 | 2018 6 11 |
| 2018 6 7 | Dafiro | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/371 | 2018 6 11 |
| 2018 6 7 | Exforge HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/569 | 2018 6 11 |
| 2018 6 7 | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 2018 6 11 |
| 2018 6 7 | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 2018 6 11 |
| 2018 6 7 | Isentress | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/436 | 2018 6 11 |
| 2018 6 7 | Pemetrexed Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1071 | 2018 6 11 |
| 2018 6 7 | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 2018 6 11 |
| 2018 6 7 | Quinsair | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/973 | 2018 6 11 |
| 2018 6 7 | SomaKit TOC | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/16/1141 | 2018 6 11 |
| 2018 6 7 | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1086 | 2018 6 11 |
| 2018 6 7 | Uptravi | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/15/1083 | 2018 6 11 |
| 2018 6 7 | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 2018 6 11 |
| 2018 6 7 | Vosevi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/17/1223 | 2018 6 11 |
| 2018 6 7 | Votubia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/710 | 2018 6 11 |
| 2018 6 7 | Xultophy | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/14/947 | 2018 6 11 |
| 2018 6 7 | Zydelig | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/938 | 2018 6 11 |
| 2018 6 7 | Zykadia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/999 | 2018 6 11 |
| 2018 6 12 | Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1133 | 2018 6 14 |
| 2018 6 12 | Fareston | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/96/004 | 2018 6 14 |
| 2018 6 12 | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 2018 6 14 |
| 2018 6 12 | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 2018 6 14 |
| 2018 6 14 | Insuman | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/97/030 | 2018 6 19 |
| 2018 6 14 | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/98/070 | 2018 6 19 |
| 2018 6 14 | SOLYMBIC | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1163 | 2018 6 19 |
| 2018 6 15 | Aerinaze | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/399 | 2018 6 19 |
| 2018 6 15 | Lusduna | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1162 | 2018 6 19 |
| 2018 6 15 | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 2018 6 19 |
| 2018 6 15 | Neoclarityn | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/161 | 2018 6 19 |
| 2018 6 15 | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/312 | 2018 6 19 |
| 2018 6 15 | Zepatier | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1119 | 2018 6 19 |
| 2018 6 15 | Zerbaxa | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1032 | 2018 6 19 |
| 2018 6 15 | ZINPLAVA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1156 | 2018 6 19 |
| 2018 6 21 | Inflectra | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/13/854 | 2018 6 25 |
| 2018 6 21 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 2018 6 25 |
| 2018 6 21 | Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/10/637 | 2018 6 25 |
| 2018 6 21 | Panretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/149 | 2018 6 25 |
| 2018 6 21 | Remsima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/13/853 | 2018 6 25 |
| 2018 6 21 | Rolufta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | 2018 6 25 |
| 2018 6 21 | Targretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/01/178 | 2018 6 25 |
| 2018 6 21 | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 2018 6 25 |
| 2018 6 21 | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 2018 6 25 |
| 2018 6 25 | Copalia HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/575 | 2018 6 27 |
| 2018 6 25 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 2018 6 27 |
| 2018 6 25 | Dafiro HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/574 | 2018 6 27 |
| 2018 6 25 | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/16/1101 | 2018 6 27 |
| 2018 6 25 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 2018 6 27 |
| 2018 6 25 | Exforge | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/370 | 2018 6 27 |
| 2018 6 25 | Glivec | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/198 | 2018 6 27 |
| 2018 6 25 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/09/604 | 2018 6 27 |
| 2018 6 25 | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 2018 6 27 |
| 2018 6 25 | Orbactiv | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/15/989 | 2018 6 27 |
| 2018 6 25 | PANTOLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/519 | 2018 6 27 |
| 2018 6 25 | Pantoprazolas | | | 2018 6 26 |
| 2018 6 25 | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 2018 6 27 |
| 2018 6 25 | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 2018 6 27 |
| 2018 6 25 | Xgeva | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/11/703 | 2018 6 27 |
| 2018 6 25 | Yondelis | Pharma Mar S.A.
  Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 2018 6 27 |
| 2018 6 29 | Aerius | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/160 | 2018 7 3 |
| 2018 6 29 | Azomyr | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/157 | 2018 7 3 |
| 2018 6 29 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 2018 7 3 |
| 2018 6 29 | Efficib | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/457 | 2018 7 3 |
| 2018 6 29 | Granupas | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/13/896 | 2018 7 3 |
| 2018 6 29 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 2018 7 3 |
| 2018 6 29 | Janumet | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/455 | 2018 7 3 |
| 2018 6 29 | Jinarc | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | 2018 7 3 |
| 2018 6 29 | Olumiant | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1170 | 2018 7 3 |
| 2018 6 29 | Orgalutran | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/130 | 2018 7 3 |
| 2018 6 29 | Revlimid | Celgene Europe B.V.
  Winthonlaan 6N, 3526 KV Utrecht, Nederland | EU/1/07/391 | 2018 7 3 |
| 2018 6 29 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 2018 7 3 |
| 2018 6 29 | Ristfor | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/10/620 | 2018 7 3 |
| 2018 6 29 | Samsca | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/09/539 | 2018 7 3 |
| 2018 6 29 | Spectrila | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/15/1072 | 2018 7 3 |
| 2018 6 29 | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 2018 7 3 |
| 2018 6 29 | Velmetia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/456 | 2018 7 3 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 6 4

Copalia

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/372

2018 6 6

2018 6 4

Emtriva

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/261

2018 6 6

2018 6 4

Iclusig

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

2018 6 6

2018 6 4

Prolia

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

2018 6 6

2018 6 4

Stocrin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

2018 6 6

2018 6 4

Stribild

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/830

2018 6 6

2018 6 4

Truvada

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

2018 6 6

2018 6 4

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

2018 6 6

2018 6 4

Zinbryta

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/16/1107

2018 6 6

2018 6 7

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

2018 6 11

2018 6 7

BeneFIX

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/97/047

2018 6 11

2018 6 7

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

2018 6 11

2018 6 7

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/14/974

2018 6 11

2018 6 7

Cimzia

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/09/544

2018 6 11

2018 6 7

Constella

Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland

EU/1/12/801

2018 6 11

2018 6 7

Dafiro

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/371

2018 6 11

2018 6 7

Exforge HCT

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/09/569

2018 6 11

2018 6 7

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

2018 6 11

2018 6 7

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

2018 6 11

2018 6 7

Isentress

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/436

2018 6 11

2018 6 7

Pemetrexed Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1071

2018 6 11

2018 6 7

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

2018 6 11

2018 6 7

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/973

2018 6 11

2018 6 7

SomaKit TOC

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/16/1141

2018 6 11

2018 6 7

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

2018 6 11

2018 6 7

Uptravi

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/15/1083

2018 6 11

2018 6 7

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

2018 6 11

2018 6 7

Vosevi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

2018 6 11

2018 6 7

Votubia

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/11/710

2018 6 11

2018 6 7

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

2018 6 11

2018 6 7

Zydelig

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/938

2018 6 11

2018 6 7

Zykadia

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/15/999

2018 6 11

2018 6 12

Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1133

2018 6 14

2018 6 12

Fareston

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

2018 6 14

2018 6 12

Incruse

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/14/922

2018 6 14

2018 6 12

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

2018 6 14

2018 6 14

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

2018 6 19

2018 6 14

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/070

2018 6 19

2018 6 14

SOLYMBIC

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1163

2018 6 19

2018 6 15

Aerinaze

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/399

2018 6 19

2018 6 15

Lusduna

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1162

2018 6 19

2018 6 15

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

2018 6 19

2018 6 15

Neoclarityn

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/00/161

2018 6 19

2018 6 15

Xyrem

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/05/312

2018 6 19

2018 6 15

Zepatier

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1119

2018 6 19

2018 6 15

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

2018 6 19

2018 6 15

ZINPLAVA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1156

2018 6 19

2018 6 21

Inflectra

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/13/854

2018 6 25

2018 6 21

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

2018 6 25

2018 6 21

Leflunomide medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/10/637

2018 6 25

2018 6 21

Panretin

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/00/149

2018 6 25

2018 6 21

Remsima

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/13/853

2018 6 25

2018 6 21

Rolufta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

2018 6 25

2018 6 21

Targretin

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/01/178

2018 6 25

2018 6 21

Xeljanz

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/17/1178

2018 6 25

2018 6 21

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

2018 6 25

2018 6 25

Copalia HCT

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/09/575

2018 6 27

2018 6 25

Cubicin

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/328

2018 6 27

2018 6 25

Dafiro HCT

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/09/574

2018 6 27

2018 6 25

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

2018 6 27

2018 6 25

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

2018 6 27

2018 6 25

Exforge

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/370

2018 6 27

2018 6 25

Glivec

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/01/198

2018 6 27

2018 6 25

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604

2018 6 27

2018 6 25

Nexium Control

Pfizer Consumer Healthcare Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/13/860

2018 6 27

2018 6 25

Orbactiv

The Medicines Company UK Ltd

115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom

EU/1/15/989

2018 6 27

2018 6 25

PANTOLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/519

2018 6 27

2018 6 25

Pantoprazolas

2018 6 26

2018 6 25

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

2018 6 27

2018 6 25

Xeljanz

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/17/1178

2018 6 27

2018 6 25

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

2018 6 27

2018 6 25

Yondelis

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

EU/1/07/417

2018 6 27

2018 6 29

Aerius

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/160

2018 7 3

2018 6 29

Azomyr

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/157

2018 7 3

2018 6 29

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

2018 7 3

2018 6 29

Efficib

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/457

2018 7 3

2018 6 29

Granupas

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/896

2018 7 3

2018 6 29

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

2018 7 3

2018 6 29

Janumet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/455

2018 7 3

2018 6 29

Jinarc

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/15/1000

2018 7 3

2018 6 29

Olumiant

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

2018 7 3

2018 6 29

Orgalutran

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/00/130

2018 7 3

2018 6 29

Revlimid

Celgene Europe B.V.

Winthonlaan 6N, 3526 KV Utrecht, Nederland

EU/1/07/391

2018 7 3

2018 6 29

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

2018 7 3

2018 6 29

Ristfor

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/620

2018 7 3

2018 6 29

Samsca

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/09/539

2018 7 3

2018 6 29

Spectrila

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1072

2018 7 3

2018 6 29

Temozolomide Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/10/615

2018 7 3

2018 6 29

Velmetia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/456

2018 7 3

| — | Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis) |
| --- | --- |

—

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 6 15 | SOLYMBIC | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1163 | 2018 6 19 |
| 2018 6 21 | Angiox | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/04/289 | 2018 6 25 |
| 2018 6 29 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 2018 7 3 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 6 15

SOLYMBIC

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1163

2018 6 19

2018 6 21

Angiox

The Medicines Company UK Ltd

115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom

EU/1/04/289

2018 6 25

2018 6 29

Victrelis

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/11/704

2018 7 3

| — | Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis):

  Priimta |
| --- | --- |

—

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 6 14 | Dany's BienenWohl | oksalo rūgšties dihidratas | Dany Bienenwohl GmbH
  Geyerspergerstraße 27, 80689 München, Deutschland | EU/2/18/225 | Milteliai ir tirpalas avilio dispersijai | QP53AG03 | 2018 6 19 |

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 6 14

Dany's BienenWohl

oksalo rūgšties dihidratas

Dany Bienenwohl GmbH

Geyerspergerstraße 27, 80689 München, Deutschland

EU/2/18/225

Milteliai ir tirpalas avilio dispersijai

QP53AG03

2018 6 19

| — | Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta |
| --- | --- |

—

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 6 4 | Activyl | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/10/118 | 2018 6 6 |
| 2018 6 4 | Cepedex | CP-Pharma Handelsgesellschaft mbH
  Ostlandring 13, 31303 Burgdorf, Deutschland | EU/2/16/200 | 2018 6 6 |
| 2018 6 11 | Veraflox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/10/107 | 2018 6 13 |
| 2018 6 14 | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/153 | 2018 6 19 |
| 2018 6 18 | Rhiniseng | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/10/109 | 2018 6 20 |
| 2018 6 27 | BROADLINE | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/157 | 2018 6 29 |
| 2018 6 27 | Evalon | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/16/194 | 2018 6 29 |
| 2018 6 27 | Porcilis PCV M Hyo | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/14/175 | 2018 6 29 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 6 4

Activyl

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/118

2018 6 6

2018 6 4

Cepedex

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/16/200

2018 6 6

2018 6 11

Veraflox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/10/107

2018 6 13

2018 6 14

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/153

2018 6 19

2018 6 18

Rhiniseng

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/10/109

2018 6 20

2018 6 27

BROADLINE

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/157

2018 6 29

2018 6 27

Evalon

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/16/194

2018 6 29

2018 6 27

Porcilis PCV M Hyo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

2018 6 29

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 |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  OL L 136, 2004 4 30, p. 1.

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