131 results
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National expert: Ekaterini Tiligada, National Organization For Medicines (updated)
- Declaration of interests - 40.02 KB | PDF
- Curriculum Vitae - 101.93 KB | PDF
sulfoxide modifies growth and senescence and induces the non_revertible … -
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National expert: Bruno Quesnel, European Medicines Agency (updated)
- Declaration of interests - 43.39 KB | PDF
- Curriculum Vitae - 76.38 KB | PDF
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National expert: Heidi Foth, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.92 KB | PDF
- Curriculum Vitae - 52.34 KB | PDF
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National expert: Loreta Kondili, Italian Medicines Agency (updated)
- Declaration of interests - 41.79 KB | PDF
- Curriculum Vitae - 53.47 KB | PDF
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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: Short-acting beta-agonists
terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol, isoxsuprine, Article 31 referrals
Status: CMDh final position, opinion/position date: 23/10/2013, Last updated: 07/11/2013 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Opinion on medicine for use outside EU: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue, ATC code: J07BX04 Opinion number: EMEA/H/W/005362, Positive opinion Opinion date: 13/10/2022, Last updated: 14/12/2022 -
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National expert: Alessandro Aiuti, European Medicines Agency (updated)
- Declaration of interests - 47.09 KB | PDF
- Curriculum Vitae - 147.43 KB | PDF
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Referral: Sibutramine
Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2002, EC decision date: 26/03/2001, Last updated: 13/12/2002 -
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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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National expert: Michael Denkinger, European Medicines Agency (updated)
- Declaration of interests - 40.62 KB | PDF
- Curriculum Vitae - 65.01 KB | PDF
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Referral: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen, dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015 -
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Orphan designation: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with a lentiviral vector encoding for the N-acetylgalactosamine 6-sulfatase cDNA for: Treatment of mucopolysaccharidosis type IV A (Morquio A syndrome)
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Toll-like receptor 4 agonist for: Treatment of osteosarcoma
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Nanatinostat, Valganciclovir for: Treatment of peripheral T-cell lymphoma
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Lithium carbonate for: Treatment of familial adenomatous polyposis (FAP)
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Bezafibrate for: Treatment of primary sclerosing cholangitis
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Mazindol for: Treatment of idiopathic hypersomnia
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: H-Lys-Lys-Gly-Asp-Asn-Ile-Met-Val-Thr-Phe-Arg-Asn-Gln-Ala-Ser-Arg-Pro-Tyr-Gly-Lys-Lys-OH for: Treatment of haemophilia A
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Calmangafodipir for: Prevention of acute liver failure
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Allogeneic placenta-derived decidual stromal cells for: Treatment of graft-versus-host-disease
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Epetraborole for: Treatment of nontuberculous mycobacterial lung disease
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Autologous human bone marrow-derived haematopoietic and mesenchymal stem cells depleted of erythrocytes, monocytes and lymphocytes for: Treatment of frontotemporal dementia
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022 -
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Orphan designation: Vutrisiran for: Treatment of Stargardt's disease
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022