MHRA paediatric investigation plan
anti-alpha-synuclein recombinant humanised monoclonal antibody (Company code UCB7853) (anti-alpha-synuclein recombinant humanised monoclonal antibody (Company code UCB7853))
MHRA paediatric investigation plan MHRA-101493-PIP01-24 · Waiver
Key facts
| PIP number | MHRA-101493-PIP01-24 |
|---|---|
| Active substances | anti-alpha-synuclein recombinant humanised monoclonal antibody (Company code UCB7853) |
| Therapeutic areas | Neurology |
| Conditions | Treatment of Parkinson's disease |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Oct 28, 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: