The regulatory body said on Tuesday that conditional registration is established to confirm the results of the Phase 3 clinical efficacy study.
The registration granted will be valid for three years from the date of issuance of the registration certificate.
Neuro-Epo, developed by the Molecular Engineering Center in collaboration with other BioCubaFarma institutions, is a nasal formulation.
The results of the Phase II-III clinical trial with this product in patients with mild and moderate Alzheimer’s disease were encouraging, as recently reported by CIM authorities.
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