|
23.2.2018 |
LT |
Europos Sąjungos oficialusis leidinys |
C 70/1 |
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 |
|
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 |
|
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 |
|
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) |
|
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 |
|
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 |
|
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 |
(1) OL L 136, 2004 4 30, p. 1.