Code | 8543C | ||||||||||
MA number | 30/0260/18-S | ||||||||||
Product Form: | tbl flm 28x25 mg (blis.OPA/Al/PE/vysušovadlo/Al/PE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Teva B.V., Netherland | ||||||||||
Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
ATC: |
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Shelf life: | 18 | ||||||||||
Container: | blister OPA/Al/PE/desiccant/Al/PE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 17.08.2018 |
Pediatric warnings: | Yes |
PIL: | PIL_Agomelatín Teva_07.2021.pdf |
SPC: | SPC_Agomelatín Teva_04.2022.pdf |
Safety feature | Yes |
Data update: | 21.11.2022 |