Actual Medicinal Product (AMP) Valdoxan 25mg tablets (Servier Laboratories Ltd)

Stability Information

(Some stability information inherited from generic)

Stability: Lack of data and/or stability concerns exist. MCA use may be acceptable but is likely to be off-label and require mitigation measures. Keep medicines in MCAs for the shortest time necessary. Generally, up to 5 weeks maximum unless otherwise specified, or up to 8 weeks if the MCA is airtight (sealed). Consider the risk of potency loss or dose variability and monitor for changes in efficacy or adverse effects after MCA initiation.
Notes: Moisture sensitive medicine. Store in airtight (sealed) MCA. Manufacturer recommends store in original container. No stability data in MCAs available.
Provenance: This recommendation is based on the products Valdoxan 25 mg film-coated tablets (Servier Laboratories Limited) and Agomelatine Zentiva 25mg film-coated tablets (Zentiva).
Generic: Agomelatine
Formulation: Agomelatine 25mg tablets