Abstract
Objective: Antibiotics approved for use several years ago may still have noninformative sections of their Summary of Product Characteristics (SPCs) (eg, therapeutic indications). This article describes the process of updating and improving these SPC texts in Sweden. Methods: In the renewal procedure for nationally approved antibiotics in Sweden, the marketing authorization holders were requested by the Medical Products Agency (MPA) to suggest a detailed indication text for each antibiotic, supported by an expert report. Updated pharmacodynamic texts, in accordance with the newly approved European Union guidelines, were also requested. The documentation was then scrutinized by the MPA. Results: After a dialogue between the MPA and the marketing authorization holders new SPC texts for the antibiotics were decided on by the MPA. Conclusion: The Swedish updating of the SPCs for antibiotics is a pioneering work in the European Union perspective. It may serve as an inspiration for drug authorities or other organizations within the European Union, to improve the standard of product information relating to a group of drugs.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
