EMEA-003572-PIP01-23 - paediatric investigation plan
sitagliptin
dapagliflozin
PIPHuman
Key facts
- Active Substance
- sitagliptin
- dapagliflozin
- Therapeutic area
- Endocrine disorders
- Decision number
- P/0196/2024
- PIP number
- EMEA-003572-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
Althera Laboratories Limited
Email: regulatory.eu@altherainc.com
Tel.: +353 1 906 0479- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date