31 results
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National expert: Ivana Golabova, State Institute for Drug Control (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 22.91 KB | PDF
Ivana Golabova … Ivana Golabova … Vitae Personal information Ivana Golabova Work experience … -
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National expert: Simona Jurkovic Mlakar, Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (updated)
- Declaration of interests - 39.32 KB | PDF
- Curriculum Vitae - 46.43 KB | PDF
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National expert: Martina Weise, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 40.46 KB | PDF
- Curriculum Vitae - 35.44 KB | PDF
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National expert: Salvatore Piano, European Medicines Agency (updated)
- Declaration of interests - 42.38 KB | PDF
- Curriculum Vitae - 29.13 KB | PDF
▪ Piano S, Marchioro L, Gola E, et al. Assessment of … -
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National expert: Dariusz Sladowski, Office For Registration Of Medicinal Products Medical Devices And Biocidal Products (updated)
- Declaration of interests - 41.77 KB | PDF
- Curriculum Vitae - 43.08 KB | PDF
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Human medicine European public assessment report (EPAR): Tezspire (updated)
tezepelumab, Asthma
Date of authorisation: 19/09/2022,
, Revision: 4, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Elonva
corifollitropin alfa, Reproductive Techniques, Assisted; Ovulation Induction; Investigative Techniques
Date of authorisation: 25/01/2010, Revision: 23, Authorised, Last updated: 05/04/2023 -
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Human medicine European public assessment report (EPAR): Rekovelle
follitropin delta, Anovulation
Date of authorisation: 12/12/2016, Revision: 5, Authorised, Last updated: 28/03/2022 -
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Human medicine European public assessment report (EPAR): Gazyvaro
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,, 
, Revision: 14, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Rapamune
Sirolimus, Graft Rejection; Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 46, Authorised, Last updated: 25/07/2022 -
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National expert: Ewa Balkowiec Iskra, Office For Registration Of Medicinal Products Medical Devices And Biocidal Products (updated)
- Declaration of interests - 40.66 KB | PDF
- Curriculum Vitae - 36.68 KB | PDF
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National expert: Renato Bassan, European Medicines Agency (updated)
- Declaration of interests - 41.03 KB | PDF
- Curriculum Vitae - 69.3 KB | PDF
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National expert: Robin Ristl, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 41.54 KB | PDF
- Curriculum Vitae - 60.12 KB | PDF
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National expert: Edo Richard, European Medicines Agency (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 66.71 KB | PDF
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National expert: Livia Puljak, Agency For Medicinal Products And Medical Devices Of Croatia (updated)
- Declaration of interests - 39.33 KB | PDF
- Curriculum Vitae - 73.98 KB | PDF
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Referral: Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome
terlipressin, Article 31 referrals
Status: CMDh final position, opinion/position date: 10/11/2022, Last updated: 22/11/2022 -
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Referral: Quinolones
enrofloxacin, marbofloxacin, danofloxacin mesilate, danofloxacin, flumequine, amoxicillin, difloxacin hydrochloride, oxolinic acid, Colistin sulfate, Amoxicillin trihydrate, difloxacin, bromhexine, oxytetracycline hydrochloride, Article 35
Status: European Commission final decision, opinion/position date: 09/03/2010, EC decision date: 01/07/2010, Last updated: 16/07/2010 -
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Direct healthcare professional communication (DHPC): Terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS)
Active substance: terlipressin, DHPC type: Referral - Article 31, Last updated: 17/02/2023 -
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Referral: Ambroxol and bromhexine-containing medicines
ambroxol, bromhexine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2015, EC decision date: 14/01/2016, Last updated: 05/02/2016 -
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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: Aldo Pietro Maggioni, European Medicines Agency (updated)
- Declaration of interests - 43.18 KB | PDF
- Curriculum Vitae - 284.53 KB | PDF
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Orphan designation: Vascular endothelial growth factor-D gene in an adenoviral vector for use with a collagen collar for: Prevention of stenosis in synthetic grafts used in haemodialysis
Date of designation: 08/06/2004, Positive, Last updated: 03/04/2014 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Annual reports and work programmes (updated)
Last updated: 15/05/2023 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development (updated)
Last updated: 11/05/2023