Code | 80931 | ||||||||||
MA number | 18/0562/09-S | ||||||||||
Product Form: | tbl flm 600x850 mg (blis. PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Merck Santé s.a.s, France | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 30.12.1973 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 14.07.2021 |