Code | 3440E | ||||||||||
MA number | 18/0094/23-S | ||||||||||
Product Form: | tbl flm 30x50 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | HCS BV, Belgium | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 15.05.2023 |
Validity: | 15.05.2028 |
PIL: | PIL_Sitagliptin HCS 25 mg, 50 mg, 100 mg tbl flm_08.2024.pdf |
SPC: | SPC_Sitagliptin HCS 25 mg, 50 mg, 100 mg tbl flm_08.2024.pdf |
Safety feature | Yes |
Data update: | 16.05.2023 |