AP2 | Early Access post-MA
Early Access post-MA AP2 (Early Access post-MA) enables patients to [...]
Early Access post-MA AP2 (Early Access post-MA) enables patients to [...]
Added therapeutic benefit of a new treatment compared with standard [...]
Advanced therapy medicinal products (cell, gene, tissue-based) Advanced Therapy Medicinal [...]
Temporary authorisation granted for a cohort of patients with the [...]
Temporary authorisation granted for an individual patient on physician request [...]
EMA’s Committee for Advanced Therapies The Committee for Advanced Therapies [...]
Economic Committee for Health Products The Economic Committee for Health [...]
EMA Committee for Medicinal Products for Human Use The Committee [...]
Conditional Marketing Authorisation requiring further data Conditional Marketing Authorisation (CMA) [...]
Concerned Member State in an EU authorisation procedure. In decentralised [...]