MHRA paediatric investigation plan
2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3- (2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3-)
MHRA paediatric investigation plan MHRA-100432-PIP01-22 · Agreement
Key facts
| PIP number | MHRA-100432-PIP01-22 |
|---|---|
| Active substances | 2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3-, (tetrahydro-2H-pyran-4-yl)-3-azabicyclo[3.1.0]hexan-1-, yl)phenyl)nicotinamide fumarate dihydrate |
| Therapeutic areas | Endocrinology-Gynaecology-Fertility-metabolism |
| Conditions | Treatment of fibrodysplasia ossificans progressiva |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Dec 7, 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: