Postmarketing withdrawal of human medicinal products because of adverse reactions in animals: a systematic review and analysis

Author:

Onakpoya Igho J.1ORCID,Heneghan Carl J.1,Aronson Jeffrey K.1ORCID

Affiliation:

1. Centre for Evidence-based Medicine, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter; University of Oxford; Oxford UK

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference52 articles.

1. European Medicines Agency Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders and changes to scope of European safety referrals http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/10/news_detail_001939.jsp&mid=WC0b01ac058004d5c1 2016

2. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis;Onakpoya;BMC Med,2015

3. Indonesia Ministry of Health Ministerial Decree (IDMHD) 682-PH-63B 1963

4. On the hazards of an exaggerated fear of drugs in pregnancy. Studies on the influence of hyperemesis gravidarum as well as antiemetics (meclizine, phenothiazine derivatives) on the incidence of malformations. [Article in German];Doering;Dtsch Med Wochenschr,1964

5. Meclozine and foetal malformations: a prospective study;Smithells;Br Med J,1964

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