188 results
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Referral: Avalox
moxifloxacin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/06/2009, EC decision date: 02/10/2009, Last updated: 19/11/2013Avalox … authorisation of the medicine Avalox solution for infusion. The … concluded that the benefits of Avalox solution for infusion outweigh … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Moxifloxacin hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000288-PIP01-08-M02, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Solution for infusion, Granules and solvent for oral suspension
Decision date: 24/11/2010, Last updated: 21/12/2010, Compliance check: XKey facts Avalox and associated names; Octegra … moxifloxacin hydrochloride (Avalox and associated names; Octegra … moxifloxacin hydrochloride (Avalox and associated names; Octegra … -
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Referral: Moxifloxacin
moxifloxacin, associated names: Avalox, Avelox, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 24/07/2008, EC decision date: 24/10/2008, Last updated: 24/07/2008Member States as Avelox and Avalox, as well as other invented … medicineMoxifloxacinmoxifloxacin Avalox Avelox About this procedureCHMP/380454/08 … Member States as Avelox and Avalox, as well as other invented … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,17-19 March 2008
CHMP, Last updated: 20/03/2008Actira, Avalox, Octegra and associated invented … -
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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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National expert: Ana Catarina Fonseca, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 39.22 KB | PDF
- Curriculum Vitae - 53.08 KB | PDF
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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: Javier Espíldora Hernández, European Medicines Agency (updated)
- Declaration of interests - 111.5 KB | PDF
- Curriculum Vitae - 27.12 KB | PDF
Avanzado para Especialistas Internos Residentes (IAVANTE). Málaga … -
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National expert: Giuseppina Ialongo, Italian Medicines Agency (updated)
- Declaration of interests - 39.22 KB | PDF
- Curriculum Vitae - 58.26 KB | PDF
Roma Aprile 1998, Seminario Interno U. O. Gruppo Grandi Rischi … -
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National expert: Francesca Rocchi, Italian Medicines Agency (updated)
- Declaration of interests - 40.65 KB | PDF
- Curriculum Vitae - 59.71 KB | PDF
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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: Antonio Portolés, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 44.8 KB | PDF
- Curriculum Vitae - 54.71 KB | PDF
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National expert: Henrique Ramos da Costa, Directorate General For Food And Veterinary (updated)
- Declaration of interests - 39.93 KB | PDF
- Curriculum Vitae - 25.21 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: Maria Jose Otero Lopez, European Medicines Agency (updated)
- Declaration of interests - 10.78 KB | PDF
- Curriculum Vitae - 33.5 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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Human medicine European public assessment report (EPAR): Bavencio
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,, Revision: 16, Authorised, Last updated: 30/08/2023
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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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Human medicine European public assessment report (EPAR): Tysabri (updated)
natalizumab, Multiple Sclerosis
Date of authorisation: 27/06/2006, Revision: 41, Authorised, Last updated: 20/11/2023 -
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Human medicine European public assessment report (EPAR): Brintellix
Vortioxetine, Depressive Disorder, Major
Date of authorisation: 18/12/2013, Revision: 23, Authorised, Last updated: 24/10/2023 -
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Human medicine European public assessment report (EPAR): Eladynos
abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis
Date of authorisation: 12/12/2022,, Revision: 2, Authorised, Last updated: 25/08/2023
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Veterinary medicine European public assessment report (EPAR): Evant
Eimeria acervulina, strain 003, Eimeria maxima, strain 013, Eimeria mitis, strain 006, Eimeria praecox, strain 007, Eimeria tenella, strain 004, Chicken
Date of authorisation: 05/02/2019, Revision: 1, Authorised, Last updated: 04/03/2022