725 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: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen, dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015including COX-2 inhibitors and diclofenac. No increase in cardiovascular … including COX-2 inhibitors and diclofenac. For diclofenac, the risk was estimated at … every 1,000 patients taking diclofenac for a year. Use of high-dose … -
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Direct healthcare professional communications
Last updated: 14/02/2020 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29-31 October 2012
PRAC, Last updated: 31/10/2012Review of diclofenac-containing medicines started … -
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Referral: Arcoxia
etoricoxib, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 26/06/2008, EC decision date: 09/09/2008, Last updated: 21/11/2008similar CV thrombotic risk like diclofenac and some degree of upper … advantage over naproxen and diclofenac (though no particular lower … drugs (NSAIDs) other than diclofenac and naproxen. It was therefore … -
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Press release: European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs
CHMP, Last updated: 19/10/2012updated treatment advice for diclofenac in follow-on review … updated treatment advice for diclofenac in follow-on review The … most widely used NSAIDs – diclofenac, ibuprofen and naproxen. In … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013
PRAC, Last updated: 14/06/2013PRAC recommendation on diclofenac … -
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 20/01/2012, Last updated: 19/04/2012NSAID pain killers such as diclofenac, ibuprofen and naproxen. In … NSAID pain killers such as diclofenac, ibuprofen and naproxen … -
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Press release: Pharmacovigilance Risk Assessment Committee: one year of public-health promotion and protection
PRAC, Last updated: 19/07/2013contraindication for the painkiller diclofenac. The PRAC found that the effects … found that the effects of diclofenac on the heart and circulation … should also be applied to diclofenac. The PRAC's full range of … -
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Press release: Updated advice on use of high-dose ibuprofen
CMDh, Last updated: 22/05/2015including COX-2 inhibitors and diclofenac. No increase in cardiovascular … including COX-2 inhibitors and diclofenac. No increase in cardiovascular … including COX-2 inhibitors and diclofenac. For diclofenac, the risk was estimated at … -
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Press release: European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH
Last updated: 25/03/2010Pharma GmbH, Clopidogrel Hexal, Clopidogrel Ratiopharm, Clopidogrel … Pharma GmbH: EPAR Clopidogrel Hexal: EPAR Clopidogrel ratiopharm … Pharma GmbH, Clopidogrel Hexal, Clopidogrel Ratiopharm … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018
CHMP, Last updated: 16/11/2018Name of medicine Diclofenac sodium spray gel 4% INN diclofenac List item … -
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National expert: Maria Luisa Casini, Italian Medicines Agency (updated)
- Declaration of interests - 39.31 KB | PDF
- Curriculum Vitae - 39.53 KB | PDF
– Raccomandazioni all’uso, reazioni avverse e trattamento … -
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Referral: Metamizole containing medicinal products
metamizole, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 20/03/2019, Last updated: 28/03/2019Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan … -
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Human medicine European public assessment report (EPAR): Zarzio (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,
, Revision: 23, Authorised, Last updated: 18/09/2023
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Press release: PRAC recommends updating advice on use of high-dose ibuprofen
PRAC, Last updated: 13/04/2015including COX-2 inhibitors and diclofenac. No increase in cardiovascular … including COX-2 inhibitors and diclofenac. No increase in cardiovascular … that of COX-2 inhibitors and diclofenac. The review was conducted … -
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Press release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 December 2014
CVMP, Last updated: 12/12/2014containing the substance diclofenac … containing the substance diclofenac. The procedure responds to … in the Union containing diclofenac. The Committee adopted by … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Acetylcysteine, paracetamol, phenylephrine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases; Oto-rhino-laryngology
PIP number: EMEA-003091-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral solution
Decision date: 31/12/2021, Last updated: 14/03/2023, Compliance check: Xtract infections Oral use HEXAL AG Email: enquiries.paediatrics@sandoz.com … application submitted by Hexal AG on 9 August 2021 under … decision is addressed to HEXAL AG, Industriestrasse 25 … -
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Press release: Press Release on the cardiovascular safety of non-selective NSAIDs
Last updated: 02/08/2005non-prescription products) are: Diclofenac, Etodolac, Ibuprofen, Indomethacin … non-prescription products) are: Diclofenac, Etodolac, Ibuprofen, Indomethacin … at through this review? Diclofenac, Etodolac, Ibuprofen, Indomethacin … -
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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: 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: 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