MHRA paediatric investigation plan
DAPAGLIFLOZIN (DAPAGLIFLOZIN)
MHRA paediatric investigation plan MHRA-100243-PIP01-21 · Waiver
Key facts
| PIP number | MHRA-100243-PIP01-21 |
|---|---|
| Active substances | DAPAGLIFLOZIN, 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977) |
| Therapeutic areas | Cardiovascular Diseases |
| Conditions | Prevention of cardiovascular events in patients with chronic heart failure |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Oct 21, 2022 |
| 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: