248 results
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Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology; Immunology-Rheumatology-Transplantation
PIP number: EMEA-000645-PIP03-18, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Solution for injection
Decision date: 14/08/2019, Last updated: 09/11/2022, Compliance check: XInvented name Entyvio Active substance vedolizumab … vedolizumab Invented name: Entyvio Latest Decision number(s … Entyvio Entyvio vedolizumab vedolizumab ve … -
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Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000645-PIP01-09-M08, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Solution for injection in pre-filled syringe
Decision date: 31/12/2021, Last updated: 24/07/2018, Compliance check: XInvented name Entyvio Active substance vedolizumab … investigation plan for vedolizumab (Entyvio), (EMEA-000645-PIP01-09-M08 … investigation plan for vedolizumab (Entyvio), (EMEA-000645-PIP01-09-M08 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000645-PIP04-20, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Solution for injection
Decision date: 10/05/2021, Last updated: 11/02/2022, Compliance check: XInvented name Entyvio Active substance vedolizumab … a waiver for vedolizumab (Entyvio), (EMEA-000645-PIP04-20 … a waiver for vedolizumab (Entyvio), (EMEA-000645-PIP04-20 … -
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Human medicine European public assessment report (EPAR): Entyvio
vedolizumab, Colitis, Ulcerative; Crohn Disease
Date of authorisation: 22/05/2014, Revision: 24, Authorised, Last updated: 25/04/2023Entyvio Digestive System Diseases Gastrointestinal … horised vedolizumab Overview Entyvio is a medicine used to treat … of the digestive tract). Entyvio is used to treat moderately … -
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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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Direct healthcare professional communications
Last updated: 14/02/2020 -
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Press release: European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease
CHMP, Last updated: 21/03/2014Entyvio (vedolizumab) offers a treatment … colitis and Crohn’s disease Entyvio (vedolizumab) offers a treatment … marketing authorisation for Entyvio (vedolizumab) for the treatment … -
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News: European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014
Last updated: 10/07/2014obinutuzumab), the anti-inflammatory* Entyvio (vedolizumab), the anti-infective … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020
CHMP, Last updated: 28/02/2020Entyvio … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 March 2014
CHMP, Last updated: 21/03/2014Entyvio … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
CHMP, Last updated: 17/12/2021Entyvio … -
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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: 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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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