Based on the monitoring of information published on the official EMA website, in particular the PRAC safety recommendations for medicinal products for October 2025, the Center recommends that registration certificate holders make the relevant changes to the instructions for medical use of medicinal products containing the following active substances:
Domperidone (domperidone)
To the section “Special precautions for use”, “Contraindications”, add a contraindication for confirmed or suspected pheochromocytoma due to the risk of episodes of severe hypertension. Details at the link https://surl.li/bsjgeb
Semaglutide (semaglutide)
Update the “Special warnings and precautions for use” and “Adverse reactions” sections, adding a warning about the development of non-arteritic anterior ischemic optic neuropathy (NAION) and adding NAION to the adverse reactions section with the frequency “very rare”. Details at the link https://surl.lu/xghrpo
Enfortumab vedotin (enfortumab vedotin)
Update the sections “Special warnings and precautions for use” and “Adverse reactions” by adding a warning about pneumonia, and by including pneumonia and thrombocytopenia in the adverse reactions section with the frequency “common.” Details at the link https://surl.li/exonsv
Finasteride (finasteride) and Dutasteride (dutasteride)
The European Medicines Agency (EMA) recommends measures to minimize the risk of suicidal thoughts with the use of medicinal products containing finasteride (finasteride) and dutasteride (dutasteride) – information for patients and healthcare professionals. More details at the link https://surl.li/bfdbwh
Update the sections “Special warnings and precautions for use” in the part on Mood changes and depression. In the “Adverse reactions” section, add suicidal thoughts with the frequency “not known”. Details at the link https://surl.li/vfgdtg
Roxadustat (roxadustat)
Update the “Special warnings and precautions for use” and “Adverse reactions” sections, clarifying (or adding) a warning about thrombotic vascular events and adding cerebral infarction as an adverse reaction with the frequency “uncommon”. Details at the link https://surl.li/dxsyzw
Somatrogon (somatrogon)
Update the information in the section “Special precautions for use and doses” “Method of administration and doses”. Add lipoatrophy with a frequency of “not known” to the “Adverse reactions” section. Details at the link https://surl.li/xuclmq
Levosimendan (levosimendan)
Make changes to the section “Adverse reactions”, subsection “Immune system disorders”, adding a hypersensitivity reaction with the frequency “not known”. Details at the link https://surl.li/lzdfaq
Osimertinib (osimertinib)
Update the information in the sections “Special warnings and precautions for use” and “Adverse reactions” by adding the risk of hepatitis B virus reactivation with the frequency “not known.” Details at the link https://surl.li/ixwsyv
Dabrafenib (dabrafenib), Trametinib (trametinib)
Make changes to the section “Adverse reactions” by adding tattoo-associated skin reactions with the frequency “not known” when dabrafenib is used in combination with trametinib. Details at the link https://surl.li/gxdexc
Nicotine (nicotine)
Update the “Adverse reactions” section by adding atrial fibrillation as an adverse reaction with the frequency “not known”. Details at the link https://surl.li/bbuykk
Phosphocreatine (phosphocreatine)
Update the “Adverse reactions” section by adding urticaria (hives) as an adverse reaction with frequency “not known”. Details at https://surl.li/xqjsgz
The benefit/risk ratio of medicinal products remains unchanged provided the proposed changes to the instructions for medical use are made.
