MHRA paediatric investigation plan
(S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide ((S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide)
MHRA paediatric investigation plan MHRA-100234-PIP01-21 · Waiver
Key facts
| PIP number | MHRA-100234-PIP01-21 |
|---|---|
| Active substances | (S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide |
| Therapeutic areas | Cardiovascular Diseases |
| Conditions | Treatment of dilated cardiomyopathy due to lamin A/C gene mutations |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Nov 2, 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: