MHRA paediatric investigation plan
Not available at present (2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [1,2,4]triazin-6-yl]-1H-pyrazol-1-yl}ethan-1-ol)
MHRA paediatric investigation plan MHRA-101178-PIP01-23 · Waiver
Key facts
| PIP number | MHRA-101178-PIP01-23 |
|---|---|
| Product names | Not available at present |
| Active substances | 2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [1,2,4]triazin-6-yl]-1H-pyrazol-1-yl}ethan-1-ol |
| Therapeutic areas | Haematology-Hemostaseology, Oncology |
| Conditions | Treatment of mastocytosis |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Aug 15, 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: