MHRA paediatric investigation plan
1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate (1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate)
MHRA paediatric investigation plan MHRA-100107-PIP01-21 · Waiver
Key facts
| PIP number | MHRA-100107-PIP01-21 |
|---|---|
| Active substances | 1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl… |
| Therapeutic areas | Haematology-Hemostaseology |
| Conditions | Treatment of polycythaemia vera |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Mar 18, 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: