Code | 4497D | ||||||||||
MA number | 30/0111/20-S | ||||||||||
Product Form: | tbl mod 30x75 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Neuraxpharm Bohemia s.r.o., Czechia | ||||||||||
Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 18.05.2020 |
Validity: | 18.05.2025 |
MA renewed: | Renewal application submitted |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 10.05.2022 |