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 Pharmacovigilance Risk Assessment Committee (PRAC), based on the evaluation of periodic safety update reports (PSURs) for medicinal products containing terbinafine, PSUSA/00002896/202509, reached the following conclusions.
In view of the available data on thrombotic thrombocytopenic purpura from literature sources and spontaneous reports, which in some cases contain information on a close temporal relationship, a case with a positive response to withdrawal of the medicinal product (de-challenge), and in view of a plausible mechanism of action, the PRAC considers that a causal relationship between the use of terbinafine and thrombotic thrombocytopenic purpura is at least reasonably possible. The PRAC concluded that the instructions for medical use of medicinal products containing terbinafine for systemic use should be amended accordingly.
Having considered the PRAC recommendations, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the overall conclusions of the PRAC and the grounds for the recommendations.
Based on the scientific conclusions on terbinafine, the CMDh considers that the benefit/risk balance of medicinal products containing terbinafine remains unchanged, provided that the proposed amendments are made to the instructions for medical use.
Changes to be made to the relevant sections of the instruction for medical use (new text underlined and in bold).
“Special precautions for use” section
The warning should be worded as follows:
…
Hematologic effects
Very rare cases of blood dyscrasias (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported in patients using [medicinal product]. The etiology of any blood dyscrasias occurring in patients using [medicinal product] should be assessed, and a change in the treatment regimen should be considered, including discontinuation of treatment with [medicinal product].
Cases of thrombotic thrombocytopenic purpura (TTP), some of them fatal, have been reported with the use of terbinafine. TTP is characterized by thrombocytopenia and microangiopathic hemolytic anemia and may be accompanied by neurological symptoms, impaired renal function, or fever. If TTP is suspected, use of [the medicinal product] should be discontinued immediately, a diagnostic examination should be performed, and treatment of TTP should be started. If TTP is confirmed, use of [the medicinal product] should be discontinued.
“Adverse reactions” section
The following adverse reaction should be added to the System Organ Class (SOC) “Blood and lymphatic system disorders” with the frequency “not known”:
Thrombotic thrombocytopenic purpura
List of medicinal products containing terbinafine and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 17.08.2026). (14 KB) (Downloaded: 01.09.2026 12:41:14)
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:
