# Europos Sąjungos C 70/2018

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 70 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 61 metai2018m. vasario 23d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 70

Leidimas lietuvių kalba

Informacija ir pranešimai

61 metai2018m. vasario 23d.

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| Pranešimo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2018/C 70/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. sausio 1 d. iki 2018 m. sausio 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

2018/C 70/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. sausio 1 d. iki 2018 m. sausio 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

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LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 23.2.2018 | LT | Europos Sąjungos oficialusis leidinys | C 70/1 |
| --- | --- | --- | --- |

23.2.2018

LT

Europos Sąjungos oficialusis leidinys

C 70/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. sausio 1 d. iki 2018 m. sausio 31 d.

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

(2018/C 070/01)

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2018 1 8 | ADYNOVI | rurioctocog alfa pegol | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/17/1247 | Milteliai ir tirpiklis injekciniam tirpalui | B02BD02 | 2018 1 10 |
| 2018 1 8 | Fasenra | benralizumabas | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1252 | Injekcinis tirpalas | R03DX10 | 2018 1 10 |
| 2018 1 8 | Fulvestrant Mylan | fulvestranto | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1253 | Injekcinis tirpalas | L02BA03 | 2018 1 10 |
| 2018 1 8 | Intrarosa | prasteronas | Endoceutics Ltd.
  Salisbury house, London Wall, London, EC2M 5PS, United Kingdom | EU/1/17/1255 | Ovulės | QM01AX92 | 2018 2 6 |
| 2018 1 8 | Jorveza | budezonidas | Dr Falk Pharma GmbH
  Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland | EU/1/17/1254 | Burnoje disperguojamoji tabletė | A07EA06 | 2018 1 10 |
| 2018 1 8 | Ocrevus | okrelizumabas | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/17/1231 | Koncentratas infuziniam tirpalui | L04AA36 | 2018 1 10 |
| 2018 1 8 | PREVYMIS | letermoviras | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/17/1245 | Koncentratas infuziniam tirpalui
  Plėvele dengta tabletė | J05AX18 | 2018 1 10 |
| 2018 1 15 | Mvasi | bevacizumabas | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/17/1246 | Koncentratas infuziniam tirpalui | L01XC07 | 2018 1 17 |
| 2018 1 18 | Darunavir Krka d.d. | darunaviras | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1248 | Plėvele dengta tabletė | J05AE10 | 2018 1 22 |
| 2018 1 26 | Darunavir Krka | darunaviras | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1249 | Plėvele dengta tabletė | J05AE10 | 2018 1 30 |

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

2018 1 8

ADYNOVI

rurioctocog alfa pegol

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/17/1247

Milteliai ir tirpiklis injekciniam tirpalui

B02BD02

2018 1 10

2018 1 8

Fasenra

benralizumabas

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

Injekcinis tirpalas

R03DX10

2018 1 10

2018 1 8

Fulvestrant Mylan

fulvestranto

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1253

Injekcinis tirpalas

L02BA03

2018 1 10

2018 1 8

Intrarosa

prasteronas

Endoceutics Ltd.

Salisbury house, London Wall, London, EC2M 5PS, United Kingdom

EU/1/17/1255

Ovulės

QM01AX92

2018 2 6

2018 1 8

Jorveza

budezonidas

Dr Falk Pharma GmbH

Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland

EU/1/17/1254

Burnoje disperguojamoji tabletė

A07EA06

2018 1 10

2018 1 8

Ocrevus

okrelizumabas

Roche Registration Limited

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

EU/1/17/1231

Koncentratas infuziniam tirpalui

L04AA36

2018 1 10

2018 1 8

PREVYMIS

letermoviras

Merck Sharp & Dohme Limited

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

EU/1/17/1245

Koncentratas infuziniam tirpalui

Plėvele dengta tabletė

J05AX18

2018 1 10

2018 1 15

Mvasi

bevacizumabas

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/17/1246

Koncentratas infuziniam tirpalui

L01XC07

2018 1 17

2018 1 18

Darunavir Krka d.d.

darunaviras

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1248

Plėvele dengta tabletė

J05AE10

2018 1 22

2018 1 26

Darunavir Krka

darunaviras

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1249

Plėvele dengta tabletė

J05AE10

2018 1 30

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

—

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 |
| --- | --- | --- | --- | --- |
| 2018 1 8 | Onzeald | Nektar Therapeutics UK Limited
  Elizabeth House, 13-19 Queen Street, Leeds LS1 2TW, United Kingdom | — | 2018 1 10 |
| 2018 1 15 | Fanaptum | Vanda Pharmaceuticals Limited
  222 Regent Street, London W1B 5TR, United Kingdom | — | 2018 1 19 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 1 8

Onzeald

Nektar Therapeutics UK Limited

Elizabeth House, 13-19 Queen Street, Leeds LS1 2TW, United Kingdom

—

2018 1 10

2018 1 15

Fanaptum

Vanda Pharmaceuticals Limited

222 Regent Street, London W1B 5TR, United Kingdom

—

2018 1 19

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

—

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 |
| --- | --- | --- | --- | --- |
| 2018 1 8 | Bronchitol | Pharmaxis Pharmaceuticals Limited
  25 Moorgate, London, EC2R 6AY, United Kingdom | EU/1/12/760 | 2018 1 10 |
| 2018 1 8 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 2018 1 10 |
| 2018 1 8 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 2018 1 10 |
| 2018 1 8 | Comtess | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/98/082 | 2018 1 10 |
| 2018 1 8 | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/13/828 | 2018 1 10 |
| 2018 1 8 | Hexyon | Sanofi Pasteur Europe
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/13/829 | 2018 1 10 |
| 2018 1 8 | HyQvia | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/13/840 | 2018 1 10 |
| 2018 1 8 | Imatinib Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/825 | 2018 1 10 |
| 2018 1 8 | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, 1030 Wien, Österreich | EU/1/08/501 | 2018 1 10 |
| 2018 1 8 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 2018 1 10 |
| 2018 1 8 | Memantine LEK | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/13/826 | 2018 1 10 |
| 2018 1 8 | Memantine Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/13/827 | 2018 1 15 |
| 2018 1 8 | Nemdatine | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/824 | 2018 1 10 |
| 2018 1 8 | Orkambi | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | 2018 1 10 |
| 2018 1 8 | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 2018 1 10 |
| 2018 1 8 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, 3446 GR Woerden, Nederland | EU/1/13/832 | 2018 1 10 |
| 2018 1 8 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 2018 1 10 |
| 2018 1 8 | Tolucombi | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 2018 1 10 |
| 2018 1 8 | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 2018 1 10 |
| 2018 1 8 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 2018 1 10 |
| 2018 1 8 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 2018 1 10 |
| 2018 1 8 | Zonegran | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/307 | 2018 1 10 |
| 2018 1 11 | Carbaglu | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/02/246 | 2018 1 15 |
| 2018 1 11 | Cinacalcet Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1054 | 2018 1 15 |
| 2018 1 11 | Cystadrops | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/15/1049 | 2018 1 15 |
| 2018 1 11 | Cystagon | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/97/039 | 2018 1 15 |
| 2018 1 11 | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1143 | 2018 1 15 |
| 2018 1 11 | Laventair | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/899 | 2018 1 15 |
| 2018 1 11 | Levetiracetam Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/701 | 2018 1 15 |
| 2018 1 11 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/924 | 2018 1 15 |
| 2018 1 15 | Adasuve | Ferrer Internacional S.A.
  Gran Via Carlos III, 94 08028 Barcelona, España | EU/1/13/823 | 2018 1 17 |
| 2018 1 15 | Ciambra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/15/1055 | 2018 1 17 |
| 2018 1 15 | Prialt | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/302 | 2018 1 17 |
| 2018 1 15 | Zostavax | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/341 | 2018 1 17 |
| 2018 1 18 | Bortezomib Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/16/1114 | 2018 1 22 |
| 2018 1 18 | Leganto | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/11/695 | 2018 1 22 |
| 2018 1 18 | Marixino | Consilient Health Ltd
  5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland | EU/1/13/820 | 2018 1 22 |
| 2018 1 18 | Omidria | Omeros London Limited
  Berkeley Square, London, W1J 6BD, United Kingdom | EU/1/15/1018 | 2018 1 22 |
| 2018 1 18 | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 2018 1 22 |
| 2018 1 18 | Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1127 | 2018 1 22 |
| 2018 1 18 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 2018 1 22 |
| 2018 1 18 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 2018 1 22 |
| 2018 1 24 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 2018 1 26 |
| 2018 1 24 | DUAVIVE | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/960 | 2018 1 26 |
| 2018 1 24 | IBRANCE | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/16/1147 | 2018 1 26 |
| 2018 1 24 | LeukoScan | Immunomedics GmbH
  Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland | EU/1/97/032 | 2018 1 26 |
| 2018 1 25 | Matever | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/11/711 | 2018 1 29 |
| 2018 1 26 | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/14/974 | 2018 1 30 |
| 2018 1 26 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 2018 1 30 |
| 2018 1 30 | Cialis | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/02/237 | 2018 1 31 |
| 2018 1 30 | Colobreathe | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/747 | 2018 2 1 |
| 2018 1 30 | Copalia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/372 | 2018 2 1 |
| 2018 1 30 | Copalia HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/575 | 2018 2 1 |
| 2018 1 30 | Cresemba | Basilea Medical Ltd
  c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom | EU/1/15/1036 | 2018 2 1 |
| 2018 1 30 | Dafiro | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/371 | 2018 2 1 |
| 2018 1 30 | Dafiro HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/574 | 2018 2 1 |
| 2018 1 30 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 2018 2 1 |
| 2018 1 30 | Effentora | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/441 | 2018 2 1 |
| 2018 1 30 | Exforge HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/569 | 2018 2 1 |
| 2018 1 30 | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/12/776 | 2018 2 1 |
| 2018 1 30 | Granpidam | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/16/1137 | 2018 2 1 |
| 2018 1 30 | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/11/687 | 2018 2 1 |
| 2018 1 30 | Ivemend | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437 | 2018 2 1 |
| 2018 1 30 | Nplate | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/08/497 | 2018 2 1 |
| 2018 1 30 | Rotarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/05/330 | 2018 2 1 |
| 2018 1 30 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/494 | 2018 2 2 |
| 2018 1 30 | Vectibix | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/07/423 | 2018 2 1 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 1 8

Bronchitol

Pharmaxis Pharmaceuticals Limited

25 Moorgate, London, EC2R 6AY, United Kingdom

EU/1/12/760

2018 1 10

2018 1 8

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

2018 1 10

2018 1 8

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

2018 1 10

2018 1 8

Comtess

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/98/082

2018 1 10

2018 1 8

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/13/828

2018 1 10

2018 1 8

Hexyon

Sanofi Pasteur Europe

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/13/829

2018 1 10

2018 1 8

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

2018 1 10

2018 1 8

Imatinib Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/825

2018 1 10

2018 1 8

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/08/501

2018 1 10

2018 1 8

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

2018 1 10

2018 1 8

Memantine LEK

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/13/826

2018 1 10

2018 1 8

Memantine Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/13/827

2018 1 15

2018 1 8

Nemdatine

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/824

2018 1 10

2018 1 8

Orkambi

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

2018 1 10

2018 1 8

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

2018 1 10

2018 1 8

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, 3446 GR Woerden, Nederland

EU/1/13/832

2018 1 10

2018 1 8

Synjardy

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

2018 1 10

2018 1 8

Tolucombi

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

2018 1 10

2018 1 8

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

2018 1 10

2018 1 8

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

2018 1 10

2018 1 8

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

2018 1 10

2018 1 8

Zonegran

Eisai Limited

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

EU/1/04/307

2018 1 10

2018 1 11

Carbaglu

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/02/246

2018 1 15

2018 1 11

Cinacalcet Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1054

2018 1 15

2018 1 11

Cystadrops

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/15/1049

2018 1 15

2018 1 11

Cystagon

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/97/039

2018 1 15

2018 1 11

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1143

2018 1 15

2018 1 11

Laventair

Glaxo Group Ltd

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

EU/1/14/899

2018 1 15

2018 1 11

Levetiracetam Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/701

2018 1 15

2018 1 11

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/924

2018 1 15

2018 1 15

Adasuve

Ferrer Internacional S.A.

Gran Via Carlos III, 94 08028 Barcelona, España

EU/1/13/823

2018 1 17

2018 1 15

Ciambra

Menarini International Operations Luxembourg S.A.

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

EU/1/15/1055

2018 1 17

2018 1 15

Prialt

Eisai Limited

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

EU/1/04/302

2018 1 17

2018 1 15

Zostavax

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/341

2018 1 17

2018 1 18

Bortezomib Hospira

Hospira UK Limited

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

EU/1/16/1114

2018 1 22

2018 1 18

Leganto

UCB Pharma S.A.

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

EU/1/11/695

2018 1 22

2018 1 18

Marixino

Consilient Health Ltd

5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/13/820

2018 1 22

2018 1 18

Omidria

Omeros London Limited

Berkeley Square, London, W1J 6BD, United Kingdom

EU/1/15/1018

2018 1 22

2018 1 18

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

2018 1 22

2018 1 18

Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1127

2018 1 22

2018 1 18

XALKORI

Pfizer Limited

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

EU/1/12/793

2018 1 22

2018 1 18

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

2018 1 22

2018 1 24

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

2018 1 26

2018 1 24

DUAVIVE

Pfizer Limited

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

EU/1/14/960

2018 1 26

2018 1 24

IBRANCE

Pfizer Limited

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

EU/1/16/1147

2018 1 26

2018 1 24

LeukoScan

Immunomedics GmbH

Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland

EU/1/97/032

2018 1 26

2018 1 25

Matever

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/11/711

2018 1 29

2018 1 26

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/14/974

2018 1 30

2018 1 26

Mysimba

Orexigen Therapeutics Ireland Limited

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

EU/1/14/988

2018 1 30

2018 1 30

Cialis

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/02/237

2018 1 31

2018 1 30

Colobreathe

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

2018 2 1

2018 1 30

Copalia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/372

2018 2 1

2018 1 30

Copalia HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/575

2018 2 1

2018 1 30

Cresemba

Basilea Medical Ltd

c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom

EU/1/15/1036

2018 2 1

2018 1 30

Dafiro

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/371

2018 2 1

2018 1 30

Dafiro HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/574

2018 2 1

2018 1 30

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

2018 2 1

2018 1 30

Effentora

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/441

2018 2 1

2018 1 30

Exforge HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/569

2018 2 1

2018 1 30

Fycompa

Eisai Europe Limited

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

EU/1/12/776

2018 2 1

2018 1 30

Granpidam

Accord Healthcare Limited

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

EU/1/16/1137

2018 2 1

2018 1 30

Hizentra

CSL Behring GmbH

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

EU/1/11/687

2018 2 1

2018 1 30

Ivemend

Merck Sharp & Dohme Limited

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

EU/1/07/437

2018 2 1

2018 1 30

Nplate

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497

2018 2 1

2018 1 30

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/05/330

2018 2 1

2018 1 30

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

2018 2 2

2018 1 30

Vectibix

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/07/423

2018 2 1

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

—

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 |
| --- | --- | --- | --- | --- |
| 2018 1 11 | Daliresp | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/668 | 2018 1 15 |
| 2018 1 11 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/06/368 | 2018 1 15 |
| 2018 1 11 | Libertek | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/666 | 2018 1 15 |
| 2018 1 18 | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 2018 1 22 |
| 2018 1 30 | LeukoScan | Immunomedics GmbH
  Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland | EU/1/97/032 | 2018 2 1 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 1 11

Daliresp

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/668

2018 1 15

2018 1 11

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368

2018 1 15

2018 1 11

Libertek

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/666

2018 1 15

2018 1 18

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/772

2018 1 22

2018 1 30

LeukoScan

Immunomedics GmbH

Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland

EU/1/97/032

2018 2 1

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2018 1 9 | GALLIPRANT | grapiprantas | Aratana Therapeutics NV
  Ambachtenlaan 1, 3001 Heverlee, België | EU/2/17/221 | Tabletės | QM01AX92 | 2018 1 11 |
| 2018 1 31 | MiPet Easecto | sarolaneras | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/220 | Kramtomos tabletės | QP53BE03 | 2018 2 2 |

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

2018 1 9

GALLIPRANT

grapiprantas

Aratana Therapeutics NV

Ambachtenlaan 1, 3001 Heverlee, België

EU/2/17/221

Tabletės

QM01AX92

2018 1 11

2018 1 31

MiPet Easecto

sarolaneras

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/17/220

Kramtomos tabletės

QP53BE03

2018 2 2

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

—

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 |
| --- | --- | --- | --- | --- |
| 2018 1 9 | Cortavance | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/06/069 | 2018 1 11 |
| 2018 1 9 | Ypozane | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/06/068 | 2018 1 11 |
| 2018 1 12 | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/153 | 2018 1 16 |
| 2018 1 12 | Leucofeligen FeLV/RCP | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/09/097 | 2018 1 16 |
| 2018 1 12 | Virbagen Omega | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/01/030 | 2018 1 16 |
| 2018 1 12 | Zactran | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/08/082 | 2018 1 16 |
| 2018 1 16 | Semintra | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/146 | 2018 1 18 |
| 2018 1 31 | Meloxoral | Le Vet B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/10/111 | 2018 2 2 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 1 9

Cortavance

VIRBAC S.A.

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

EU/2/06/069

2018 1 11

2018 1 9

Ypozane

VIRBAC S.A.

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

EU/2/06/068

2018 1 11

2018 1 12

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/153

2018 1 16

2018 1 12

Leucofeligen FeLV/RCP

Virbac

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

EU/2/09/097

2018 1 16

2018 1 12

Virbagen Omega

VIRBAC S.A.

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

EU/2/01/030

2018 1 16

2018 1 12

Zactran

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/08/082

2018 1 16

2018 1 16

Semintra

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/146

2018 1 18

2018 1 31

Meloxoral

Le Vet B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/10/111

2018 2 2

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

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

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