# Europos Sąjungos C 30/2018

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 30 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 61 metai2018m. sausio 26d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 30

Leidimas lietuvių kalba

Informacija ir pranešimai

61 metai2018m. sausio 26d.

---

| Pranešimo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2018/C 30/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. gruodžio 1 d. iki 2017 m. gruodžio 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |
| 2018/C 30/02 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. gruodžio 1 d. iki 2017 m. gruodžio 31 d.(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB 38 straipsnį) | 10 |

Pranešimo Nr.

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2018/C 30/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. gruodžio 1 d. iki 2017 m. gruodžio 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

2018/C 30/02

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. gruodžio 1 d. iki 2017 m. gruodžio 31 d.(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB 38 straipsnį)

(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB 38 straipsnį)

10

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

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 26.1.2018 | LT | Europos Sąjungos oficialusis leidinys | C 30/1 |
| --- | --- | --- | --- |

26.1.2018

LT

Europos Sąjungos oficialusis leidinys

C 30/1

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. gruodžio 1 d. iki 2017 m. gruodžio 31 d.

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

(2018/C 030/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2017 12 8 | Tacforius | Takrolimuzas | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/17/1244 | Pailginto atpalaidavimo kietos kapsulės | L04AD02 | 2017 12 12 |
| 2017 12 18 | Alecensa | alektinibas | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/16/1169 | Kieta kapsulė | L01XE36 | 2017 12 20 |

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

2017 12 8

Tacforius

Takrolimuzas

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/17/1244

Pailginto atpalaidavimo kietos kapsulės

L04AD02

2017 12 12

2017 12 18

Alecensa

alektinibas

Roche Registration Limited

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

ES/1/16/1169

Kieta kapsulė

L01XE36

2017 12 20

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

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2017 12 8 | Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech | XBiotech Germany GmbH
  Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland | — | 2017 12 12 |
| 2017 12 18 | Masipro | AB Science
  3 avenue George V, 75008 Paris, France | — | 2017 12 20 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2017 12 8

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

XBiotech Germany GmbH

Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland

—

2017 12 12

2017 12 18

Masipro

AB Science

3 avenue George V, 75008 Paris, France

—

2017 12 20

—   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 |
| --- | --- | --- | --- | --- |
| 2017 12 1 | Alecensa | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/16/1169 | 2017 12 5 |
| 2017 12 1 | Hetlioz | Vanda Pharmaceuticals Limited
  25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom | ES/1/15/1008 | 2017 12 5 |
| 2017 12 1 | Jakavi | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/12/773 | 2017 12 5 |
| 2017 12 1 | OCALIVA | Intercept Pharma Ltd
  2 Pancras Square, London N1C 4AG, United Kingdom | ES/1/16/1139 | 2017 12 5 |
| 2017 12 1 | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | ES/1/08/498 | 2017 12 5 |
| 2017 12 8 | Ceplene | Noventia Pharma Srl
  Via Carlo Pisacane 31, 47121 Forli, Italia | ES/1/08/477 | 2017 12 12 |
| 2017 12 8 | Dexdor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | ES/1/11/718 | 2017 12 12 |
| 2017 12 8 | Esbriet | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/11/667 | 2017 12 13 |
| 2017 12 8 | Esmya | Gedeon Richter Plc.
  Gyömrői út 19–21., 1103 Budapest, Magyarország | ES/1/12/750 | 2017 12 12 |
| 2017 12 8 | Genvoya | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/15/1061 | 2017 12 12 |
| 2017 12 8 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/11/677 | 2017 12 13 |
| 2017 12 8 | Humira | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | ES/1/03/256 | 2017 12 12 |
| 2017 12 8 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/07/383 | 2017 12 13 |
| 2017 12 8 | JETREA | ThromboGenics NV
  Gaston Geenslaan 1, 3001 Leuven, België | ES/1/13/819 | 2017 12 12 |
| 2017 12 8 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/15/1024 | 2017 12 13 |
| 2017 12 8 | Leganto | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | ES/1/11/695 | 2017 12 12 |
| 2017 12 8 | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | ES/1/13/869 | 2017 12 13 |
| 2017 12 8 | Moventig | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | ES/1/14/962 | 2017 12 12 |
| 2017 12 8 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | ES/1/14/988 | 2017 12 12 |
| 2017 12 8 | Oncaspar | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | ES/1/15/1070 | 2017 12 14 |
| 2017 12 8 | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/13/813 | 2017 12 13 |
| 2017 12 8 | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | ES/1/12/815 | 2017 12 12 |
| 2017 12 8 | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/15/1085 | 2017 12 12 |
| 2017 12 8 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/07/435 | 2017 12 13 |
| 2017 12 8 | Truberzi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | ES/1/16/1126 | 2017 12 12 |
| 2017 12 8 | Xiapex | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | ES/1/11/671 | 2017 12 12 |
| 2017 12 8 | Zevalin | Spectrum Pharmaceuticals B.V.
  Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland | ES/1/03/264 | 2017 12 12 |
| 2017 12 11 | EVOTAZ | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/15/1025 | 2017 12 13 |
| 2017 12 11 | Holoclar | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | ES/1/14/987 | 2017 12 13 |
| 2017 12 11 | Neupro | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | ES/1/05/331 | 2017 12 13 |
| 2017 12 11 | Odefsey | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/16/1112 | 2017 12 13 |
| 2017 12 11 | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | ES/1/10/643 | 2017 12 15 |
| 2017 12 11 | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/03/267 | 2017 12 13 |
| 2017 12 11 | Strensiq | Alexion Europe SAS
  1–15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | ES/1/15/1015 | 2017 12 13 |
| 2017 12 11 | Tarceva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/05/311 | 2017 12 13 |
| 2017 12 11 | Zyclara | MEDA AB
  Pipers väg 2A, 170 73 Solna, Sverige | ES/1/12/783 | 2017 12 13 |
| 2017 12 15 | Actelsar HCT | Actavis Group PTC ehf.
  Reykjavíkurvegi 76–78, 220 Hafnarfjörður, Íceland | ES/1/13/817 | 2017 12 19 |
| 2017 12 15 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/12/794 | 2017 12 19 |
| 2017 12 15 | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/08/457 | 2017 12 19 |
| 2017 12 15 | Eviplera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/11/737 | 2017 12 19 |
| 2017 12 15 | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/08/455 | 2017 12 19 |
| 2017 12 15 | M-M-RVAXPRO | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/06/337 | 2017 12 19 |
| 2017 12 15 | Procysbi | Chiesi Orphan B.V.
  Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland | ES/1/13/861 | 2017 12 19 |
| 2017 12 15 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/10/621 | 2017 12 19 |
| 2017 12 15 | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/10/620 | 2017 12 19 |
| 2017 12 15 | Stocrin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/99/111 | 2017 12 19 |
| 2017 12 15 | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/99/110 | 2017 12 19 |
| 2017 12 15 | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/08/456 | 2017 12 19 |
| 2017 12 18 | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/14/939 | 2017 12 20 |
| 2017 12 18 | Enbrel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/99/126 | 2017 12 20 |
| 2017 12 18 | HBVAXPRO | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/01/183 | 2017 12 20 |
| 2017 12 18 | NovoMix | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | ES/1/00/142 | 2017 12 20 |
| 2017 12 18 | ProQuad | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/05/323 | 2017 12 20 |
| 2017 12 18 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/07/382 | 2017 12 20 |
| 2017 12 20 | Azilect | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/04/304 | 2017 12 22 |
| 2017 12 20 | Duloxetine Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/14/972 | 2017 12 22 |
| 2017 12 20 | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/15/1051 | 2017 12 22 |
| 2017 12 20 | Efient | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | ES/1/08/503 | 2017 12 22 |
| 2017 12 20 | Fabrazyme | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | ES/1/01/188 | 2017 12 22 |
| 2017 12 20 | Gardasil | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/06/357 | 2017 12 22 |
| 2017 12 20 | Incresync | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/13/842 | 2017 12 20 |
| 2017 12 20 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | ES/1/06/368 | 2018 1 2 |
| 2017 12 20 | Levetiracetam ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | ES/1/11/702 | 2017 12 22 |
| 2017 12 20 | Levetiracetam SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | ES/1/11/741 | 2017 12 22 |
| 2017 12 20 | Qtern | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/16/1108 | 2017 12 22 |
| 2017 12 20 | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | ES/1/08/462 | 2017 12 22 |
| 2017 12 20 | Tivicay | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ES/1/13/892 | 2017 12 22 |
| 2017 12 20 | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/13/900 | 2017 12 22 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2017 12 1

Alecensa

Roche Registration Limited

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

ES/1/16/1169

2017 12 5

2017 12 1

Hetlioz

Vanda Pharmaceuticals Limited

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

ES/1/15/1008

2017 12 5

2017 12 1

Jakavi

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/12/773

2017 12 5

2017 12 1

OCALIVA

Intercept Pharma Ltd

2 Pancras Square, London N1C 4AG, United Kingdom

ES/1/16/1139

2017 12 5

2017 12 1

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

ES/1/08/498

2017 12 5

2017 12 8

Ceplene

Noventia Pharma Srl

Via Carlo Pisacane 31, 47121 Forli, Italia

ES/1/08/477

2017 12 12

2017 12 8

Dexdor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

ES/1/11/718

2017 12 12

2017 12 8

Esbriet

Roche Registration Limited

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

ES/1/11/667

2017 12 13

2017 12 8

Esmya

Gedeon Richter Plc.

Gyömrői út 19–21., 1103 Budapest, Magyarország

ES/1/12/750

2017 12 12

2017 12 8

Genvoya

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/15/1061

2017 12 12

2017 12 8

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/11/677

2017 12 13

2017 12 8

Humira

AbbVie Ltd

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

ES/1/03/256

2017 12 12

2017 12 8

Januvia

Merck Sharp & Dohme Limited

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

ES/1/07/383

2017 12 13

2017 12 8

JETREA

ThromboGenics NV

Gaston Geenslaan 1, 3001 Leuven, België

ES/1/13/819

2017 12 12

2017 12 8

KEYTRUDA

Merck Sharp & Dohme Limited

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

ES/1/15/1024

2017 12 13

2017 12 8

Leganto

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

ES/1/11/695

2017 12 12

2017 12 8

Lemtrada

Genzyme Therapeutics Ltd

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

ES/1/13/869

2017 12 13

2017 12 8

Moventig

Kyowa Kirin Limited

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

ES/1/14/962

2017 12 12

2017 12 8

Mysimba

Orexigen Therapeutics Ireland Limited

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

ES/1/14/988

2017 12 12

2017 12 8

Oncaspar

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

ES/1/15/1070

2017 12 14

2017 12 8

Perjeta

Roche Registration Limited

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

ES/1/13/813

2017 12 13

2017 12 8

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

ES/1/12/815

2017 12 12

2017 12 8

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/15/1085

2017 12 12

2017 12 8

Tesavel

Merck Sharp & Dohme Limited

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

ES/1/07/435

2017 12 13

2017 12 8

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

ES/1/16/1126

2017 12 12

2017 12 8

Xiapex

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

ES/1/11/671

2017 12 12

2017 12 8

Zevalin

Spectrum Pharmaceuticals B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

ES/1/03/264

2017 12 12

2017 12 11

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

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

ES/1/15/1025

2017 12 13

2017 12 11

Holoclar

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

ES/1/14/987

2017 12 13

2017 12 11

Neupro

UCB Pharma S.A.

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

ES/1/05/331

2017 12 13

2017 12 11

Odefsey

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/16/1112

2017 12 13

2017 12 11

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

ES/1/10/643

2017 12 15

2017 12 11

Reyataz

Bristol-Myers Squibb Pharma EEIG

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

ES/1/03/267

2017 12 13

2017 12 11

Strensiq

Alexion Europe SAS

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

ES/1/15/1015

2017 12 13

2017 12 11

Tarceva

Roche Registration Limited

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

ES/1/05/311

2017 12 13

2017 12 11

Zyclara

MEDA AB

Pipers väg 2A, 170 73 Solna, Sverige

ES/1/12/783

2017 12 13

2017 12 15

Actelsar HCT

Actavis Group PTC ehf.

Reykjavíkurvegi 76–78, 220 Hafnarfjörður, Íceland

ES/1/13/817

2017 12 19

2017 12 15

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/12/794

2017 12 19

2017 12 15

Efficib

Merck Sharp & Dohme Limited

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

ES/1/08/457

2017 12 19

2017 12 15

Eviplera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/11/737

2017 12 19

2017 12 15

Janumet

Merck Sharp & Dohme Limited

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

ES/1/08/455

2017 12 19

2017 12 15

M-M-RVAXPRO

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/06/337

2017 12 19

2017 12 15

Procysbi

Chiesi Orphan B.V.

Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland

ES/1/13/861

2017 12 19

2017 12 15

Ristaben

Merck Sharp & Dohme Limited

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

ES/1/10/621

2017 12 19

2017 12 15

Ristfor

Merck Sharp & Dohme Limited

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

ES/1/10/620

2017 12 19

2017 12 15

Stocrin

Merck Sharp & Dohme Limited

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

ES/1/99/111

2017 12 19

2017 12 15

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

ES/1/99/110

2017 12 19

2017 12 15

Velmetia

Merck Sharp & Dohme Limited

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

ES/1/08/456

2017 12 19

2017 12 18

Daklinza

Bristol-Myers Squibb Pharma EEIG

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

ES/1/14/939

2017 12 20

2017 12 18

Enbrel

Pfizer Limited

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

ES/1/99/126

2017 12 20

2017 12 18

HBVAXPRO

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/01/183

2017 12 20

2017 12 18

NovoMix

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

ES/1/00/142

2017 12 20

2017 12 18

ProQuad

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/05/323

2017 12 20

2017 12 18

Xelevia

Merck Sharp & Dohme Limited

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

ES/1/07/382

2017 12 20

2017 12 20

Azilect

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/04/304

2017 12 22

2017 12 20

Duloxetine Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/14/972

2017 12 22

2017 12 20

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/15/1051

2017 12 22

2017 12 20

Efient

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

ES/1/08/503

2017 12 22

2017 12 20

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

ES/1/01/188

2017 12 22

2017 12 20

Gardasil

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/06/357

2017 12 22

2017 12 20

Incresync

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/13/842

2017 12 20

2017 12 20

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

ES/1/06/368

2018 1 2

2017 12 20

Levetiracetam ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

ES/1/11/702

2017 12 22

2017 12 20

Levetiracetam SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

ES/1/11/741

2017 12 22

2017 12 20

Qtern

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/16/1108

2017 12 22

2017 12 20

Ranexa

Menarini International Operations Luxembourg S.A.

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

ES/1/08/462

2017 12 22

2017 12 20

Tivicay

ViiV Healthcare UK Limited

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

ES/1/13/892

2017 12 22

2017 12 20

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/13/900

2017 12 22

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

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2017 12 1 | Rabitec | Vakcina nuo pasiutligės (gyva, peroralinė), skirta lapėms ir usūriniams šunims | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | ES/2/17/219 | Geriamoji suspensija | QI07BD | 2017 12 5 |

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

2017 12 1

Rabitec

Vakcina nuo pasiutligės (gyva, peroralinė), skirta lapėms ir usūriniams šunims

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

ES/2/17/219

Geriamoji suspensija

QI07BD

2017 12 5

—   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 |
| --- | --- | --- | --- | --- |
| 2017 12 6 | Kexxtone | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | ES/2/12/145 | 2017 12 8 |
| 2017 12 6 | Spironolactone Ceva | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | ES/2/07/074 | 2017 12 8 |
| 2017 12 18 | Sedadex | Le Vet Beheer B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | ES/2/16/198 | 2017 12 20 |
| 2017 12 20 | Easotic | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | ES/2/08/085 | 2017 12 22 |
| 2017 12 20 | Leucogen | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | ES/2/09/096 | 2017 12 22 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2017 12 6

Kexxtone

Eli Lilly and Company Limited

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

ES/2/12/145

2017 12 8

2017 12 6

Spironolactone Ceva

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

ES/2/07/074

2017 12 8

2017 12 18

Sedadex

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

ES/2/16/198

2017 12 20

2017 12 20

Easotic

VIRBAC S.A.

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

ES/2/08/085

2017 12 22

2017 12 20

Leucogen

Virbac

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

ES/2/09/096

2017 12 22

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

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

---

| 26.1.2018 | LT | Europos Sąjungos oficialusis leidinys | C 30/10 |
| --- | --- | --- | --- |

26.1.2018

LT

Europos Sąjungos oficialusis leidinys

C 30/10

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2017 m. gruodžio 1 d. iki 2017 m. gruodžio 31 d.

(Sprendimai priimti pagal Direktyvos 2001/83/EB (1) 34 straipsnį arba Direktyvos 2001/82/EB (2) 38 straipsnį)

(2018/C 030/02)

—   Atsisakymas suteikti nacionalinį rinkodaros leidimą

| Sprendimo data | Vaisto pavadinimas (-ai) | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas (-ai) | Susijusi valstybė narė | Pranešimo data |
| --- | --- | --- | --- | --- | --- |
| 2017 12 18 | Alcover and associated names – Art 29 | Sodium oxybate | — | — | 2017 12 19 |

Sprendimo data

Vaisto pavadinimas (-ai)

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas (-ai)

Susijusi valstybė narė

Pranešimo data

2017 12 18

Alcover and associated names – Art 29

Sodium oxybate

—

—

2017 12 19

---

(1)  OL L 311, 2001 11 28, p. 67.

(2)  OL L 311, 2001 11 28, p. 1.

---