EMEA-003534-PIP01-23 - paediatric investigation plan
sitagliptin
dapagliflozin
PIPHuman
Maltese is available via eTranslation, the European Commission's machine translation service.
Translate to Maltese | Important information about machine translation
Key facts
- Active substance
- sitagliptin
- dapagliflozin
- Therapeutic area
- Metabolism and nutrition disorders
- Decision number
- P/0107/2024
- PIP number
- EMEA-003534-PIP01-23
- Pharmaceutical form(s)
- Film-coated tablet
- Condition(s) / indication(s)
- Treatment of type II diabetes mellitus
- Route(s) of administration
- Oral use
- Contact for public enquiries
Rontis Hellas Medical And Pharmaceutical Products S.A.
emakrodouli@pharosgr.gr
+30 2106664667- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date
- Compliance check done
- No