The Pharmacovigilance Risk Assessment Committee (PRAC), based on the evaluation of Periodic Safety Update Reports (PSURs) for medicinal products containing ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen caffeine (hereinafter, ibuprofen), made the following conclusions:
In view of the available data from the literature and spontaneous reports on the risk of developing photosensitivity with ibuprofen use, which included 33 cases and had a close temporal relationship, and in view of the likely mechanism of action, the PRAC lead country considers a causal relationship between ibuprofen and the development of photosensitivity to be possible. PRAC recommends that registration certificate holders of medicinal products containing ibuprofen that do not have the specified adverse reaction of photosensitivity in the core safety information make changes to the following section of the instructions for medical use:
- “Adverse reactions” – photosensitivity reactions with frequency “unknown”
List of medicinal products containing ibuprofen that are authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 25.11.2020). (29 KB) (Uploaded: 25.01.2021 08:42:49)
Linkhttps://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-28-september-1-october-2020_en.pdf
