Intended for UK patients and members of the public
Product Documentation
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintDiscontinued Other versions of this medicine may still be available. Information for reference purposes.
Product Documentation
Last updated on this site: 13 Aug 2024
Changes in the Summary of Product Characteristics and Package Leaflet in line with the reference product Tavanic. Editorial changes and updates in line with the QRD template.
- Type IB (C.1.2.a) variation application to update section 4.8 of SmPC and section 4 of PIL in line with the product information of the reference product (Tavanic 250/500 mg Film Coated Tablet; outcome of procedure UK/H/0203/001-003/II/072 MAH: Sanofi-Aventis Deutschland GmbH)
- Type IB (C.1.2.a) variation application to update section 4.4 and 4.8 of SmPC and corresponding section of PIL in line with the product information of the reference product (Tavanic 250/500 mg Film Coated Tablet; outcome of procedure DE/H/xxxx/WS/594; MAH: Sanofi-Aventis Deutschland GmbH)
- Type IB (C.1.2.a) variation application to update section 4.4, 4.7, 4.8 and 5.1 of SmPC and corresponding sections of PIL in line with the product information of the reference product (Tavanic 250/500 mg Film Coated Tablet; DCP procedure number: DE/H/5119/001-003/IB/096/G; MAH: Sanofi-Aventis Deutschland GmbH)
- Type IB (C.1.2.a) variation application to update section 4.4 and 4.8 of SmPC and section corresponding sections of PIL in line with the product information of the reference product (Tavanic 250/500 mg Film Coated Tablet; outcome of procedure DE/H/xxxx/WS/1098: DE/H/5119; MAH: Sanofi-Aventis Deutschland GmbH)
Last updated on this site: 23 May 2025
To update SmPC section 5.1 in line with EMA request - relocation of MIC data from PI.
SmPC sections updated: 5.1 & 10.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintFor any further assistance, please get in touch.