MHRA paediatric investigation plan
Not available at present ((5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4-(prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6-(propan-2-yl)-11,12-dihydro-4H-1,18-(ethanediylidene)pyrido[4,3-e]pyrimido[1,6- g][1,4,7,9]benzodioxadiazacyclododecin-4-one (MK-1084))
MHRA paediatric investigation plan MHRA-101564-PIP01-24 · Waiver
Key facts
| PIP number | MHRA-101564-PIP01-24 |
|---|---|
| Product names | Not available at present |
| Active substances | (5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4-(prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6-(propan-2-yl)-11,12-dihydro-4H-1,18-(ethanediylidene)pyrido[4,3-e]pyrimido[1,6… |
| Therapeutic areas | Oncology |
| Conditions | Treatment of all solid and haematological malignancies |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Jan 6, 2025 |
| 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: