MHRA paediatric investigation plan
ABBV-CLS-7262 (ABBV-CLS-7262)
MHRA paediatric investigation plan MHRA-101171-PIP01-23 · Agreement
Key facts
| PIP number | MHRA-101171-PIP01-23 |
|---|---|
| Active substances | ABBV-CLS-7262, Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1) |
| Therapeutic areas | Neurology |
| Conditions | Treatment of vanishing white matter disease |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Jun 24, 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: