197 results
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Referral: Gadograf, Gadovist
gadobutrol, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 17/11/2006, EC decision date: 13/04/2007, Last updated: 09/11/2007Gadograf, Gadovist … Commission final decision Overview Gadovist/Gadograf 1.0 mmol/ml contains gadobutrol … classification of focal liver lesions. Gadovist/Gadograf was approved for " … -
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National expert: Eraldo Donnarumma, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 17.98 KB | PDF
PANORAMI E PERCORSI) "Doping: soluzione o inganno chimico? (BIF n.4/2006 … PERCORSI) "Il corretto uso delle erbe medicinali" (BIF … -
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National expert: Paola Minghetti, Italian Medicines Agency (updated)
- Declaration of interests - 81.41 KB | PDF
- Curriculum Vitae - 62.13 KB | PDF
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National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 80.05 KB | PDF
- Curriculum Vitae - 22.93 KB | PDF
quot;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: Paolo Porcelli, Italian Medicines Agency (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 28.23 KB | PDF
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National expert: Armando Magrelli, Italian Medicines Agency (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 29.06 KB | PDF
Agency http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9 http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79 http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9 Con Soluzioni Con Srl (Italy) Main activities … -
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Opinion/decision on a Paediatric investigation plan (PIP): Gadobutrol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic
PIP number: EMEA-000994-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2012, Last updated: 04/02/2014, Compliance check: V, 20/06/2014Key facts Gadovist Gadobutrol DiagnosticP/0311/2013EMEA-000994-PIP01-10-M01 … investigation plan for gadobutrol (Gadovist) (EMEA-000994-PIP01-10-M01 … investigation plan for gadobutrol (Gadovist) (EMEA-000994-PIP01-10-M01 … -
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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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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: 20/11/2009agents (Dotarem, ProHance and Gadovist), the CHMP recommended adding … agents (Dotarem, ProHance and Gadovist), the CHMP recommended adding … Gado-MRT-ratiopharm), gadobutrol (Gadovist), gadoteric acid (Dotarem … -
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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: 06/12/2010ProHance) and gadobutrol (Gadovist). The SAG also highlighted … ProHance) and gadobutrol (Gadovist). The SAG also highlighted … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,11-14 December 2006
CHMP, Last updated: 15/12/2006Gadovist/Gadograf … finalised referral procedures for Gadovist/Gadograf (gadobutrol) from Schering … -
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News: European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents
Last updated: 07/02/2007Multihance), gadobutrol (Gadovist), gadofosveset (Vasovist … -
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News: Public statement: Vasovist and nephrogenic systemic fibrosis (NSF)
Last updated: 07/02/2007Multihance), gadobutrol (Gadovist), gadofosveset (Vasovist … Multihance), gadobutrol (Gadovist), gadofosveset (Vasovist … -
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National expert: Maria Jose Otero Lopez, European Medicines Agency (updated)
- Declaration of interests - 79.94 KB | PDF
- Curriculum Vitae - 23.19 KB | PDF
coordinator). Recomendaciones para el Uso Seguro del Potasio Intravenoso … SENSAR) e Instituto para el Uso Seguro de los Medicamentos … Lopez Organisation/Company: Instituto para el Uso Seguro de los Medicamentos Country … -
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National expert: Emilia Cercenado Mansilla, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 80.77 KB | PDF
- Curriculum Vitae - 247.46 KB | PDF
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National expert: Giuseppina Ialongo, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 20.14 KB | PDF
Roma Aprile 1998, Seminario Interno U. O. Gruppo Grandi Rischi … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 May 2006
CHMP, Last updated: 02/06/2006Gadovist … as amended) were begun for Gadovist and Gadograf, from Schering … -
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Press release: EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
CHMP, Last updated: 21/07/2017intra-articular) maintain Gadovist ( gadobutrol ) macrocyclic … intra-articular) maintain Gadovist (gadobutrol) macrocyclic … -
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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 - 81.55 KB | PDF
- Curriculum Vitae - 27.96 KB | PDF
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National expert: Antonio Portolés, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 83 KB | PDF
- Curriculum Vitae - 41.23 KB | PDF
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National expert: Henrique Ramos da Costa, Directorate General For Food And Veterinary (updated)
- Declaration of interests - 80.03 KB | PDF
- Curriculum Vitae - 17.18 KB | PDF
medicamentos e outros produtos de uso veterinario: Sistema Nacional … medicamentos e outros produtos de uso veterinario: Sistema Nacional … medicamentos e outros produtos de uso veterinario: Sistema Nacional … -
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National expert: Juana de la Torre Aboki, European Medicines Agency (updated)
- Declaration of interests - 80.54 KB | PDF
- Curriculum Vitae - 25.48 KB | PDF
posicionamiento sobre el uso del metotrexato parenteral … Castellanos-Moreira, Jacqueline Uson, Esperanza Naredo, Terence … intra-articular therapies. Uson J, Rodriguez-Garcia SC, Castellanos-Moreira … -
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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