MHRA paediatric investigation plan
Odefsey (RILPIVIRINE)
MHRA paediatric investigation plan MHRA-100669-PIP01-22-M02 (update) · Waiver
Key facts
| PIP number | MHRA-100669-PIP01-22-M02 (update) |
|---|---|
| Product names | Odefsey |
| Active substances | RILPIVIRINE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
| Therapeutic areas | Infectious diseases |
| Conditions | Treatment of human immunodeficiency virus (HIV-1) infection |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Jan 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: