43 results
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Veterinary medicine European public assessment report (EPAR): Vectormune ND
cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain, Chicken; Embryonated eggs
Date of authorisation: 08/09/2015, Revision: 7, Authorised, Last updated: 06/09/2021Newcastle disease virus (D-26 lentogenic strain). How is Vectormune … Newcastle disease virus (D-26 lentogenic strain). Vectormune … Newcastle diseases virus D-26 lentogenic strain … -
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Referral: Hydroxyprogesterone-containing medicinal products (new)
hydroxyprogesterone, associated names: Lentogest, Progesterone Retard Pharlon, Proluton Depot, Article 31 referrals
Status: Procedure started, Last updated: 12/05/2023Progesterone Retard Pharlon and Lentogest. More about the procedure … Progesterone Retard Pharlon and Lentogest. More about the procedure … -
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National expert: Marion Haberkamp, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.27 KB | PDF
- Curriculum Vitae - 32.75 KB | PDF
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National expert: André Elferink, Medicines Evaluation Board (updated)
- Declaration of interests - 39.4 KB | PDF
- Curriculum Vitae - 31.74 KB | PDF
MH, Jones EJ, Khwaja OS, Lenton S, Mason L, Mantua V, Meyer_Lindenberg … -
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Veterinary medicine European public assessment report (EPAR): Innovax-ND-ILT
Cell-associated live recombinant turkey herpesvirus (strain HVT/NDV/ILT) expressing the fusion protein of newcastle disease virus and the glycoproteins gD and gI of infectious laryngotracheitis virus, Embryonated chicken eggs; Chicken
Date of authorisation: 16/09/2020, Revision: 1, Authorised, Last updated: 24/03/2021 -
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National expert: Etienne Schmitt, European Medicines Agency (updated)
- Declaration of interests - 39.61 KB | PDF
- Curriculum Vitae - 48.96 KB | PDF
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National expert: Adamos Hadjipanayis, European Medicines Agency (updated)
- Declaration of interests - 39.65 KB | PDF
- Curriculum Vitae - 246.86 KB | PDF
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National expert: Karl Broich, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 78.62 KB | PDF
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014 -
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013 -
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Referral: Baxter dialysis solutions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, Last updated: 20/11/2013 -
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Referral: Avinew
live Newcastle disease virus, VG/GA strain, Article 33
Status: European Commission final decision, opinion/position date: 12/09/2001, EC decision date: 04/02/2002, Last updated: 05/08/2014strain. The VG/GA strain is lentogenic and naturally apathogenic … -
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Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector encoding the human beta-globin gene for: Treatment of beta thalassaemia intermedia and major
Date of designation: 29/04/2009, Positive, Last updated: 24/03/2023 -
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Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene (betibeglogene autotemcel) for: Treatment of beta thalassaemia intermedia and major
Date of designation: 24/01/2013, Withdrawn, Last updated: 30/11/2022 -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021Trikaliumcitratmonohydrat og kaliumhydrogencarbonat Behandling af distal renal … Trikaliumcitraatmonohydraat en kaliumbicarbonaat Behandeling van distale … Trikaliumsitraatti monohydraatti ja kaliumvetykarbonaatti Distaalisen renaalisen … -
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Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene for: The treatment of sickle cell disease
Date of designation: 29/04/2014, Withdrawn, Last updated: 07/12/2021 -
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Orphan designation: tegafur, gimeracil, oteracil potassium for: Treatment of gastric cancer
Date of designation: 20/12/2007, Withdrawn, Last updated: 28/03/2011Tegafur, gimeracil, oteracil kalium Behandlingen af cancer ventriculi … Tegafur, gimeracil, oteracil kalium Behandeling van maagkanker … Finnish Tegafuuri, gimerasiili, kaliumoterasiili Mahasyövän hoito French … -
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Orphan designation: autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1 for: Treatment of soft tissue sarcoma
Date of designation: 14/07/2016, Positive, Last updated: 07/04/2020 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022 -
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Guidance documents
Last updated: 19/07/2022 -
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Scientific publications (updated)
Last updated: 31/05/2023 -
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News: EMA's medical literature monitoring enters into full operation
Last updated: 01/09/2015 -
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News: Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups
Last updated: 12/05/2015 -
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Product information: Reference documents and guidelines
Last updated: 31/12/2020