Based on monitoring of the official EMA website (PRAC) on the safety of medicinal products during August 2025, the Center recommends that registration certificate holders make changes to the instructions for medical use of products with the following active substances:
Benzydamine (benzydamine)
Amend the section “Use during pregnancy or breastfeeding” in accordance with the specified wording. More details at the link https://surl.li/izxoxt
Sumatriptan (sumatriptan), Naproxen/Sumatriptan (naproxen/sumatriptan)
Make changes regarding breastfeeding, namely the relative infant dose. Supplement with information on breast pain in breastfeeding women as an adverse reaction with the frequency “rare”. More details at the link https://surl.lu/picbqk
Abemaciclib (abemaciclib)
Make changes by adding keratitis as an adverse reaction with the frequency “uncommon”. More details at the link https://surli.cc/ygmgpn
Levosimendan (levosimendan)
Make the change by adding “hypersensitivity” as an adverse reaction with the frequency “not known”. For details, follow the link https://surl.lt/rmgpfx
Denosumab (denosumab)
Amend the section “Special warnings and precautions for use” by adding a warning about a decrease in bone mineral density after discontinuation. For details, see the link https://surl.li/cjstxk
Doravirine/Lamivudine/Tenofovir disoproxil (doravirine/lamivudine/tenofovir disoproxil)
Amend the warning on effects on bone tissue by adding the adverse reaction “decreased bone mineral density” with the frequency “common”. More details at the link https://surl.li/iferln
The benefit/risk ratio of medicinal products remains unchanged provided the proposed changes to the instructions for medical use are made.
