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.
The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on March 09 – 12, 2026. Following the meeting, a decision was made that safety-related changes need to be introduced to the registration materials/instructions for medical use of medicinal products containing perampanel.
Perampanel (perampanel) – FYCOMPA – PSUSA/00009255/202507
Based on the evaluation of periodic safety update reports (PSURs), the PRAC reviewed the benefit/risk balance of the use of the medicinal product FYCOMPA (perampanel) and provided relevant recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk balance of the medicinal product FYCOMPA (perampanel) for the approved indications remains unchanged.
- At the same time, the instructions for medical use should be updated by amending the existing wording on overdose with perampanel (perampanel) and adding vomiting to the list of adverse reactions observed in overdose. Thus, the current provisions of the instructions for medical use must be amended1.
- In the next PSUR, the registration certificate holder (RCH) should continue to carefully monitor cases of death, as well as pediatric cases associated with the use of the medicinal product outside the approved indications (off-label use) or in age groups not provided for by the approved indications. In addition, the RCH should provide a cumulative review of cases of bradycardia and related preferred terms [PTs – preferred terms (PT)] from all sources, including a discussion of the possible mechanism of action and a separate analysis/discussion of cases in the context of overdose, and consider the need for further updating of the instructions for medical use. The RCH should also provide a cumulative review of cases of toxic epidermal necrolysis (TEN) and consider whether an update of the instructions for medical use is necessary.
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1Update of the “Overdose” section of the instructions for medical use. The risk assessment report and PRAC recommendation are forwarded to the CHMP for decision.
Scientific conclusions of the EMA Committee for Medicinal Products for Human Use (CHMP) and grounds for amending the registration materials
Taking into account the PRAC assessment report on PSURs for medicinal products containing perampanel (perampanel), the scientific conclusions of the PRAC are as follows.
In view of cases of overdose obtained from spontaneous reports and the scientific literature, a causal relationship between the use of perampanel (perampanel) and the occurrence of vomiting in the context of overdose is at least a reasonable possibility. The instructions for medical use of medicinal products containing perampanel (perampanel) must be amended accordingly.
Having reviewed the PRAC recommendations, the CHMP agreed with the overall conclusions and grounds for the recommendations.
Based on the scientific conclusions on perampanel, the CHMP considers that the benefit/risk balance of medicinal products containing perampanel remains unchanged, subject to the proposed changes being made to the instructions for medical use.
Comprehensive and up-to-date information on an individual medicinal product (summary of product characteristics, post-registration procedural steps, RMP summary, additional risk minimization measures, etc.) that is registered under the centralized procedure can be found in the Human medicines European public assessment report (EPAR) on the EMA website.
List of medicinal products containing perampanel (perampanel) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 11.06.2026). (13 KB) (Downloaded: 22.06.2026 06:45:22)
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS:
