Code | 8281D | ||||||||||
MA number | 21/0220/21-S | ||||||||||
Product Form: | tbl flm 90x800 mg (blis. Al/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 18.08.2021 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: |
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PIL: |
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Safety feature | Yes |
Data update: | 22.04.2022 |