Code | 7114B | ||||||||||
MA number | 21/0208/98-S | ||||||||||
Product Form: | tbl mcp 14x5 mg (fľ.HDPE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | GlaxoSmithKline Trading Services Limited, Ireland | ||||||||||
Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 28.04.1998 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 29.05.2018 |