# Europos Sąjungos C 211/2015

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 211 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 58 tomas2015m. birželio 26d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 211

Leidimas lietuvių kalba

Informacija ir pranešimai

58 tomas2015m. birželio 26d.

---

| Pranešimo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2015/C 211/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. gegužės 1 d. iki 2015 m. gegužės 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |

Pranešimo Nr.

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2015/C 211/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. gegužės 1 d. iki 2015 m. gegužės 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

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

1

---

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

LT

---

IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 26.6.2015 | LT | Europos Sąjungos oficialusis leidinys | C 211/1 |
| --- | --- | --- | --- |

26.6.2015

LT

Europos Sąjungos oficialusis leidinys

C 211/1

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. gegužės 1 d. iki 2015 m. gegužės 31 d.

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

(2015/C 211/01)

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

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2015 5 6 | Zykadia | ceritinibas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/15/999 | Kieta kapsulė | L01XE | 2015 5 8 |
| 2015 5 27 | Akynzeo | Netupitantas/palonosetronas | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | ES/1/15/1001 | Kieta kapsulė | A04AA55 | 2015 5 29 |
| 2015 5 27 | Jinarc | tolvaptanas | Otsuka Pharmaceutical Europe Ltd.
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | ES/1/15/1000 | Tabletės | Pending | 2015 5 29 |
| 2015 5 27 | Synjardy | empagliflozino/metformino | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | ES/1/15/1003 | Plėvele dengta tabletė | A10BD20 | 2015 5 29 |
| 2015 5 27 | Voriconazole Hospira | Vorikonazolas | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | ES/1/15/1004 | Milteliai infuziniam tirpalui | J02AC03 | 2015 5 29 |
| 2015 5 28 | Lenvima | Lenvatinibas | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | ES/1/15/1002 | Kieta kapsulė | L01XE29 | 2015 6 1 |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2015 5 6

Zykadia

ceritinibas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/15/999

Kieta kapsulė

L01XE

2015 5 8

2015 5 27

Akynzeo

Netupitantas/palonosetronas

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

ES/1/15/1001

Kieta kapsulė

A04AA55

2015 5 29

2015 5 27

Jinarc

tolvaptanas

Otsuka Pharmaceutical Europe Ltd.

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

ES/1/15/1000

Tabletės

Pending

2015 5 29

2015 5 27

Synjardy

empagliflozino/metformino

Boehringer Ingelheim International GmbH

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

ES/1/15/1003

Plėvele dengta tabletė

A10BD20

2015 5 29

2015 5 27

Voriconazole Hospira

Vorikonazolas

Hospira UK Limited

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

ES/1/15/1004

Milteliai infuziniam tirpalui

J02AC03

2015 5 29

2015 5 28

Lenvima

Lenvatinibas

Eisai Europe Limited

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

ES/1/15/1002

Kieta kapsulė

L01XE29

2015 6 1

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

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 5 5 | Copalia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/06/372 | 2015 5 7 |
| 2015 5 5 | Copalia HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/09/575 | 2015 5 7 |
| 2015 5 5 | Dafiro | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/06/371 | 2015 5 7 |
| 2015 5 5 | Dafiro HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/09/574 | 2015 5 7 |
| 2015 5 5 | Erivedge | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/13/848 | 2015 5 8 |
| 2015 5 5 | Exforge | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/06/370 | 2015 5 7 |
| 2015 5 5 | Exforge HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/09/569 | 2015 5 7 |
| 2015 5 5 | Imprida | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/06/373 | 2015 5 7 |
| 2015 5 5 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | ES/1/07/402 | 2015 5 7 |
| 2015 5 5 | Irbesartan/Hydrochlorothiazide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/09/583 | 2015 5 8 |
| 2015 5 5 | Orfadin | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | ES/1/04/303 | 2015 5 8 |
| 2015 5 5 | Sycrest | Organon N.V.
  Kloosterstraat 6, NL-5349 AB Oss, Nederland | ES/1/10/640 | 2015 5 7 |
| 2015 5 5 | Tamiflu | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/02/222 | 2015 5 8 |
| 2015 5 5 | Telzir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ES/1/04/282 | 2015 5 7 |
| 2015 5 5 | Tyverb | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/07/440 | 2015 5 7 |
| 2015 5 5 | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | ES/1/13/857 | 2015 5 7 |
| 2015 5 5 | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/10/628 | 2015 5 7 |
| 2015 5 5 | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/12/772 | 2015 5 7 |
| 2015 5 5 | Zypadhera | Eli Lilly Nederland B.V.
  Grootslag 1–5, NL-3991 RA Houten, Nederland | ES/1/08/479 | 2015 5 7 |
| 2015 5 6 | Arzerra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/10/625 | 2015 5 8 |
| 2015 5 6 | Celsentri | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ES/1/07/418 | 2015 5 8 |
| 2015 5 6 | Celvapan | Baxter AG
  Industriestraße 67, A-1221 Wien, Österreich | ES/1/08/506 | 2015 5 8 |
| 2015 5 6 | Clopidogrel Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/09/556 | 2015 5 8 |
| 2015 5 6 | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/12/808 | 2015 5 8 |
| 2015 5 6 | Optaflu | Novartis Influenza Vaccines Marburg GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | ES/1/07/394 | 2015 5 8 |
| 2015 5 6 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/10/612 | 2015 5 8 |
| 2015 5 6 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/13/865 | 2015 5 8 |
| 2015 5 13 | Cayston | Gilead Sciences International Limited
  Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | ES/1/09/543 | 2015 5 19 |
| 2015 5 13 | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/08/457 | 2015 5 19 |
| 2015 5 13 | Granupas | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | ES/1/13/896 | 2015 5 19 |
| 2015 5 13 | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/08/455 | 2015 5 19 |
| 2015 5 13 | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ES/1/10/654 | 2015 5 19 |
| 2015 5 13 | Luminity | Lantheus MI UK Limited
  Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom | ES/1/06/361 | 2015 5 19 |
| 2015 5 13 | Memantine Merz | Merz Pharmaceuticals GmbH
  Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland | ES/1/12/799 | 2015 5 19 |
| 2015 5 13 | Ovitrelle | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | ES/1/00/165 | 2015 5 19 |
| 2015 5 13 | Trizivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ES/1/00/156 | 2015 5 19 |
| 2015 5 13 | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/08/456 | 2015 5 19 |
| 2015 5 13 | Vyndaqel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/11/717 | 2015 5 19 |
| 2015 5 27 | Aflunov | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | ES/1/10/658 | 2015 5 29 |
| 2015 5 27 | Ariclaim | Eli Lilly Nederland B.V.
  Grootslag 1–5, NL-3991 RA Houten, Nederland | ES/1/04/283 | 2015 5 29 |
| 2015 5 27 | Brinavess | Cardiome UK Limited
  Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | ES/1/10/645 | 2015 5 29 |
| 2015 5 27 | Clopidogrel TAD | TAD Pharma GmbH
  Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland | ES/1/09/555 | 2015 5 29 |
| 2015 5 27 | Cometriq | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | ES/1/13/890 | 2015 5 29 |
| 2015 5 27 | Cymbalta | Eli Lilly Nederland B.V.
  Grootslag 1–5, NL-3991 RA Houten, Nederland | ES/1/04/296 | 2015 5 29 |
| 2015 5 27 | Erivedge | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/13/848 | 2015 5 29 |
| 2015 5 27 | Esmya | Gedeon Richter Plc.
  Gyömrői út 19–21., H-1103 Budapest, Magyarország | ES/1/12/750 | 2015 5 29 |
| 2015 5 27 | Foclivia | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | ES/1/09/577 | 2015 5 29 |
| 2015 5 27 | Gardasil | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/06/357 | 2015 5 29 |
| 2015 5 27 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | ES/1/13/850 | 2015 5 29 |
| 2015 5 27 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | ES/1/07/402 | 2015 5 29 |
| 2015 5 27 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | ES/1/12/780 | 2015 5 29 |
| 2015 5 27 | Levemir | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | ES/1/04/278 | 2015 5 29 |
| 2015 5 27 | Levetiracetam Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/11/712 | 2015 5 29 |
| 2015 5 27 | Myclausen | Herbert J. Passauer GmbH & Co. KG
  Stubenrauchstrasse 33, D-14167 Berlin, Deutschland | ES/1/10/647 | 2015 5 29 |
| 2015 5 27 | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | ES/1/13/860 | 2015 5 29 |
| 2015 5 27 | Nivestim | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | ES/1/10/631 | 2015 5 29 |
| 2015 5 27 | Prepandrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | ES/1/08/453 | 2015 5 29 |
| 2015 5 27 | Raloxifene Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/10/627 | 2015 6 29 |
| 2015 5 27 | Relistor | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | ES/1/08/463 | 2015 5 29 |
| 2015 5 27 | Resolor | Shire Pharmaceuticals Ireland Limited
  5 River Walk, Citywest Business Campus, Dublin 24, Ireland | ES/1/09/581 | 2015 5 29 |
| 2015 5 27 | Selincro | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | ES/1/12/815 | 2015 5 29 |
| 2015 5 27 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/06/358 | 2015 5 29 |
| 2015 5 27 | Sonata | MEDA AB
  Pipers väg 2A, S-170 09 Solna, Sverige | ES/1/99/102 | 2015 5 29 |
| 2015 5 27 | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/13/894 | 2015 5 29 |
| 2015 5 27 | Targretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | ES/1/01/178 | 2015 5 29 |
| 2015 5 27 | Temodal | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/98/096 | 2015 5 29 |
| 2015 5 27 | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/10/615 | 2015 5 29 |
| 2015 5 27 | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | ES/1/08/443 | 2015 5 29 |
| 2015 5 27 | Tolucombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/13/821 | 2015 5 29 |
| 2015 5 27 | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/08/451 | 2015 5 29 |
| 2015 5 27 | Xeristar | Eli Lilly Nederland B.V.
  Grootslag 1–5, NL-3991 RA Houten, Nederland | ES/1/04/297 | 2015 5 29 |
| 2015 5 27 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | ES/1/13/846 | 2015 5 29 |
| 2015 5 27 | Yentreve | Eli Lilly Nederland B.V.
  Grootslag 1–5, NL-3991 RA Houten, Nederland | ES/1/04/280 | 2015 5 29 |
| 2015 5 27 | Yondelis | Pharma Mar S.A.
  Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | ES/1/07/417 | 2015 5 29 |
| 2015 5 28 | Aclasta | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/05/308 | 2015 6 1 |
| 2015 5 28 | alli | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/07/401 | 2015 6 1 |
| 2015 5 28 | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | ES/1/11/733 | 2015 6 1 |
| 2015 5 28 | Invega | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | ES/1/07/395 | 2015 6 1 |
| 2015 5 28 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/07/383 | 2015 6 1 |
| 2015 5 28 | Lonquex | UAB „Sicor Biotech“
  Molėtų pl. 5, LT-08409 Vilnius, Lietuva | ES/1/13/856 | 2015 6 1 |
| 2015 5 28 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/10/621 | 2015 6 1 |
| 2015 5 28 | Topotecan Hospira | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | ES/1/10/633 | 2015 6 1 |
| 2015 5 28 | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/06/336 | 2015 6 1 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 5 5

Copalia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/06/372

2015 5 7

2015 5 5

Copalia HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/09/575

2015 5 7

2015 5 5

Dafiro

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/06/371

2015 5 7

2015 5 5

Dafiro HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/09/574

2015 5 7

2015 5 5

Erivedge

Roche Registration Limited

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

ES/1/13/848

2015 5 8

2015 5 5

Exforge

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/06/370

2015 5 7

2015 5 5

Exforge HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/09/569

2015 5 7

2015 5 5

Imprida

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/06/373

2015 5 7

2015 5 5

INCRELEX

Ipsen Pharma

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

ES/1/07/402

2015 5 7

2015 5 5

Irbesartan/Hydrochlorothiazide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/09/583

2015 5 8

2015 5 5

Orfadin

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

ES/1/04/303

2015 5 8

2015 5 5

Sycrest

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

ES/1/10/640

2015 5 7

2015 5 5

Tamiflu

Roche Registration Limited

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

ES/1/02/222

2015 5 8

2015 5 5

Telzir

ViiV Healthcare UK Limited

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

ES/1/04/282

2015 5 7

2015 5 5

Tyverb

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/07/440

2015 5 7

2015 5 5

Voncento

CSL Behring GmbH

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

ES/1/13/857

2015 5 7

2015 5 5

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/10/628

2015 5 7

2015 5 5

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/12/772

2015 5 7

2015 5 5

Zypadhera

Eli Lilly Nederland B.V.

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

ES/1/08/479

2015 5 7

2015 5 6

Arzerra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/10/625

2015 5 8

2015 5 6

Celsentri

ViiV Healthcare UK Limited

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

ES/1/07/418

2015 5 8

2015 5 6

Celvapan

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

ES/1/08/506

2015 5 8

2015 5 6

Clopidogrel Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/09/556

2015 5 8

2015 5 6

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/12/808

2015 5 8

2015 5 6

Optaflu

Novartis Influenza Vaccines Marburg GmbH

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

ES/1/07/394

2015 5 8

2015 5 6

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/10/612

2015 5 8

2015 5 6

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/13/865

2015 5 8

2015 5 13

Cayston

Gilead Sciences International Limited

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

ES/1/09/543

2015 5 19

2015 5 13

Efficib

Merck Sharp & Dohme Limited

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

ES/1/08/457

2015 5 19

2015 5 13

Granupas

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

ES/1/13/896

2015 5 19

2015 5 13

Janumet

Merck Sharp & Dohme Limited

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

ES/1/08/455

2015 5 19

2015 5 13

Leflunomide ratiopharm

ratiopharm GmbH

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

ES/1/10/654

2015 5 19

2015 5 13

Luminity

Lantheus MI UK Limited

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

ES/1/06/361

2015 5 19

2015 5 13

Memantine Merz

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

ES/1/12/799

2015 5 19

2015 5 13

Ovitrelle

Merck Serono Europe Limited

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

ES/1/00/165

2015 5 19

2015 5 13

Trizivir

ViiV Healthcare UK Limited

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

ES/1/00/156

2015 5 19

2015 5 13

Velmetia

Merck Sharp & Dohme Limited

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

ES/1/08/456

2015 5 19

2015 5 13

Vyndaqel

Pfizer Limited

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

ES/1/11/717

2015 5 19

2015 5 27

Aflunov

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

ES/1/10/658

2015 5 29

2015 5 27

Ariclaim

Eli Lilly Nederland B.V.

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

ES/1/04/283

2015 5 29

2015 5 27

Brinavess

Cardiome UK Limited

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

ES/1/10/645

2015 5 29

2015 5 27

Clopidogrel TAD

TAD Pharma GmbH

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

ES/1/09/555

2015 5 29

2015 5 27

Cometriq

TMC Pharma Services Ltd

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

ES/1/13/890

2015 5 29

2015 5 27

Cymbalta

Eli Lilly Nederland B.V.

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

ES/1/04/296

2015 5 29

2015 5 27

Erivedge

Roche Registration Limited

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

ES/1/13/848

2015 5 29

2015 5 27

Esmya

Gedeon Richter Plc.

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

ES/1/12/750

2015 5 29

2015 5 27

Foclivia

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

ES/1/09/577

2015 5 29

2015 5 27

Gardasil

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/06/357

2015 5 29

2015 5 27

Imnovid

Celgene Europe Limited

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

ES/1/13/850

2015 5 29

2015 5 27

INCRELEX

Ipsen Pharma

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

ES/1/07/402

2015 5 29

2015 5 27

Jentadueto

Boehringer Ingelheim International GmbH

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

ES/1/12/780

2015 5 29

2015 5 27

Levemir

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

ES/1/04/278

2015 5 29

2015 5 27

Levetiracetam Accord

Accord Healthcare Limited

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

ES/1/11/712

2015 5 29

2015 5 27

Myclausen

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33, D-14167 Berlin, Deutschland

ES/1/10/647

2015 5 29

2015 5 27

Nexium Control

Pfizer Consumer Healthcare Limited

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

ES/1/13/860

2015 5 29

2015 5 27

Nivestim

Hospira UK Limited

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

ES/1/10/631

2015 5 29

2015 5 27

Prepandrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

ES/1/08/453

2015 5 29

2015 5 27

Raloxifene Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/10/627

2015 6 29

2015 5 27

Relistor

TMC Pharma Services Ltd

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

ES/1/08/463

2015 5 29

2015 5 27

Resolor

Shire Pharmaceuticals Ireland Limited

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

ES/1/09/581

2015 5 29

2015 5 27

Selincro

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

ES/1/12/815

2015 5 29

2015 5 27

Silgard

Merck Sharp & Dohme Limited

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

ES/1/06/358

2015 5 29

2015 5 27

Sonata

MEDA AB

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

ES/1/99/102

2015 5 29

2015 5 27

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/13/894

2015 5 29

2015 5 27

Targretin

Eisai Limited

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

ES/1/01/178

2015 5 29

2015 5 27

Temodal

Merck Sharp & Dohme Limited

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

ES/1/98/096

2015 5 29

2015 5 27

Temozolomide Accord

Accord Healthcare Limited

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

ES/1/10/615

2015 5 29

2015 5 27

Thalidomide Celgene

Celgene Europe Limited

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

ES/1/08/443

2015 5 29

2015 5 27

Tolucombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/13/821

2015 5 29

2015 5 27

Volibris

Glaxo Group Ltd

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

ES/1/08/451

2015 5 29

2015 5 27

Xeristar

Eli Lilly Nederland B.V.

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

ES/1/04/297

2015 5 29

2015 5 27

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

ES/1/13/846

2015 5 29

2015 5 27

Yentreve

Eli Lilly Nederland B.V.

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

ES/1/04/280

2015 5 29

2015 5 27

Yondelis

Pharma Mar S.A.

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

ES/1/07/417

2015 5 29

2015 5 28

Aclasta

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/05/308

2015 6 1

2015 5 28

alli

Glaxo Group Ltd

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

ES/1/07/401

2015 6 1

2015 5 28

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

ES/1/11/733

2015 6 1

2015 5 28

Invega

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

ES/1/07/395

2015 6 1

2015 5 28

Januvia

Merck Sharp & Dohme Limited

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

ES/1/07/383

2015 6 1

2015 5 28

Lonquex

UAB „Sicor Biotech“

Molėtų pl. 5, LT-08409 Vilnius, Lietuva

ES/1/13/856

2015 6 1

2015 5 28

Ristaben

Merck Sharp & Dohme Limited

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

ES/1/10/621

2015 6 1

2015 5 28

Topotecan Hospira

Hospira UK Limited

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

ES/1/10/633

2015 6 1

2015 5 28

Tygacil

Pfizer Limited

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

ES/1/06/336

2015 6 1

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

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 5 5 | Clopidogrel DURA | Mylan dura GmbH
  Wittichstraße 6, D-64295 Darmstadt, Deutschland | ES/1/09/560 | 2015 5 7 |
| 2015 5 6 | Provenge | Dendreon UK Limited
  41 Chalton Street, London NW1 1JD, United Kingdom | ES/1/13/867 | 2015 5 8 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 5 5

Clopidogrel DURA

Mylan dura GmbH

Wittichstraße 6, D-64295 Darmstadt, Deutschland

ES/1/09/560

2015 5 7

2015 5 6

Provenge

Dendreon UK Limited

41 Chalton Street, London NW1 1JD, United Kingdom

ES/1/13/867

2015 5 8

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

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 5 5 | MS-H Vaccine | Pharmsure International Ltd
  Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom | ES/2/11/126 | 2015 5 7 |
| 2015 5 5 | Purevax RCP | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | ES/2/04/052 | 2015 5 7 |
| 2015 5 13 | Nobilis IB 4–91 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | ES/2/98/006 | 2015 5 19 |
| 2015 5 13 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | ES/2/07/078 | 2015 5 19 |
| 2015 5 27 | Meloxivet | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | ES/2/07/077 | 2015 5 29 |
| 2015 5 27 | Purevax FeLV | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | ES/2/00/019 | 2015 5 29 |
| 2015 5 27 | Purevax RCPCh | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | ES/2/04/050 | 2015 5 29 |
| 2015 5 27 | Suprelorin | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France | ES/2/07/072 | 2015 5 29 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 5 5

MS-H Vaccine

Pharmsure International Ltd

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

ES/2/11/126

2015 5 7

2015 5 5

Purevax RCP

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

ES/2/04/052

2015 5 7

2015 5 13

Nobilis IB 4–91

Intervet International B.V.

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

ES/2/98/006

2015 5 19

2015 5 13

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

ES/2/07/078

2015 5 19

2015 5 27

Meloxivet

Eli Lilly and Company Limited

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

ES/2/07/077

2015 5 29

2015 5 27

Purevax FeLV

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

ES/2/00/019

2015 5 29

2015 5 27

Purevax RCPCh

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

ES/2/04/050

2015 5 29

2015 5 27

Suprelorin

VIRBAC S.A.

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

ES/2/07/072

2015 5 29

Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:

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

---