Product information
- Published: November 17, 2020
- Last updated: November 17, 2020
All approved medicinal products must have product information, that is, the Summary of Product Characteristics for health care professionals, the package leaflet for the user and labelling describing written information and layout of the package.
When applying for marketing authorisation to the Swedish Medical Products Agency, the product information is attached for assessment. The product information must follow guidelines and templates.
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Swedish Medical Products Agency (Läkemedelsverket)
Opening hours: weekdays 8:00 am to 4:30 pm CET
Telephone: +46 (0)18-17 46 00
Email: registrator@lakemedelsverket.se