Impact of risk minimisation measures on the use of strontium ranelate in Europe: a multi-national cohort study in 5 EU countries by the EU-ADR Alliance

Author:

Berencsi K.,Sami A.,Ali M.S.,Marinier K.,Deltour N.,Perez-Gutthann S.,Pedersen L.,Rijnbeek P.,Van der Lei J.,Lapi F.,Simonetti M.,Reyes C.,Sturkenboom M.C.J.M.,Prieto-Alhambra D.ORCID

Funder

Servier

Publisher

Springer Science and Business Media LLC

Subject

Endocrinology, Diabetes and Metabolism

Reference20 articles.

1. CHMP. EMA/CHMP/257649/2013. Protelos and Osseor Strontium ranelate Procedure no. EMEA/H/C/560/PSU/031 and EMEA/H/C/561/PSU/031. Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisations. Vol. 44. 2013 [cited 2018 Aug 31]. Available from: www.ema.europa.eu

2. CHMP. EMA/112925/2014.Committee for Medicinal Products for Human Use (CHMP) Pharmacovigilance Risk Assessment Committee (PRAC) Protelos and Osseor Strontium renalate. 2014 [cited 2018 Aug 31]. Available from: www.ema.europa.eu

3. Norrelund H, Mazin W, Pedersen L (2014) Existing data sources for clinical epidemiology: Aarhus University Clinical Trial Candidate Database, Denmark. Clin Epidemiol 6:129–135

4. Filippi A, Vanuzzo D, Bignamini A, Mazzaglia G, Cricelli C, Catapano A (2005) The database of Italian general practitioners allows a reliable determination of the prevalence of myocardial infarction. Italian Heart J 6:311–314

5. Vlug AE, van der Lei J, Mosseveld BM, van Wijk MA, van der Linden PD, Sturkenboom MC et al (1999) Postmarketing surveillance based on electronic patient records: the IPCI project. Methods Inf Med 38(4–5):339–344

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