# Eiropas Savienības C 30/2018

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 30 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 61. gadagājums2018. gada 26. janvāris |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 30

Izdevums latviešu valodā

Informācija un paziņojumi

61. gadagājums2018. gada 26. janvāris

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| Paziņojums Nr. | Saturs | Lappuse |
| --- | --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2018/C 30/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2017. gada 1. decembra līdz 2017. gada 31. decembrim(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu) | 1 |
| 2018/C 30/02 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2017. gada 1. decembra līdz 2017. gada 31. decembrim(Lēmumi pieņemti saskaņā ar Direktīvas 2001/83/EK 34. pantu vai Direktīvas 2001/82/EK 38. pantu) | 10 |

Paziņojums Nr.

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2018/C 30/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2017. gada 1. decembra līdz 2017. gada 31. decembrim(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

2018/C 30/02

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2017. gada 1. decembra līdz 2017. gada 31. decembrim(Lēmumi pieņemti saskaņā ar Direktīvas 2001/83/EK 34. pantu vai Direktīvas 2001/82/EK 38. pantu)

(Lēmumi pieņemti saskaņā ar Direktīvas 2001/83/EK 34. pantu vai Direktīvas 2001/82/EK 38. pantu)

10

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

LV

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IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

| 26.1.2018 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 30/1 |
| --- | --- | --- | --- |

26.1.2018

LV

Eiropas Savienības Oficiālais Vēstnesis

C 30/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2017. gada 1. decembra līdz 2017. gada 31. decembrim

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

(2018/C 030/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.12.2017. | Tacforius | Tacrolimusum | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/17/1244 | Ilgstošās darbības cietās kapsulas | L04AD02 | 12.12.2017. |
| 18.12.2017. | Alecensa | alektinibs | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/16/1169 | Cietās kapsulas | L01XE36 | 20.12.2017. |

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

8.12.2017.

Tacforius

Tacrolimusum

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1244

Ilgstošās darbības cietās kapsulas

L04AD02

12.12.2017.

18.12.2017.

Alecensa

alektinibs

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/16/1169

Cietās kapsulas

L01XE36

20.12.2017.

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

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 8.12.2017. | Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech | XBiotech Germany GmbH
  Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland | — | 12.12.2017. |
| 18.12.2017. | Masipro | AB Science
  3 avenue George V, 75008 Paris, France | — | 20.12.2017. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

8.12.2017.

Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech

XBiotech Germany GmbH

Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland

—

12.12.2017.

18.12.2017.

Masipro

AB Science

3 avenue George V, 75008 Paris, France

—

20.12.2017.

—   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 |
| --- | --- | --- | --- | --- |
| 1.12.2017. | Alecensa | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/16/1169 | 5.12.2017. |
| 1.12.2017. | Hetlioz | Vanda Pharmaceuticals Limited
  25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom | EU/1/15/1008 | 5.12.2017. |
| 1.12.2017. | Jakavi | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/773 | 5.12.2017. |
| 1.12.2017. | OCALIVA | Intercept Pharma Ltd
  2 Pancras Square, London N1C 4AG, United Kingdom | EU/1/16/1139 | 5.12.2017. |
| 1.12.2017. | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498 | 5.12.2017. |
| 8.12.2017. | Ceplene | Noventia Pharma Srl
  Via Carlo Pisacane 31, 47121 Forli, Italia | EU/1/08/477 | 12.12.2017. |
| 8.12.2017. | Dexdor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/718 | 12.12.2017. |
| 8.12.2017. | Esbriet | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/11/667 | 13.12.2017. |
| 8.12.2017. | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/12/750 | 12.12.2017. |
| 8.12.2017. | Genvoya | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/15/1061 | 12.12.2017. |
| 8.12.2017. | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 13.12.2017. |
| 8.12.2017. | Humira | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | EU/1/03/256 | 12.12.2017. |
| 8.12.2017. | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 13.12.2017. |
| 8.12.2017. | JETREA | ThromboGenics NV
  Gaston Geenslaan 1, 3001 Leuven, België | EU/1/13/819 | 12.12.2017. |
| 8.12.2017. | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 13.12.2017. |
| 8.12.2017. | Leganto | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/11/695 | 12.12.2017. |
| 8.12.2017. | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 13.12.2017. |
| 8.12.2017. | Moventig | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/14/962 | 12.12.2017. |
| 8.12.2017. | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 12.12.2017. |
| 8.12.2017. | Oncaspar | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/15/1070 | 14.12.2017. |
| 8.12.2017. | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | 13.12.2017. |
| 8.12.2017. | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/12/815 | 12.12.2017. |
| 8.12.2017. | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 12.12.2017. |
| 8.12.2017. | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 13.12.2017. |
| 8.12.2017. | Truberzi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1126 | 12.12.2017. |
| 8.12.2017. | Xiapex | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/11/671 | 12.12.2017. |
| 8.12.2017. | Zevalin | Spectrum Pharmaceuticals B.V.
  Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland | EU/1/03/264 | 12.12.2017. |
| 11.12.2017. | EVOTAZ | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1025 | 13.12.2017. |
| 11.12.2017. | Holoclar | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/987 | 13.12.2017. |
| 11.12.2017. | Neupro | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/331 | 13.12.2017. |
| 11.12.2017. | Odefsey | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1112 | 13.12.2017. |
| 11.12.2017. | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/10/643 | 15.12.2017. |
| 11.12.2017. | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267 | 13.12.2017. |
| 11.12.2017. | Strensiq | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/15/1015 | 13.12.2017. |
| 11.12.2017. | Tarceva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311 | 13.12.2017. |
| 11.12.2017. | Zyclara | Meda AB
  Pipers väg 2A, 170 73 Solna, Sverige | EU/1/12/783 | 13.12.2017. |
| 15.12.2017. | Actelsar HCT | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/817 | 19.12.2017. |
| 15.12.2017. | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 19.12.2017. |
| 15.12.2017. | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 19.12.2017. |
| 15.12.2017. | Eviplera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/11/737 | 19.12.2017. |
| 15.12.2017. | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 19.12.2017. |
| 15.12.2017. | M-M-RVAXPRO | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/337 | 19.12.2017. |
| 15.12.2017. | Procysbi | Chiesi Orphan B.V.
  Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland | EU/1/13/861 | 19.12.2017. |
| 15.12.2017. | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 19.12.2017. |
| 15.12.2017. | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620 | 19.12.2017. |
| 15.12.2017. | Stocrin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/111 | 19.12.2017. |
| 15.12.2017. | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110 | 19.12.2017. |
| 15.12.2017. | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 19.12.2017. |
| 18.12.2017. | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 20.12.2017. |
| 18.12.2017. | Enbrel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/126 | 20.12.2017. |
| 18.12.2017. | HBVAXPRO | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/01/183 | 20.12.2017. |
| 18.12.2017. | NovoMix | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/00/142 | 20.12.2017. |
| 18.12.2017. | ProQuad | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/05/323 | 20.12.2017. |
| 18.12.2017. | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 20.12.2017. |
| 20.12.2017. | Azilect | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/04/304 | 22.12.2017. |
| 20.12.2017. | Duloxetine Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/972 | 22.12.2017. |
| 20.12.2017. | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1051 | 22.12.2017. |
| 20.12.2017. | Efient | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/08/503 | 22.12.2017. |
| 20.12.2017. | Fabrazyme | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/01/188 | 22.12.2017. |
| 20.12.2017. | Gardasil | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 22.12.2017. |
| 20.12.2017. | Incresync | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/842 | 20.12.2017. |
| 20.12.2017. | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/06/368 | 2.1.2018. |
| 20.12.2017. | Levetiracetam ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/11/702 | 22.12.2017. |
| 20.12.2017. | Levetiracetam SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/741 | 22.12.2017. |
| 20.12.2017. | Qtern | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1108 | 22.12.2017. |
| 20.12.2017. | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/462 | 22.12.2017. |
| 20.12.2017. | Tivicay | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/13/892 | 22.12.2017. |
| 20.12.2017. | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/900 | 22.12.2017. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

1.12.2017.

Alecensa

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/16/1169

5.12.2017.

1.12.2017.

Hetlioz

Vanda Pharmaceuticals Limited

25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom

EU/1/15/1008

5.12.2017.

1.12.2017.

Jakavi

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/773

5.12.2017.

1.12.2017.

OCALIVA

Intercept Pharma Ltd

2 Pancras Square, London N1C 4AG, United Kingdom

EU/1/16/1139

5.12.2017.

1.12.2017.

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

5.12.2017.

8.12.2017.

Ceplene

Noventia Pharma Srl

Via Carlo Pisacane 31, 47121 Forli, Italia

EU/1/08/477

12.12.2017.

8.12.2017.

Dexdor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

12.12.2017.

8.12.2017.

Esbriet

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/11/667

13.12.2017.

8.12.2017.

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

12.12.2017.

8.12.2017.

Genvoya

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/15/1061

12.12.2017.

8.12.2017.

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

13.12.2017.

8.12.2017.

Humira

AbbVie Ltd

Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom

EU/1/03/256

12.12.2017.

8.12.2017.

Januvia

Merck Sharp & Dohme Limited

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

EU/1/07/383

13.12.2017.

8.12.2017.

JETREA

ThromboGenics NV

Gaston Geenslaan 1, 3001 Leuven, België

EU/1/13/819

12.12.2017.

8.12.2017.

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

13.12.2017.

8.12.2017.

Leganto

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

12.12.2017.

8.12.2017.

Lemtrada

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

13.12.2017.

8.12.2017.

Moventig

Kyowa Kirin Limited

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/14/962

12.12.2017.

8.12.2017.

Mysimba

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

12.12.2017.

8.12.2017.

Oncaspar

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/15/1070

14.12.2017.

8.12.2017.

Perjeta

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/813

13.12.2017.

8.12.2017.

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

12.12.2017.

8.12.2017.

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

12.12.2017.

8.12.2017.

Tesavel

Merck Sharp & Dohme Limited

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

EU/1/07/435

13.12.2017.

8.12.2017.

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1126

12.12.2017.

8.12.2017.

Xiapex

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/11/671

12.12.2017.

8.12.2017.

Zevalin

Spectrum Pharmaceuticals B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/03/264

12.12.2017.

11.12.2017.

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1025

13.12.2017.

11.12.2017.

Holoclar

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/987

13.12.2017.

11.12.2017.

Neupro

UCB Pharma S.A.

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

EU/1/05/331

13.12.2017.

11.12.2017.

Odefsey

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1112

13.12.2017.

11.12.2017.

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

15.12.2017.

11.12.2017.

Reyataz

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267

13.12.2017.

11.12.2017.

Strensiq

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/15/1015

13.12.2017.

11.12.2017.

Tarceva

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311

13.12.2017.

11.12.2017.

Zyclara

Meda AB

Pipers väg 2A, 170 73 Solna, Sverige

EU/1/12/783

13.12.2017.

15.12.2017.

Actelsar HCT

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/817

19.12.2017.

15.12.2017.

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

19.12.2017.

15.12.2017.

Efficib

Merck Sharp & Dohme Limited

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

EU/1/08/457

19.12.2017.

15.12.2017.

Eviplera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/11/737

19.12.2017.

15.12.2017.

Janumet

Merck Sharp & Dohme Limited

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

EU/1/08/455

19.12.2017.

15.12.2017.

M-M-RVAXPRO

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/337

19.12.2017.

15.12.2017.

Procysbi

Chiesi Orphan B.V.

Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland

EU/1/13/861

19.12.2017.

15.12.2017.

Ristaben

Merck Sharp & Dohme Limited

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

EU/1/10/621

19.12.2017.

15.12.2017.

Ristfor

Merck Sharp & Dohme Limited

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

EU/1/10/620

19.12.2017.

15.12.2017.

Stocrin

Merck Sharp & Dohme Limited

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

EU/1/99/111

19.12.2017.

15.12.2017.

Sustiva

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/99/110

19.12.2017.

15.12.2017.

Velmetia

Merck Sharp & Dohme Limited

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

EU/1/08/456

19.12.2017.

18.12.2017.

Daklinza

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/14/939

20.12.2017.

18.12.2017.

Enbrel

Pfizer Limited

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

EU/1/99/126

20.12.2017.

18.12.2017.

HBVAXPRO

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/01/183

20.12.2017.

18.12.2017.

NovoMix

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/00/142

20.12.2017.

18.12.2017.

ProQuad

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/05/323

20.12.2017.

18.12.2017.

Xelevia

Merck Sharp & Dohme Limited

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

EU/1/07/382

20.12.2017.

20.12.2017.

Azilect

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/04/304

22.12.2017.

20.12.2017.

Duloxetine Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/972

22.12.2017.

20.12.2017.

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

22.12.2017.

20.12.2017.

Efient

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/08/503

22.12.2017.

20.12.2017.

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/01/188

22.12.2017.

20.12.2017.

Gardasil

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

22.12.2017.

20.12.2017.

Incresync

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/842

20.12.2017.

20.12.2017.

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368

2.1.2018.

20.12.2017.

Levetiracetam ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/702

22.12.2017.

20.12.2017.

Levetiracetam SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/741

22.12.2017.

20.12.2017.

Qtern

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1108

22.12.2017.

20.12.2017.

Ranexa

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/462

22.12.2017.

20.12.2017.

Tivicay

ViiV Healthcare UK Limited

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

EU/1/13/892

22.12.2017.

20.12.2017.

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

22.12.2017.

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.12.2017. | Rabitec | Trakumsērgas vakcīna (dzīva, iekšķīgi lietojama) lapsām un jenotsuņiem | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/17/219 | Suspensija iekšķīgai lietošanai | QI07BD | 5.12.2017. |

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

1.12.2017.

Rabitec

Trakumsērgas vakcīna (dzīva, iekšķīgi lietojama) lapsām un jenotsuņiem

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/17/219

Suspensija iekšķīgai lietošanai

QI07BD

5.12.2017.

—   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 |
| --- | --- | --- | --- | --- |
| 6.12.2017. | Kexxtone | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/12/145 | 8.12.2017. |
| 6.12.2017. | Spironolactone Ceva | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/07/074 | 8.12.2017. |
| 18.12.2017. | Sedadex | Le Vet Beheer B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/16/198 | 20.12.2017. |
| 20.12.2017. | Easotic | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/08/085 | 22.12.2017. |
| 20.12.2017. | Leucogen | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/09/096 | 22.12.2017. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

6.12.2017.

Kexxtone

Eli Lilly and Company Limited

Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/12/145

8.12.2017.

6.12.2017.

Spironolactone Ceva

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/07/074

8.12.2017.

18.12.2017.

Sedadex

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/16/198

20.12.2017.

20.12.2017.

Easotic

VIRBAC S.A.

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/08/085

22.12.2017.

20.12.2017.

Leucogen

Virbac

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/09/096

22.12.2017.

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.

---

| 26.1.2018 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 30/10 |
| --- | --- | --- | --- |

26.1.2018

LV

Eiropas Savienības Oficiālais Vēstnesis

C 30/10

---

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2017. gada 1. decembra līdz 2017. gada 31. decembrim

(Lēmumi pieņemti saskaņā ar Direktīvas 2001/83/EK (1) 34. pantu vai Direktīvas 2001/82/EK (2) 38. pantu)

(2018/C 030/02)

—   Valsts tirdzniecības atļauja atteikta

| Lēmuma datums | Zāļu nosaukums(-i) | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs(-i) | Attiecīgā dalībvalsts | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- |
| 18.12.2017. | Alcover and associated names – Art 29 | Sodium oxybate | — | — | 19.12.2017. |

Lēmuma datums

Zāļu nosaukums(-i)

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs(-i)

Attiecīgā dalībvalsts

Paziņojuma datums

18.12.2017.

Alcover and associated names – Art 29

Sodium oxybate

—

—

19.12.2017.

---

(1)  OV L 311, 28.11.2001., 67. lpp.

(2)  OV L 311, 28.11.2001., 1. lpp.

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