MHRA paediatric investigation plan
DORAVIRINE (DORAVIRINE)
MHRA paediatric investigation plan MHRA-100111-PIP01-21 · Agreement
Key facts
| PIP number | MHRA-100111-PIP01-21 |
|---|---|
| Active substances | DORAVIRINE, Islatravir |
| Therapeutic areas | Infectious diseases |
| Conditions | Treatment of human immunodeficiency virus-1 (HIV-1) infection. |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Dec 17, 2021 |
| 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: