Code | 7089C | ||||||||||
MA number | 21/0070/18-S | ||||||||||
Product Form: | tbl flm 56x150 mg (bls.PVC/PVDC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Belupo lijekovi i kozmetika d.d., Croatia | ||||||||||
Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
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: | 20.02.2018 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_MIDZA_11.2022.pdf |
SPC: | SPC_MIDZA_ 11.2022.pdf |
Safety feature | Yes |
Data update: | 23.06.2022 |