MHRA paediatric investigation plan
Not available at present (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))
MHRA paediatric investigation plan MHRA-101115-PIP01-23 · Waiver
Key facts
| PIP number | MHRA-101115-PIP01-23 |
|---|---|
| Product names | Not available at present |
| Active substances | 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 Amyotrophic lateral sclerosis |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Apr 30, 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: