MHRA paediatric investigation plan
1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro- (1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro-)
MHRA paediatric investigation plan MHRA-100980-PIP01-23 · Waiver
Key facts
| PIP number | MHRA-100980-PIP01-23 |
|---|---|
| Active substances | 1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro-, 2-(((S)-1-methylpyrrolidin-2-yl)methoxy)quinazolin-4-yl)-3-methylpiperazin-1-yl)prop-, 2-en-1-one adipate |
| Therapeutic areas | Oncology |
| Conditions | Treatment of non-small cell lung cancer |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Apr 30, 2024 |
| 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: