On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Fortacin. The marketing authorisation holder for this medicinal product is Recordati Ireland Ltd.
This change is based on the fact that CHMP agreed that the criteria for classifying a medicine as subject to medical prescription as laid down in the European Commission Guideline do not apply to Fortacin. Therefore, the Committee recommended that the change in the supply classification is approvable.
For information, the full indication for Fortacin is as follows:
“Fortacin is indicated for the treatment of primary premature ejaculation in adult men.”
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
|Agency product number||
|International non-proprietary name (INN) or common name||
Sexual Dysfunction, Physiological
|Date opinion adopted||