188 results
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National expert: Paolo Porcelli, Italian Medicines Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 41.49 KB | PDF
“La valutazione dell’uso e della sicurezza dei farmaci … -
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National expert: Eraldo Donnarumma, Italian Medicines Agency (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 25.83 KB | PDF
PANORAMI E PERCORSI) “Doping: soluzione o inganno chimico? (BIF n.4/2006 … PERCORSI) “Il corretto uso delle erbe medicinali” … -
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Veterinary medicine European public assessment report (EPAR): Convenia
cefovecin (as sodium salt), Dogs; Cats
Date of authorisation: 19/06/2006, Revision: 13, Authorised, Last updated: 08/12/2020Usobacterium … -
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Referral: Gadolinium-containing contrast agents
gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol, gadoteric acid, associated names: Omniscan, Magnevist, Magnegita, Gado-MRT ratiopharm, Primovist, MultiHance, Dotarem, ProHance, Gadovist, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 06/12/2010gadoteric acid (Dotarem), gadoteridol (ProHance … low risk: gadoteric acid (Dotarem), gadoteridol (ProHance … -
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Direct healthcare professional communications
Last updated: 14/02/2020 -
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Press release: European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents
Last updated: 20/11/2009MultiHance) and low-risk agents (Dotarem, ProHance and Gadovist … MultiHance) and low-risk agents (Dotarem, ProHance and Gadovist … Gadovist), gadoteric acid (Dotarem), gadoteridol (ProHance … -
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Press release: EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
CHMP, Last updated: 21/07/2017Artirem / Dotarem ( gadoteric acid ) macrocyclic … i.v.) maintain Artirem / Dotarem ( gadoteric acid ) macrocyclic … Recommendation Artirem / Dotarem (gadoteric acid) macrocyclic … -
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Referral: Gadolinium-containing contrast agents
gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide, gadoxetic acid, associated names: Optimark, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/07/2017, EC decision date: 23/11/2017, Last updated: 04/12/2017Artirem / Dotarem ( gadoteric acid ) macrocyclic … i.v.) maintain Artirem / Dotarem ( gadoteric acid ) macrocyclic … Recommendation Artirem / Dotarem (gadoteric acid) macrocyclic … -
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National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 39.64 KB | PDF
- Curriculum Vitae - 31.8 KB | PDF
“Contaminazione da alluminio in soluzioni di albumina umana: un monitoraggio … dell’attivatore della precallicreina in soluzioni di albumina umana” (Abs … -
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National expert: Maria da Graca Ribeiro Campos, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 39.36 KB | PDF
- Curriculum Vitae - 240.74 KB | PDF
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National expert: Emilia Cercenado Mansilla, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 41.48 KB | PDF
- Curriculum Vitae - 468.19 KB | PDF
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National expert: Bozenna Dembowska-Baginska, Office For Registration Of Medicinal Products Medical Devices And Biocidal Products (updated)
- Declaration of interests - 44.48 KB | PDF
- Curriculum Vitae - 26.56 KB | PDF
indication Past 01-01- 2015 01-01- 2016 Guerbet DOTAREM imaging contrast agent for … -
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National expert: Giuseppina Ialongo, Italian Medicines Agency (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 58.25 KB | PDF
Roma Aprile 1998, Seminario Interno U. O. Gruppo Grandi Rischi … -
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Human medicine European public assessment report (EPAR): Fampyra
Fampridine, Multiple Sclerosis
Date of authorisation: 20/07/2011, Revision: 16, Authorised, Last updated: 05/05/2022 -
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National expert: Francesca Rocchi, Italian Medicines Agency (updated)
- Declaration of interests - 41.46 KB | PDF
- Curriculum Vitae - 59.71 KB | PDF
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National expert: Antonio Portolés, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 44.48 KB | PDF
- Curriculum Vitae - 54.67 KB | PDF
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Human medicine European public assessment report (EPAR): Bavencio
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,
, Revision: 15, Authorised, Last updated: 24/03/2023
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National expert: Maria Jose Otero Lopez, European Medicines Agency (updated)
- Declaration of interests - 39.88 KB | PDF
- Curriculum Vitae - 32.45 KB | PDF
coordinator). Recomendaciones para el Uso Seguro del Potasio Intravenoso … SENSAR) e Instituto para el Uso Seguro de los Medicamentos … -
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National expert: Henrique Ramos da Costa, Directorate General For Food And Veterinary (updated)
- Declaration of interests - 39.92 KB | PDF
- Curriculum Vitae - 25.2 KB | PDF
medicamentos e outros produtos de uso veterinário: Sistema Nacional … medicamentos e outros produtos de uso veterinário: Sistema Nacional … medicamentos e outros produtos de uso veterinário: Sistema Nacional … -
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Human medicine European public assessment report (EPAR): Optimark
gadoversetamide, Magnetic Resonance Imaging
Date of authorisation: 23/07/2007, Revision: 14, Withdrawn, Last updated: 11/12/2017low risk: gadoteric acid (Dotarem), gadoteridol (ProHance … -
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Human medicine European public assessment report (EPAR): Ablavar (previously Vasovist)
gadofosveset trisodium, Magnetic Resonance Angiography
Date of authorisation: 03/10/2005, Revision: 10, Withdrawn, Last updated: 14/11/2011low risk: gadoteric acid (Dotarem), gadoteridol (ProHance … -
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National expert: Edurne Lazaro, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 39.31 KB | PDF
- Curriculum Vitae - 30.61 KB | PDF
Farmacovigilancia de medicamentos de Uso Humano. FEDRA: La base de … Farmacovigilancia de Medicamentos de Uso Humano. M Madurga, E. Lázaro … Farmacovigilancia de medicamentos de Uso Humano. Sistema Español … -
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Human medicine European public assessment report (EPAR): Cinryze
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,, Revision: 23, Authorised, Last updated: 10/10/2022
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National expert: Juana de la Torre Aboki, European Medicines Agency (updated)
- Declaration of interests - 40.6 KB | PDF
- Curriculum Vitae - 36.08 KB | PDF
posicionamiento sobre el uso del metotrexato parenteral … Castellanos_Moreira, Jacqueline Uson, Esperanza Naredo, Terence … -
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Human medicine European public assessment report (EPAR): Eladynos (updated)
abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis, Revision: 1, Authorised, Last updated: 22/05/2023