In accordance with paragraph 8 of section IV of the Procedure for Conducting Expert Evaluation, the applicant must make amendments to the package insert of the medicinal product when new data are obtained, including bringing the package insert into line with the approved package insert of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
On the basis of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing bleomycin (bleomycin), the Pharmacovigilance Risk Assessment Committee (PRAC) made the following conclusions.
In view of the available data on acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) from the literature, spontaneous reports and the plausible mechanism of action, the PRAC considers that a relationship between the use of bleomycin and the occurrence of acute myeloid leukemia/myelodysplastic syndrome when used in combination with other antineoplastic agents cannot be excluded. The PRAC concluded that the instructions for medical use of medicinal products containing bleomycin should be amended accordingly.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the scientific conclusions drawn by PRAC.
Based on the scientific conclusions, the CMDh considers that the benefit/risk balance of medicinal products containing bleomycin (bleomycin) remains unchanged, subject to the appropriate amendments being made to the instructions for medical use.
Changes that should be included in the relevant sections of the instructions for medical use (new text underlined in bold, deleted text struck through).
Section “Special warnings and precautions for use”
Blood and lymphatic system disorders
Acute myeloid leukemia and myelodysplastic syndrome have been reported in patients receiving concomitant treatment with bleomycin and other antineoplastic agents.
List of medicinal products containing bleomycin (bleomycin) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 08.02.2023). (10 KB) (Uploaded: 23.02.2023 08:14:06)
For the analysis of the published information, the applicant must use the original text available at the link:
