# Eiropas Savienības C 266/2018

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 266 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 61. gadagājums2018. gada 27. jūlijs |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 266

Izdevums latviešu valodā

Informācija un paziņojumi

61. gadagājums2018. gada 27. jūlijs

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| Saturs | Lappuse |
| --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2018/C 266/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. jūnija līdz 2018. gada 30. jūnijam(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu) | 1 |

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2018/C 266/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. jūnija līdz 2018. gada 30. jūnijam(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)

1

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| LV | |
| --- | --- |

LV

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IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

| 27.7.2018 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 266/1 |
| --- | --- | --- | --- |

27.7.2018

LV

Eiropas Savienības Oficiālais Vēstnesis

C 266/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. jūnija līdz 2018. gada 30. jūnijam

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 (1) 13. vai 38. pantu)

(2018/C 266/01)

| — | Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas |
| --- | --- |

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Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.6.2018. | Blincyto | Blinatumomab | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | Pulveris infūziju šķīduma koncentrāta pagatavošanai | L01XC19 | 20.6.2018. |
| 21.6.2018. | Biktarvy | biktegravīrs / emtricitabīns / tenofovīra alafenamīds | Gilead Sciences International Limited
  Cambridge CB21 6GT United Kingdom | EU/1/18/1289 | Apvalkotās tabletes | J05AR20 | 25.6.2018. |
| 25.6.2018. | Dzuveo | Sufentanils | FGK Representative Service GmbH
  Heimeranstraße 35, 80339 München, Deutschland | EU/1/18/1284 | Tabletes lietošanai zem mēles | N01AH03 | 27.6.2018. |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

18.6.2018.

Blincyto

Blinatumomab

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

Pulveris infūziju šķīduma koncentrāta pagatavošanai

L01XC19

20.6.2018.

21.6.2018.

Biktarvy

biktegravīrs / emtricitabīns / tenofovīra alafenamīds

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/18/1289

Apvalkotās tabletes

J05AR20

25.6.2018.

25.6.2018.

Dzuveo

Sufentanils

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/18/1284

Tabletes lietošanai zem mēles

N01AH03

27.6.2018.

| — | Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas |
| --- | --- |

—

Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 4.6.2018. | Copalia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/372 | 6.6.2018. |
| 4.6.2018. | Emtriva | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/03/261 | 6.6.2018. |
| 4.6.2018. | Iclusig | Incyte Biosciences Distribution B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/13/839 | 6.6.2018. |
| 4.6.2018. | Prolia | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/10/618 | 6.6.2018. |
| 4.6.2018. | Stocrin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/111 | 6.6.2018. |
| 4.6.2018. | Stribild | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/830 | 6.6.2018. |
| 4.6.2018. | Truvada | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/04/305 | 6.6.2018. |
| 4.6.2018. | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 6.6.2018. |
| 4.6.2018. | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 6.6.2018. |
| 7.6.2018. | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/16/1098 | 11.6.2018. |
| 7.6.2018. | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 11.6.2018. |
| 7.6.2018. | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 11.6.2018. |
| 7.6.2018. | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/14/974 | 11.6.2018. |
| 7.6.2018. | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 11.6.2018. |
| 7.6.2018. | Constella | Allergan Pharmaceuticals International Limited
  Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland | EU/1/12/801 | 11.6.2018. |
| 7.6.2018. | Dafiro | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/371 | 11.6.2018. |
| 7.6.2018. | Exforge HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/569 | 11.6.2018. |
| 7.6.2018. | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 11.6.2018. |
| 7.6.2018. | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 11.6.2018. |
| 7.6.2018. | Isentress | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/436 | 11.6.2018. |
| 7.6.2018. | Pemetrexed Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1071 | 11.6.2018. |
| 7.6.2018. | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 11.6.2018. |
| 7.6.2018. | Quinsair | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/973 | 11.6.2018. |
| 7.6.2018. | SomaKit TOC | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/16/1141 | 11.6.2018. |
| 7.6.2018. | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1086 | 11.6.2018. |
| 7.6.2018. | Uptravi | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/15/1083 | 11.6.2018. |
| 7.6.2018. | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 11.6.2018. |
| 7.6.2018. | Vosevi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/17/1223 | 11.6.2018. |
| 7.6.2018. | Votubia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/710 | 11.6.2018. |
| 7.6.2018. | Xultophy | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/14/947 | 11.6.2018. |
| 7.6.2018. | Zydelig | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/938 | 11.6.2018. |
| 7.6.2018. | Zykadia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/999 | 11.6.2018. |
| 12.6.2018. | Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1133 | 14.6.2018. |
| 12.6.2018. | Fareston | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/96/004 | 14.6.2018. |
| 12.6.2018. | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 14.6.2018. |
| 12.6.2018. | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 14.6.2018. |
| 14.6.2018. | Insuman | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/97/030 | 19.6.2018. |
| 14.6.2018. | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/98/070 | 19.6.2018. |
| 14.6.2018. | SOLYMBIC | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1163 | 19.6.2018. |
| 15.6.2018. | Aerinaze | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/399 | 19.6.2018. |
| 15.6.2018. | Lusduna | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1162 | 19.6.2018. |
| 15.6.2018. | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 19.6.2018. |
| 15.6.2018. | Neoclarityn | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/161 | 19.6.2018. |
| 15.6.2018. | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/312 | 19.6.2018. |
| 15.6.2018. | Zepatier | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1119 | 19.6.2018. |
| 15.6.2018. | Zerbaxa | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1032 | 19.6.2018. |
| 15.6.2018. | ZINPLAVA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1156 | 19.6.2018. |
| 21.6.2018. | Inflectra | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/13/854 | 25.6.2018. |
| 21.6.2018. | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 25.6.2018. |
| 21.6.2018. | Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/10/637 | 25.6.2018. |
| 21.6.2018. | Panretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/149 | 25.6.2018. |
| 21.6.2018. | Remsima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/13/853 | 25.6.2018. |
| 21.6.2018. | Rolufta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | 25.6.2018. |
| 21.6.2018. | Targretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/01/178 | 25.6.2018. |
| 21.6.2018. | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 25.6.2018. |
| 21.6.2018. | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 25.6.2018. |
| 25.6.2018. | Copalia HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/575 | 27.6.2018. |
| 25.6.2018. | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 27.6.2018. |
| 25.6.2018. | Dafiro HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/574 | 27.6.2018. |
| 25.6.2018. | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/16/1101 | 27.6.2018. |
| 25.6.2018. | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 27.6.2018. |
| 25.6.2018. | Exforge | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/370 | 27.6.2018. |
| 25.6.2018. | Glivec | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/198 | 27.6.2018. |
| 25.6.2018. | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/09/604 | 27.6.2018. |
| 25.6.2018. | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 27.6.2018. |
| 25.6.2018. | Orbactiv | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/15/989 | 27.6.2018. |
| 25.6.2018. | PANTOLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/519 | 27.6.2018. |
| 25.6.2018. | Pantoprazole | | | 26.6.2018. |
| 25.6.2018. | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 27.6.2018. |
| 25.6.2018. | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 27.6.2018. |
| 25.6.2018. | Xgeva | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/11/703 | 27.6.2018. |
| 25.6.2018. | Yondelis | Pharma Mar S.A.
  Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 27.6.2018. |
| 29.6.2018. | Aerius | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/160 | 3.7.2018. |
| 29.6.2018. | Azomyr | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/157 | 3.7.2018. |
| 29.6.2018. | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 3.7.2018. |
| 29.6.2018. | Efficib | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/457 | 3.7.2018. |
| 29.6.2018. | Granupas | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/13/896 | 3.7.2018. |
| 29.6.2018. | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 3.7.2018. |
| 29.6.2018. | Janumet | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/455 | 3.7.2018. |
| 29.6.2018. | Jinarc | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | 3.7.2018. |
| 29.6.2018. | Olumiant | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1170 | 3.7.2018. |
| 29.6.2018. | Orgalutran | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/130 | 3.7.2018. |
| 29.6.2018. | Revlimid | Celgene Europe B.V.
  Winthonlaan 6N, 3526 KV Utrecht, Nederland | EU/1/07/391 | 3.7.2018. |
| 29.6.2018. | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 3.7.2018. |
| 29.6.2018. | Ristfor | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/10/620 | 3.7.2018. |
| 29.6.2018. | Samsca | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/09/539 | 3.7.2018. |
| 29.6.2018. | Spectrila | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/15/1072 | 3.7.2018. |
| 29.6.2018. | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 3.7.2018. |
| 29.6.2018. | Velmetia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/456 | 3.7.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.6.2018.

Copalia

Novartis Europharm Limited

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

EU/1/06/372

6.6.2018.

4.6.2018.

Emtriva

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/261

6.6.2018.

4.6.2018.

Iclusig

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

6.6.2018.

4.6.2018.

Prolia

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

6.6.2018.

4.6.2018.

Stocrin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

6.6.2018.

4.6.2018.

Stribild

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/830

6.6.2018.

4.6.2018.

Truvada

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

6.6.2018.

4.6.2018.

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

6.6.2018.

4.6.2018.

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

6.6.2018.

7.6.2018.

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

11.6.2018.

7.6.2018.

BeneFIX

Pfizer Limited

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

EU/1/97/047

11.6.2018.

7.6.2018.

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

11.6.2018.

7.6.2018.

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/14/974

11.6.2018.

7.6.2018.

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

11.6.2018.

7.6.2018.

Constella

Allergan Pharmaceuticals International Limited

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

EU/1/12/801

11.6.2018.

7.6.2018.

Dafiro

Novartis Europharm Limited

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

EU/1/06/371

11.6.2018.

7.6.2018.

Exforge HCT

Novartis Europharm Limited

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

EU/1/09/569

11.6.2018.

7.6.2018.

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

11.6.2018.

7.6.2018.

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

11.6.2018.

7.6.2018.

Isentress

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/436

11.6.2018.

7.6.2018.

Pemetrexed Accord

Accord Healthcare Limited

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

EU/1/15/1071

11.6.2018.

7.6.2018.

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

11.6.2018.

7.6.2018.

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/973

11.6.2018.

7.6.2018.

SomaKit TOC

Advanced Accelerator Applications

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

EU/1/16/1141

11.6.2018.

7.6.2018.

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

11.6.2018.

7.6.2018.

Uptravi

Actelion Registration Ltd

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

EU/1/15/1083

11.6.2018.

7.6.2018.

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

11.6.2018.

7.6.2018.

Vosevi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

11.6.2018.

7.6.2018.

Votubia

Novartis Europharm Limited

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

EU/1/11/710

11.6.2018.

7.6.2018.

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

11.6.2018.

7.6.2018.

Zydelig

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/938

11.6.2018.

7.6.2018.

Zykadia

Novartis Europharm Limited

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

EU/1/15/999

11.6.2018.

12.6.2018.

Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1133

14.6.2018.

12.6.2018.

Fareston

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

14.6.2018.

12.6.2018.

Incruse

Glaxo Group Ltd

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

EU/1/14/922

14.6.2018.

12.6.2018.

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

14.6.2018.

14.6.2018.

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

19.6.2018.

14.6.2018.

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/070

19.6.2018.

14.6.2018.

SOLYMBIC

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1163

19.6.2018.

15.6.2018.

Aerinaze

Merck Sharp & Dohme Limited

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

EU/1/07/399

19.6.2018.

15.6.2018.

Lusduna

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1162

19.6.2018.

15.6.2018.

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

19.6.2018.

15.6.2018.

Neoclarityn

Merck Sharp & Dohme Limited

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

EU/1/00/161

19.6.2018.

15.6.2018.

Xyrem

UCB Pharma S.A.

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

EU/1/05/312

19.6.2018.

15.6.2018.

Zepatier

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1119

19.6.2018.

15.6.2018.

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

19.6.2018.

15.6.2018.

ZINPLAVA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1156

19.6.2018.

21.6.2018.

Inflectra

Hospira UK Limited

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

EU/1/13/854

25.6.2018.

21.6.2018.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

25.6.2018.

21.6.2018.

Leflunomide medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/10/637

25.6.2018.

21.6.2018.

Panretin

Eisai Limited

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

EU/1/00/149

25.6.2018.

21.6.2018.

Remsima

Celltrion Healthcare Hungary Kft.

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

EU/1/13/853

25.6.2018.

21.6.2018.

Rolufta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

25.6.2018.

21.6.2018.

Targretin

Eisai Limited

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

EU/1/01/178

25.6.2018.

21.6.2018.

Xeljanz

Pfizer Limited

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

EU/1/17/1178

25.6.2018.

21.6.2018.

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

25.6.2018.

25.6.2018.

Copalia HCT

Novartis Europharm Limited

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

EU/1/09/575

27.6.2018.

25.6.2018.

Cubicin

Merck Sharp & Dohme Limited

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

EU/1/05/328

27.6.2018.

25.6.2018.

Dafiro HCT

Novartis Europharm Limited

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

EU/1/09/574

27.6.2018.

25.6.2018.

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

27.6.2018.

25.6.2018.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

27.6.2018.

25.6.2018.

Exforge

Novartis Europharm Limited

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

EU/1/06/370

27.6.2018.

25.6.2018.

Glivec

Novartis Europharm Limited

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

EU/1/01/198

27.6.2018.

25.6.2018.

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604

27.6.2018.

25.6.2018.

Nexium Control

Pfizer Consumer Healthcare Limited

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

EU/1/13/860

27.6.2018.

25.6.2018.

Orbactiv

The Medicines Company UK Ltd

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

EU/1/15/989

27.6.2018.

25.6.2018.

PANTOLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/519

27.6.2018.

25.6.2018.

Pantoprazole

26.6.2018.

25.6.2018.

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

27.6.2018.

25.6.2018.

Xeljanz

Pfizer Limited

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

EU/1/17/1178

27.6.2018.

25.6.2018.

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

27.6.2018.

25.6.2018.

Yondelis

Pharma Mar S.A.

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

EU/1/07/417

27.6.2018.

29.6.2018.

Aerius

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/160

3.7.2018.

29.6.2018.

Azomyr

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/157

3.7.2018.

29.6.2018.

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

3.7.2018.

29.6.2018.

Efficib

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/457

3.7.2018.

29.6.2018.

Granupas

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/896

3.7.2018.

29.6.2018.

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

3.7.2018.

29.6.2018.

Janumet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/455

3.7.2018.

29.6.2018.

Jinarc

Otsuka Pharmaceutical Europe Ltd

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

EU/1/15/1000

3.7.2018.

29.6.2018.

Olumiant

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

3.7.2018.

29.6.2018.

Orgalutran

Merck Sharp & Dohme Limited

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

EU/1/00/130

3.7.2018.

29.6.2018.

Revlimid

Celgene Europe B.V.

Winthonlaan 6N, 3526 KV Utrecht, Nederland

EU/1/07/391

3.7.2018.

29.6.2018.

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

3.7.2018.

29.6.2018.

Ristfor

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/620

3.7.2018.

29.6.2018.

Samsca

Otsuka Pharmaceutical Europe Ltd

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

EU/1/09/539

3.7.2018.

29.6.2018.

Spectrila

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1072

3.7.2018.

29.6.2018.

Temozolomide Accord

Accord Healthcare Limited

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

EU/1/10/615

3.7.2018.

29.6.2018.

Velmetia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/456

3.7.2018.

| — | Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants) |
| --- | --- |

—

Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 15.6.2018. | SOLYMBIC | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1163 | 19.6.2018. |
| 21.6.2018. | Angiox | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/04/289 | 25.6.2018. |
| 29.6.2018. | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 3.7.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

15.6.2018.

SOLYMBIC

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1163

19.6.2018.

21.6.2018.

Angiox

The Medicines Company UK Ltd

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

EU/1/04/289

25.6.2018.

29.6.2018.

Victrelis

Merck Sharp & Dohme Limited

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

EU/1/11/704

3.7.2018.

| — | Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas |
| --- | --- |

—

Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.6.2018. | Dany's BienenWohl | skābeņskābes dihidrāts | Dany Bienenwohl GmbH
  Geyerspergerstraße 27, 80689 München, Deutschland | EU/2/18/225 | Pulveris un šķīdums dispersijai lietošanai bišu stropā | QP53AG03 | 19.6.2018. |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

14.6.2018.

Dany's BienenWohl

skābeņskābes dihidrāts

Dany Bienenwohl GmbH

Geyerspergerstraße 27, 80689 München, Deutschland

EU/2/18/225

Pulveris un šķīdums dispersijai lietošanai bišu stropā

QP53AG03

19.6.2018.

| — | Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas |
| --- | --- |

—

Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 4.6.2018. | Activyl | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/10/118 | 6.6.2018. |
| 4.6.2018. | Cepedex | CP-Pharma Handelsgesellschaft mbH
  Ostlandring 13, 31303 Burgdorf, Deutschland | EU/2/16/200 | 6.6.2018. |
| 11.6.2018. | Veraflox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/10/107 | 13.6.2018. |
| 14.6.2018. | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/153 | 19.6.2018. |
| 18.6.2018. | Rhiniseng | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/10/109 | 20.6.2018. |
| 27.6.2018. | BROADLINE | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/157 | 29.6.2018. |
| 27.6.2018. | Evalon | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/16/194 | 29.6.2018. |
| 27.6.2018. | Porcilis PCV M Hyo | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/14/175 | 29.6.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.6.2018.

Activyl

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/118

6.6.2018.

4.6.2018.

Cepedex

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/16/200

6.6.2018.

11.6.2018.

Veraflox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/10/107

13.6.2018.

14.6.2018.

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/153

19.6.2018.

18.6.2018.

Rhiniseng

Laboratorios Hipra, S.A.

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

EU/2/10/109

20.6.2018.

27.6.2018.

BROADLINE

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/157

29.6.2018.

27.6.2018.

Evalon

Laboratorios Hipra, S.A.

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

EU/2/16/194

29.6.2018.

27.6.2018.

Porcilis PCV M Hyo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

29.6.2018.

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

| 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)  OV L 136, 30.4.2004., 1. lpp.

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