# Eiropas Savienības C 211/2015

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 211 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 58. sējums2015. gada 26. jūnijs |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 211

Izdevums latviešu valodā

Informācija un paziņojumi

58. sējums2015. gada 26. jūnijs

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| Paziņojums Nr. | Saturs | Lappuse |
| --- | --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2015/C 211/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. maija līdz 2015. gada 31. maijam(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu) | 1 |

Paziņojums Nr.

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2015/C 211/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. maija līdz 2015. gada 31. maijam(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

| 26.6.2015 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 211/1 |
| --- | --- | --- | --- |

26.6.2015

LV

Eiropas Savienības Oficiālais Vēstnesis

C 211/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. maija līdz 2015. gada 31. maijam

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

(2015/C 211/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.5.2015. | Zykadia | ceritiniba | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | Cietās kapsulas | L01XE | 8.5.2015. |
| 27.5.2015. | Akynzeo | Netupitant/Palonosetron | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/15/1001 | Cietās kapsulas | A04AA55 | 29.5.2015. |
| 27.5.2015. | Jinarc | tolvaptan | Otsuka Pharmaceutical Europe Ltd.
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | Tabletes | Pending | 29.5.2015. |
| 27.5.2015. | Synjardy | empagliflozīns/metformīns | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | Apvalkotās tabletes | A10BD20 | 29.5.2015. |
| 27.5.2015. | Voriconazole Hospira | Voriconazole | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/15/1004 | Pulveris infūziju šķīduma pagatavošanai | J02AC03 | 29.5.2015. |
| 28.5.2015. | Lenvima | lenvatinib | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/15/1002 | Cietās kapsulas | L01XE29 | 1.6.2015. |

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

6.5.2015.

Zykadia

ceritiniba

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

Cietās kapsulas

L01XE

8.5.2015.

27.5.2015.

Akynzeo

Netupitant/Palonosetron

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/15/1001

Cietās kapsulas

A04AA55

29.5.2015.

27.5.2015.

Jinarc

tolvaptan

Otsuka Pharmaceutical Europe Ltd.

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

EU/1/15/1000

Tabletes

Pending

29.5.2015.

27.5.2015.

Synjardy

empagliflozīns/metformīns

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

Apvalkotās tabletes

A10BD20

29.5.2015.

27.5.2015.

Voriconazole Hospira

Voriconazole

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/15/1004

Pulveris infūziju šķīduma pagatavošanai

J02AC03

29.5.2015.

28.5.2015.

Lenvima

lenvatinib

Eisai Europe Limited

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

EU/1/15/1002

Cietās kapsulas

L01XE29

1.6.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 5.5.2015. | Copalia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/372 | 7.5.2015. |
| 5.5.2015. | Copalia HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/575 | 7.5.2015. |
| 5.5.2015. | Dafiro | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/371 | 7.5.2015. |
| 5.5.2015. | Dafiro HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/574 | 7.5.2015. |
| 5.5.2015. | Erivedge | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | 8.5.2015. |
| 5.5.2015. | Exforge | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/370 | 7.5.2015. |
| 5.5.2015. | Exforge HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/569 | 7.5.2015. |
| 5.5.2015. | Imprida | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/373 | 7.5.2015. |
| 5.5.2015. | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 7.5.2015. |
| 5.5.2015. | Irbesartan/Hydrochlorothiazide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/583 | 8.5.2015. |
| 5.5.2015. | Orfadin | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | EU/1/04/303 | 8.5.2015. |
| 5.5.2015. | Sycrest | Organon N.V.
  Kloosterstraat 6, NL-5349 AB Oss, Nederland | EU/1/10/640 | 7.5.2015. |
| 5.5.2015. | Tamiflu | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222 | 8.5.2015. |
| 5.5.2015. | Telzir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/282 | 7.5.2015. |
| 5.5.2015. | Tyverb | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/440 | 7.5.2015. |
| 5.5.2015. | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/13/857 | 7.5.2015. |
| 5.5.2015. | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 7.5.2015. |
| 5.5.2015. | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 7.5.2015. |
| 5.5.2015. | Zypadhera | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/08/479 | 7.5.2015. |
| 6.5.2015. | Arzerra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/625 | 8.5.2015. |
| 6.5.2015. | Celsentri | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/07/418 | 8.5.2015. |
| 6.5.2015. | Celvapan | Baxter AG
  Industriestraße 67, A-1221 Wien, Österreich | EU/1/08/506 | 8.5.2015. |
| 6.5.2015. | Clopidogrel Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/556 | 8.5.2015. |
| 6.5.2015. | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 8.5.2015. |
| 6.5.2015. | Optaflu | Novartis Influenza Vaccines Marburg GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 8.5.2015. |
| 6.5.2015. | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 8.5.2015. |
| 6.5.2015. | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 8.5.2015. |
| 13.5.2015. | Cayston | Gilead Sciences International Limited
  Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543 | 19.5.2015. |
| 13.5.2015. | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 19.5.2015. |
| 13.5.2015. | Granupas | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/896 | 19.5.2015. |
| 13.5.2015. | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 19.5.2015. |
| 13.5.2015. | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/10/654 | 19.5.2015. |
| 13.5.2015. | Luminity | Lantheus MI UK Limited
  Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom | EU/1/06/361 | 19.5.2015. |
| 13.5.2015. | Memantine Merz | Merz Pharmaceuticals GmbH
  Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland | EU/1/12/799 | 19.5.2015. |
| 13.5.2015. | Ovitrelle | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/165 | 19.5.2015. |
| 13.5.2015. | Trizivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/00/156 | 19.5.2015. |
| 13.5.2015. | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 19.5.2015. |
| 13.5.2015. | Vyndaqel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/11/717 | 19.5.2015. |
| 27.5.2015. | Aflunov | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/658 | 29.5.2015. |
| 27.5.2015. | Ariclaim | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/283 | 29.5.2015. |
| 27.5.2015. | Brinavess | Cardiome UK Limited
  Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | EU/1/10/645 | 29.5.2015. |
| 27.5.2015. | Clopidogrel TAD | TAD Pharma GmbH
  Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland | EU/1/09/555 | 29.5.2015. |
| 27.5.2015. | Cometriq | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/13/890 | 29.5.2015. |
| 27.5.2015. | Cymbalta | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/296 | 29.5.2015. |
| 27.5.2015. | Erivedge | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | 29.5.2015. |
| 27.5.2015. | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/12/750 | 29.5.2015. |
| 27.5.2015. | Foclivia | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/09/577 | 29.5.2015. |
| 27.5.2015. | Gardasil | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 29.5.2015. |
| 27.5.2015. | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 29.5.2015. |
| 27.5.2015. | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 29.5.2015. |
| 27.5.2015. | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 29.5.2015. |
| 27.5.2015. | Levemir | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278 | 29.5.2015. |
| 27.5.2015. | Levetiracetam Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/712 | 29.5.2015. |
| 27.5.2015. | Myclausen | Herbert J. Passauer GmbH & Co. KG
  Stubenrauchstrasse 33, D-14167 Berlin, Deutschland | EU/1/10/647 | 29.5.2015. |
| 27.5.2015. | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 29.5.2015. |
| 27.5.2015. | Nivestim | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/631 | 29.5.2015. |
| 27.5.2015. | Prepandrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/08/453 | 29.5.2015. |
| 27.5.2015. | Raloxifene Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/627 | 29.6.2015. |
| 27.5.2015. | Relistor | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/08/463 | 29.5.2015. |
| 27.5.2015. | Resolor | Shire Pharmaceuticals Ireland Limited
  5 River Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/09/581 | 29.5.2015. |
| 27.5.2015. | Selincro | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/12/815 | 29.5.2015. |
| 27.5.2015. | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 29.5.2015. |
| 27.5.2015. | Sonata | Meda AB
  Pipers väg 2A, S-170 09 Solna, Sverige | EU/1/99/102 | 29.5.2015. |
| 27.5.2015. | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 29.5.2015. |
| 27.5.2015. | Targretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/01/178 | 29.5.2015. |
| 27.5.2015. | Temodal | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/98/096 | 29.5.2015. |
| 27.5.2015. | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 29.5.2015. |
| 27.5.2015. | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 29.5.2015. |
| 27.5.2015. | Tolucombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 29.5.2015. |
| 27.5.2015. | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/08/451 | 29.5.2015. |
| 27.5.2015. | Xeristar | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/297 | 29.5.2015. |
| 27.5.2015. | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 29.5.2015. |
| 27.5.2015. | Yentreve | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/280 | 29.5.2015. |
| 27.5.2015. | Yondelis | Pharma Mar S.A.
  Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 29.5.2015. |
| 28.5.2015. | Aclasta | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/308 | 1.6.2015. |
| 28.5.2015. | alli | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/401 | 1.6.2015. |
| 28.5.2015. | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/11/733 | 1.6.2015. |
| 28.5.2015. | Invega | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/07/395 | 1.6.2015. |
| 28.5.2015. | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 1.6.2015. |
| 28.5.2015. | Lonquex | UAB “Sicor Biotech”
  Molėtų pl. 5, LT-08409 Vilnius, Lietuva | EU/1/13/856 | 1.6.2015. |
| 28.5.2015. | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 1.6.2015. |
| 28.5.2015. | Topotecan Hospira | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/633 | 1.6.2015. |
| 28.5.2015. | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 1.6.2015. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

5.5.2015.

Copalia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/372

7.5.2015.

5.5.2015.

Copalia HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/575

7.5.2015.

5.5.2015.

Dafiro

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/371

7.5.2015.

5.5.2015.

Dafiro HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/574

7.5.2015.

5.5.2015.

Erivedge

Roche Registration Limited

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

EU/1/13/848

8.5.2015.

5.5.2015.

Exforge

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/370

7.5.2015.

5.5.2015.

Exforge HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/569

7.5.2015.

5.5.2015.

Imprida

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/373

7.5.2015.

5.5.2015.

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

7.5.2015.

5.5.2015.

Irbesartan/Hydrochlorothiazide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

8.5.2015.

5.5.2015.

Orfadin

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/04/303

8.5.2015.

5.5.2015.

Sycrest

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

EU/1/10/640

7.5.2015.

5.5.2015.

Tamiflu

Roche Registration Limited

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

EU/1/02/222

8.5.2015.

5.5.2015.

Telzir

ViiV Healthcare UK Limited

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

EU/1/04/282

7.5.2015.

5.5.2015.

Tyverb

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/440

7.5.2015.

5.5.2015.

Voncento

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/13/857

7.5.2015.

5.5.2015.

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

7.5.2015.

5.5.2015.

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/772

7.5.2015.

5.5.2015.

Zypadhera

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/479

7.5.2015.

6.5.2015.

Arzerra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/625

8.5.2015.

6.5.2015.

Celsentri

ViiV Healthcare UK Limited

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

EU/1/07/418

8.5.2015.

6.5.2015.

Celvapan

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/08/506

8.5.2015.

6.5.2015.

Clopidogrel Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

8.5.2015.

6.5.2015.

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

8.5.2015.

6.5.2015.

Optaflu

Novartis Influenza Vaccines Marburg GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/07/394

8.5.2015.

6.5.2015.

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

8.5.2015.

6.5.2015.

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

8.5.2015.

13.5.2015.

Cayston

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543

19.5.2015.

13.5.2015.

Efficib

Merck Sharp & Dohme Limited

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

EU/1/08/457

19.5.2015.

13.5.2015.

Granupas

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/896

19.5.2015.

13.5.2015.

Janumet

Merck Sharp & Dohme Limited

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

EU/1/08/455

19.5.2015.

13.5.2015.

Leflunomide ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/10/654

19.5.2015.

13.5.2015.

Luminity

Lantheus MI UK Limited

Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom

EU/1/06/361

19.5.2015.

13.5.2015.

Memantine Merz

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/12/799

19.5.2015.

13.5.2015.

Ovitrelle

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/165

19.5.2015.

13.5.2015.

Trizivir

ViiV Healthcare UK Limited

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

EU/1/00/156

19.5.2015.

13.5.2015.

Velmetia

Merck Sharp & Dohme Limited

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

EU/1/08/456

19.5.2015.

13.5.2015.

Vyndaqel

Pfizer Limited

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

EU/1/11/717

19.5.2015.

27.5.2015.

Aflunov

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/658

29.5.2015.

27.5.2015.

Ariclaim

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/283

29.5.2015.

27.5.2015.

Brinavess

Cardiome UK Limited

Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom

EU/1/10/645

29.5.2015.

27.5.2015.

Clopidogrel TAD

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland

EU/1/09/555

29.5.2015.

27.5.2015.

Cometriq

TMC Pharma Services Ltd

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/13/890

29.5.2015.

27.5.2015.

Cymbalta

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/296

29.5.2015.

27.5.2015.

Erivedge

Roche Registration Limited

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

EU/1/13/848

29.5.2015.

27.5.2015.

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., H-1103 Budapest, Magyarország

EU/1/12/750

29.5.2015.

27.5.2015.

Foclivia

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/09/577

29.5.2015.

27.5.2015.

Gardasil

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

29.5.2015.

27.5.2015.

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

29.5.2015.

27.5.2015.

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

29.5.2015.

27.5.2015.

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

29.5.2015.

27.5.2015.

Levemir

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278

29.5.2015.

27.5.2015.

Levetiracetam Accord

Accord Healthcare Limited

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

EU/1/11/712

29.5.2015.

27.5.2015.

Myclausen

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33, D-14167 Berlin, Deutschland

EU/1/10/647

29.5.2015.

27.5.2015.

Nexium Control

Pfizer Consumer Healthcare Limited

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

EU/1/13/860

29.5.2015.

27.5.2015.

Nivestim

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/631

29.5.2015.

27.5.2015.

Prepandrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/08/453

29.5.2015.

27.5.2015.

Raloxifene Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/627

29.6.2015.

27.5.2015.

Relistor

TMC Pharma Services Ltd

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/08/463

29.5.2015.

27.5.2015.

Resolor

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/09/581

29.5.2015.

27.5.2015.

Selincro

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/12/815

29.5.2015.

27.5.2015.

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

29.5.2015.

27.5.2015.

Sonata

Meda AB

Pipers väg 2A, S-170 09 Solna, Sverige

EU/1/99/102

29.5.2015.

27.5.2015.

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/894

29.5.2015.

27.5.2015.

Targretin

Eisai Limited

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

EU/1/01/178

29.5.2015.

27.5.2015.

Temodal

Merck Sharp & Dohme Limited

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

EU/1/98/096

29.5.2015.

27.5.2015.

Temozolomide Accord

Accord Healthcare Limited

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

EU/1/10/615

29.5.2015.

27.5.2015.

Thalidomide Celgene

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/08/443

29.5.2015.

27.5.2015.

Tolucombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

29.5.2015.

27.5.2015.

Volibris

Glaxo Group Ltd

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

EU/1/08/451

29.5.2015.

27.5.2015.

Xeristar

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/297

29.5.2015.

27.5.2015.

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

29.5.2015.

27.5.2015.

Yentreve

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/280

29.5.2015.

27.5.2015.

Yondelis

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

29.5.2015.

28.5.2015.

Aclasta

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/308

1.6.2015.

28.5.2015.

alli

Glaxo Group Ltd

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

EU/1/07/401

1.6.2015.

28.5.2015.

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/11/733

1.6.2015.

28.5.2015.

Invega

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/07/395

1.6.2015.

28.5.2015.

Januvia

Merck Sharp & Dohme Limited

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

EU/1/07/383

1.6.2015.

28.5.2015.

Lonquex

UAB “Sicor Biotech”

Molėtų pl. 5, LT-08409 Vilnius, Lietuva

EU/1/13/856

1.6.2015.

28.5.2015.

Ristaben

Merck Sharp & Dohme Limited

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

EU/1/10/621

1.6.2015.

28.5.2015.

Topotecan Hospira

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/633

1.6.2015.

28.5.2015.

Tygacil

Pfizer Limited

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

EU/1/06/336

1.6.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 5.5.2015. | Clopidogrel DURA | Mylan dura GmbH
  Wittichstraße 6, D-64295 Darmstadt, Deutschland | EU/1/09/560 | 7.5.2015. |
| 6.5.2015. | Provenge | Dendreon UK Limited
  41 Chalton Street, London NW1 1JD, United Kingdom | EU/1/13/867 | 8.5.2015. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

5.5.2015.

Clopidogrel DURA

Mylan dura GmbH

Wittichstraße 6, D-64295 Darmstadt, Deutschland

EU/1/09/560

7.5.2015.

6.5.2015.

Provenge

Dendreon UK Limited

41 Chalton Street, London NW1 1JD, United Kingdom

EU/1/13/867

8.5.2015.

—   Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 5.5.2015. | MS-H Vaccine | Pharmsure International Ltd
  Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom | EU/2/11/126 | 7.5.2015. |
| 5.5.2015. | Purevax RCP | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/052 | 7.5.2015. |
| 13.5.2015. | Nobilis IB 4-91 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/98/006 | 19.5.2015. |
| 13.5.2015. | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/07/078 | 19.5.2015. |
| 27.5.2015. | Meloxivet | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/07/077 | 29.5.2015. |
| 27.5.2015. | Purevax FeLV | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/00/019 | 29.5.2015. |
| 27.5.2015. | Purevax RCPCh | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/050 | 29.5.2015. |
| 27.5.2015. | Suprelorin | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France | EU/2/07/072 | 29.5.2015. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

5.5.2015.

MS-H Vaccine

Pharmsure International Ltd

Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom

EU/2/11/126

7.5.2015.

5.5.2015.

Purevax RCP

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/052

7.5.2015.

13.5.2015.

Nobilis IB 4-91

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/98/006

19.5.2015.

13.5.2015.

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

19.5.2015.

27.5.2015.

Meloxivet

Eli Lilly and Company Limited

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

EU/2/07/077

29.5.2015.

27.5.2015.

Purevax FeLV

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/00/019

29.5.2015.

27.5.2015.

Purevax RCPCh

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/050

29.5.2015.

27.5.2015.

Suprelorin

VIRBAC S.A.

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

EU/2/07/072

29.5.2015.

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

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK – LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK – LONDON E14 5EU

---

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

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