MHRA paediatric investigation plan
Not available at present (Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA)
MHRA paediatric investigation plan MHRA-100637-PIP01-22 · Agreement
Key facts
| PIP number | MHRA-100637-PIP01-22 |
|---|---|
| Product names | Not available at present |
| Active substances | Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA, oligonucleotides that are directed against hepatitis B virus |
| Therapeutic areas | Infectious diseases |
| Conditions | Treatment of chronic hepatitis D infection |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | May 25, 2023 |
| 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: