The impact of risk minimization measures on compliance and prescribing practices of flupirtine in Germany

Author:

Kaplan Sigal1ORCID,Ehlken Birgit2,Hamann Xenia3

Affiliation:

1. Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel;

2. IQVIA (formerly IMS Health), Munich, Germany;

3. Ratiopharm GmbH (an affiliate of Teva Pharmaceuticals Europe BV), Ulm, Germany

Publisher

Informa UK Limited

Subject

General Medicine

Reference17 articles.

1. Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study

2. Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years

3. Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial

4. European Medicines Agency. Notification of a referral under Article 107i of Directive 2001/83/EC. London, UK: EMA; February 28, 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Flupirtine-containing_medicines/Procedure_started/WC500139756.pdf [Last accessed 28 September 2017]

5. European Medicines Agency: EMA/404308/2013. Assessment report for flupirtine containing medicinal products. London, UK: EMA; September 24, 2013; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Flupirtine-containing_medicines/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee/WC500146103.pdf [Last accessed 24 September 2017]

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