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CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information, co

Taking into account the PRAC Assessment Report on the PSUR(s) for botulinum toxin a - haemagglutinin complex, the scientific conclusions are as follows: Effectiveness studies of the educational materials of botulinum toxin a – haemagglutinin complex have been conducted in order to examine the relationship between the recommended and the actual clinical practice. As the results of these studies did not raise any unexpected findings on the safety or the use of the product, which is consistent with published literature for this class, the educational material are no longer necessary and should be discontinued for botulinum toxin a – haemagglutinin complex. Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the terms of the Marketing Authorisation(s) of medicinal products containing botulinum toxin a – haemagglutinin complex, were warranted. The CMDh agrees with the scientific conclusions made by the PRAC.


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