Based on the results of monitoring safety data for medicinal products on the official EMA website, in particular, the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC), the Center recommends that marketing authorization holders amend the instructions for medical use of medicinal products with the following active substances:
Dorzolamide (dorzolamide)
Add photophobia as an adverse reaction with frequency "unknown". More details at the link https://surl.li/qbekbu
Amlodipine/atorvastatin (amlodipine/atorvastatin)
Add a warning regarding the increased risk of myopathy and/or rhabdomyolysis when used concomitantly with daptomycin. Add lichenoid reaction as an adverse reaction with frequency "rare". More details at the link https://surl.li/xrxpak
Cefazolin (cefazolin); cefazolin, lidocaine (cefazolin, lidocaine hydrochloride)
Clarify the "Special precautions for use" section by adding "hypersensitivity" – information on reported cases of Kounis syndrome arising from the cardiovascular system as a consequence of an allergic reaction or hypersensitivity reaction. Add "Cardiac disorders" Kounis syndrome as an adverse reaction with frequency "unknown". More details at the link https://surl.li/cujxuf
Gabapentin (gabapentin)
Clarify "Special precautions for use" by adding a warning regarding exacerbation of myasthenia gravis and adding myasthenia gravis as an adverse reaction with frequency "unknown". Amend the warning regarding withdrawal reactions after dose reduction. More details at the link https://surl.li/rpcrwp
Testosterone (testosterone)
Add information on interaction with sodium-dependent glucose cotransporter 2 inhibitors and on increased haemoglobin and haematocrit levels. Amend the warning on preventing accidental ingestion of the medicinal product by domestic animals to read preventing accidental ingestion of the medicinal product by domestic animals. More details at the link https://surl.li/htslpl
Varicella vaccine (live) [varicella vaccine (live)]
Amend the warning regarding the limitation of clinical trial data for persons at increased risk of severe chickenpox. Remove the recommendation on a fixed waiting period between discontinuation of immunosuppressive therapy/chemotherapy and administration of live attenuated vaccines, such as Varilrix [varicella vaccine (live)]. For more details, follow the link https://surl.li/lfgxbw
Pegylated liposomal doxorubicin
Add to the section "Adverse reactions", subsection "Renal and urinary disorders" thrombotic microangiopathy with kidney-limited involvement, with frequency "unknown". For more details, follow the link https://surl.lu/mwfyfr
Bevacizumab
Add to the section "Adverse reactions" hyaline occlusive glomerular microangiopathy as an adverse reaction with frequency "unknown". For more details, follow the link https://surl.li/hivvek
Ribociclib
Amend the note on hepatotoxicity regarding the number of cases of autoimmune hepatitis. Clarify that the adverse reactions listed in the instructions for medical use include data obtained in the post-registration period. For more details, follow the link https://surl.li/ngcytc
The benefit/risk ratio of the medicinal products remains unchanged provided the proposed amendments to the instructions for medical use are made.
