Code | 6179E | ||||||||||
MA number | 18/0028/24-S | ||||||||||
Product Form: | tbl mod 28x50 mg/1000 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | TEVA Pharmaceuticals Slovakia s.r.o., Slovakia | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10b fixed combination application |
MA issued: | 17.05.2024 |
Validity: | 17.05.2029 |
SPC: | SPC_Sitagliptin/Metformin Teva CR 50 mg/1000 mg_tbl mod_05/2024_REG.pdf |
PIL: | PIL_Sitagliptin/Metformin Teva CR 50 mg/1000 mg_tbl mod_05/2024_REG.pdf |
Safety feature | Yes |
Data update: | 28.05.2024 |