The State Expert Center of the Ministry of Health of Ukraine recommends supplementing the instructions for medical use of medicinal products containing the active substances: mifepristone, ceftriaxone, cobimetinib, vemurafenib, cefotaxime.
Reports on this have been published on the Center's website with reference to information from the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA): http://surl.li/rmenl
The recommendations are intended to ensure the safety of medicinal products in accordance with the latest medical standards and data.
Mifepristone – based on scientific conclusions, the PRAC considers that the benefit/risk balance of medicinal products containing mifepristone remains unchanged provided that the instructions are updated. In particular, the instructions should be supplemented with a warning on cautious use in women with cardiovascular disease risk factors (for example, age over 35 years, chronic smoking, hyperlipidemia, diabetes) or existing cardiovascular diseases: http://surl.li/sgfmf
Ceftriaxone – based on the analysis of the literature and spontaneous reports, the PRAC considers that the benefit/risk balance of medicinal products containing ceftriaxone remains unchanged. However, it recommends updating the instructions for medical use in view of new information on hypersensitivity reactions and cardiovascular complications. In particular, regarding a possible association between ceftriaxone and Kounis syndrome: http://surl.li/sgflo
Cobimetinib, vemurafenib – PRAC recommends amending the instructions for medical use of medicinal products containing cobimetinib and vemurafenib. The changes concern the “Adverse reactions” section; in particular, the adverse reaction “stomatitis” with a frequency of “common” must be added for both active substances: http://surl.li/sgfjv
Cefotaxime – PRAC recommends amending the instructions for medical use to describe severe cutaneous adverse reactions that may have life-threatening consequences. When prescribing this medicinal product, physicians should be particularly attentive to the symptoms and signs of these reactions and, if necessary, discontinue treatment immediately: http://surl.li/sgfjm
To analyze the published information, holders of registration certificates for medicinal products must use the original text available at the link:
https://www.ema.europa.eu/en/documents/other/prac-recommendations-signals-adopted-8-11-january-2024-prac-meeting_en.pdf
https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-8-11-january-2024-prac_en.pdf
Reminder: In accordance with paragraph 8 of Section IV of the Procedure for Conducting Expert Evaluation, the applicant (the holder of the registration certificate for a medicinal product) must make changes to the instructions for medical use of the medicinal product when new data are obtained, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and must ensure that the information on the medicinal product corresponds to current scientific knowledge.
