Code | 0813E | ||||||||||
MA number | 18/0128/22-S | ||||||||||
Product Form: | tbl flm 100x1000 mg (blis.PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Zentiva, k.s., Czechia | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | blister PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 16.05.2022 |
Validity: | 16.05.2027 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: |
|
SPC: |
|
Safety feature | Yes |
Data update: | 18.05.2022 |