| Code | 3439E | ||||||||||
| MA number | 18/0094/23-S | ||||||||||
| Product Form: | tbl flm 28x50 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: |
|
||||||||||
| 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
|
| Dokument: |
VHS_Sitagliptin HCS_SK_H_0277_001-003_DC.pdf
|
| Dokument: |
VHS_Sitagliptin HCS_SK_H_0277_001-003_DC_sumár.pdf
|
| Safety feature | Yes |
| Data update: | 16.05.2023 |
