MHRA paediatric investigation plan
Not available at present (EMPAGLIFLOZIN)
MHRA paediatric investigation plan MHRA-101690-PIP01-24 · Waiver
Key facts
| PIP number | MHRA-101690-PIP01-24 |
|---|---|
| Product names | Not available at present |
| Active substances | EMPAGLIFLOZIN, Derivative of 3-phenyl-3H,4H,6H,7H-pyrano[3,4-d]imidazol-4-one (BI 690517) |
| Therapeutic areas | Cardiovascular Diseases |
| Conditions | Treatment of heart failure |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Mar 10, 2025 |
| MHRA record | cms.mhra.gov.uk |
About MHRA paediatric investigation plans
A paediatric investigation plan sets out the studies a company must run in children to support authorisation of a medicine in the UK, or records a waiver or deferral.
Source: UK Medicines and Healthcare products Regulatory Agency (MHRA). Contains public sector information licensed under the Open Government Licence v3.0 · Source date: