The impact of risk minimization measures on compliance and prescribing practices of flupirtine in Germany-Reference-Cited by-同舟云学术

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

Published:2018-08-21 Issue:1 Volume:35 Page:33-40
ISSN:0300-7995
Container-title:Current Medical Research and Opinion
language:en
Short-container-title:Current Medical Research and Opinion

Author:

Kaplan Sigal¹^ORCID,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

Link

https://www.tandfonline.com/doi/pdf/10.1080/03007995.2018.1499507

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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3. Drug utilization patterns of flupirtine following implementation of risk minimization measures in Germany;Current Medical Research and Opinion;2019-04-23

4. Pharmacology and clinical applications of flupirtine: Current and future options;World Journal of Pharmacology;2019-01-15

5. Prescribers’ compliance is part of benefit-risk assessment of medicines and it can lead to failure of risk minimization measures and withdrawals of medicines;Current Medical Research and Opinion;2018-10-24