In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
Європейська медична агенція (EMA) оприлюднила протокол засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 08 – 11 січня 2024 року. За результатами засідання було прийнято рішення про необхідність внесення змін з безпеки до реєстраційних матеріалів/інструкцій для медичного застосування лікарських засобів, що містять фолітропін бета (follitropin beta).
Follitropin beta (follitropin beta) – PUREGON – PSUSA/00001465/202305
Based on its assessment of the Periodic Safety Update Reports (PSURs), PRAC reviewed the benefit/risk balance of medicinal products containing follitropin beta and made the following recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk ratio of medicinal products containing follitropin beta for the approved indications remains unchanged.
- Nevertheless, the package insert should be updated to add anaphylactic reaction as an adverse reaction with a frequency of “not known”. Accordingly, the existing provisions of the package insert should be amended1.
1Update of the “Adverse reactions” section of the instructions for medical use. The risk assessment report and the PRAC recommendation are forwarded to the CHMP for a decision.
List of medicinal products containing follitropin beta that are authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 16.04.2024).
For the analysis of published information, the applicant must use the original text available at the following links:
