Impact of EU risk assessment process and administrative regulations for manufacturers of combined hormonal contraceptive prescribing. An analysis of developments in Germany and the implications-Reference-Cited by-同舟云学术

Impact of EU risk assessment process and administrative regulations for manufacturers of combined hormonal contraceptive prescribing. An analysis of developments in Germany and the implications

Published:2018-11-30 Issue:4 Volume:35 Page:697-704
ISSN:0300-7995
Container-title:Current Medical Research and Opinion
language:en
Short-container-title:Current Medical Research and Opinion

Author:

Selke Krulichová Iva¹^ORCID,Selke Gisbert W.²^ORCID,Eichler Uwe²,Lappe Veronika³,Godman Brian⁴⁵⁶⁷^ORCID,Schubert Ingrid³^ORCID

Affiliation:

1. Department of Medical Biophysics, Faculty of Medicine in Hradec Králové, Charles University, Hradec Králové, Czech Republic;

2. AOK Research Institute (WIdO), Berlin, Germany;

3. PMV research group, Clinic and Policlinic for Psychiatry, Psychosomatics and Psychotherapy of Children and Adolescents, Cologne University, Germany;

4. Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University, Glasgow, UK;

5. Health Economics Centre, Liverpool University Management School, Liverpool, UK;

6. Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institute, Karolinska University Hospital Huddinge, Stockholm, Sweden;

7. Department of Public Health Pharmacy and Management, School of Pharmacy, Sefako Makgatho Health Sciences University, Garankuwa, South Africa

Funder

Federal Institute for Drugs and Medical Devices

Publisher

Informa UK Limited

Subject

General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/03007995.2018.1541317

Reference26 articles.

1. Boeschen D, Günther J, Chytrek D, et al. Pillenreport 2015. Ein Statusbericht zu oralen Kontrazeptiva. Bremen: Universität Bremen; 2015. 63 p

2. European Medicines Agency. Benefits of combined hormonal contraceptives (CHC) continue to outweigh risks. Product information updated to help women make informed decisions about their choice of contraception. EMA 35464/2014. London: EMA; January 16, 2014

3. Bundesinstitut für Arzneimittel und Medizinprodukte. Abwehr von Gefahren durch Arzneimittel. Hier: Umsetzung des Durchführungsbeschlusses der Kommission K (2014)307 betreffend die Zulassung der Humanarzneimittel „Kombinierte hormonale Kontrazeptiva “gemäß Artikel 31 der Richtlinie 2001/83/EG (KHK-Bescheid an pharmazeutische Unternehmer). Bonn: 2014. Available at: https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/Pharmakovigilanz/Risikoinformationen/RisikoBewVerf/g-l/khk_bescheid.pdf?__blob=publicationFile&v=2 [Last accessed November 5, 2017]

4. Bundesinstitut für Arzneimittel und Medizinprodukte. Patienteninformation. Bonn: 2014. Available at: https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/Pharmakovigilanz/Risikoinformationen/RI_rhb/2014/rhb-khk-pi-card.pdf?__blob=publicationFile&v=3 [Last accessed November 5, 2017]

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