MHRA paediatric investigation plan
Celldemic (Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen)
MHRA paediatric investigation plan MHRA-101269-PIP01-23 · Agreement
Key facts
| PIP number | MHRA-101269-PIP01-23 |
|---|---|
| Product names | Celldemic, Audenz |
| Active substances | Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of zoonotic influenza |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Compliance check outcome | Full |
| 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: