Ofev ( nintedanib - European Medicines Agency
Ofev (nintedanib) EMA/114463/2020 Page 3/3 As for all medicines, data on the use of Ofev are continuously monitored Side effects reported with Ofev are carefully evaluated and any necessary action taken to protect patients Other information about Ofev Ofev received a marketing authorisation valid throughout the EU on 14 January 2015
Ofev - European Medicines Agency
Fibrosis (IPF) Ofev was designated as an orphan medicinal product on 26 April 2013 The applicant for this medicinal product is m International GmbHBoehringer Ingelhei They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion
EN EN - European Commission
EUROPEAN COMMISSION Brussels, 17 4 2020 C(2020)2574 (final) COMMISSION IMPLEMENTINGof 17 4 2020 DECISION amending the marketing authorisation granted by Decision C(2015)234(final) for “Ofev - Nintedanib”, an orphan medicinal product for human use (Text with EEA relevance) (ONLY THE GERMAN TEXT IS AUTHENTIC)
Summary of the risk management plan (RMP) for Ofev (nintedanib)
Summary of the risk management plan (RMP) for Ofev (nintedanib) This is a summary of the risk management plan (RMP) for Ofev, which details the measures to be taken in order to ensure that Ofev is used as safely as possible For more information on RMP summaries, see here
EUROPEAN COMMISSION
EUROPEAN COMMISSION Bruxelles, 15 1 2015 C(2015)234 (final) COMMISSION IMPLEMENTINGof 15 1 2015 DECISION granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Ofev - Nintedanib", an orphan medicinal product for human use (Text with EEA relevance) (ONLY THE GERMAN TEXT IS AUTHENTIC)
Safety news - WHO
Nintedanib: avoid in hepatic function disorder Japan – The PMDA has recommended that the use of nintedanib (Ofev®) should be avoided in patients with moderate to severe hepatic function disorder (Child-Pugh B and C) unless treatment with this drug is deemed necessary The results from the clinical pharmacokinetic study,
Australian public assessment report for
Ofev/Vargatef (nintedanib (as esilate)) 100 mg and 150 mg, soft capsule, blister pack, for the following extension of indications: Ofev/Vargatef is also indicated for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
European consensus statements for interstitial lung disease
Nintedanib had no effect on skin score The European consensus state-ments seem to rate nintedanib equally with immune suppressive therapy in the treatment of SSc-ILD We think there is a need for long-term data on nintedanib in SSc-ILD treatment and a relevant comparison of mycophenolate mofetil with nintedanib and other treatments
AusPAR Attachment 2: Extract from the Clinical Evaluation
the use of medicines and medical devices • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices TGA investigates reports received by it to determine any necessary regulatory action • To report a problem with a medicine or medical device, please see the information on
D r u g N e w s - Drug Office
Vargatef Capsules 150mg (HK-64396), Ofev Capsules 100mg (HK-64604) and Ofev Capsules 150mg (HK-64605) All products are registered by Boehringer Ingelheim (HK) Ltd, and are prescription-only medicines As on 5 January 2018, DH has received 3 cases of ADR related to nintedanib, but none of them was related to liver injury
[PDF] Note Immatriculation Vs Identite - Gisti
[PDF] Procédure d 'attribution du Numéro d 'Identification Statistique NIS
[PDF] Procédure d 'attribution du Numéro d 'Identification Statistique NIS
[PDF] NITE System Diagnostic Table - Bergstrom
[PDF] Grille de classification - cnt-soorg
[PDF] Accord du 10 juin 2016 - UIMM
[PDF] Rapport de référencement du cadre luxembourgeois des - MENlu
[PDF] Niveau A1 - compétences et descripteurs - Académie de Nancy-Metz
[PDF] questions - Université Paris-Dauphine
[PDF] DESCRIPTEURS NIVEAU B2 du Cadre européen commun de
[PDF] Cnam - Communication en langues étrangères - BULATS
[PDF] bulats - British Council
[PDF] LA SCOLARITÉ EN FRANCE
[PDF] exercices corriges photon - Picassciences