Effectiveness of Risk Minimization Measures to Prevent Pregnancy Exposure to Mycophenolate-Containing Medicines in Europe

Author:

Madison Terri,Donner Barbara,Mutter Roger,Mingrino Roberto,Alvaro Giuseppe

Funder

F. Hoffmann-La Roche

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference15 articles.

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2. CellCept Summary of Product Characteristics and Package Leaflet, 31 August 2018. https://www.ema.europa.eu/documents/product-information/cellcept-epar-product-information_en.pdf . Accessed 30 Sep 2018.

3. CellCept Summary of Product Characteristics and Package Leaflet, 1998. https://ec.europa.eu/health/documents/community-register/1998/199810202869/anx_2869_en.pdf . Accessed 29 Apr 2019.

4. European Commission. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use, 2010.

5. European Medicines Agency, Guideline on good pharmacovigilance practices. Module XVI—risk minimisation measures: selection of tools and effectiveness indicators, 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/03/WC500224576.pdf . Accessed 30 Sep 2018.

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