Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics-Reference-Cited by-同舟云学术

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Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics

Published:2024-03-31 Issue:3 Volume:38 Page:205-216
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Herzig Markus^ORCID,Eisenhofer Simone^ORCID,Ruschkowski Meike^ORCID,Neubert Antje^ORCID,Bertsche Astrid^ORCID,Bertsche Thilo^ORCID,Neininger Martina Patrizia^ORCID

Funder

Universität Leipzig

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s40290-024-00519-w.pdf

Reference45 articles.

1. European Medicines Agency. Glossary of regulatory terms. 2023. https://www.ema.europa.eu/en/glossary/label-use. Accessed 11 Feb 2024.

2. Paul-Ehrlich-Institut. Glossary. 2019. https://www.pei.de/EN/service/glossary/Functions/glossary.html?nn=165874&cms_lv2=165830. Accessed 6 Oct 2023.

3. German Federal Institute for Drugs and Medical Devices. Expertengruppen Off-Label. 2023. https://www.bfarm.de/DE/Arzneimittel/Zulassung/Zulassungsrelevante-Themen/Expertengruppen-Off-Label/_node.html. Accessed 6 Oct 2023.

4. Kimland E, Odlind V. Off-label drug use in pediatric patients. Clin Pharmacol Ther. 2012;91:796–801. https://doi.org/10.1038/clpt.2012.26.

5. Knopf H, Wolf I-K, Sarganas G, Zhuang W, Rascher W, Neubert A. Off-label medicine use in children and adolescents: results of a population-based study in Germany. BMC Public Health. 2013;13:631. https://doi.org/10.1186/1471-2458-13-631.

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