MHRA paediatric investigation plan
Ozempic (SEMAGLUTIDE)
MHRA paediatric investigation plan MHRA-100275-PIP01-21 · Agreement
Key facts
| PIP number | MHRA-100275-PIP01-21 |
|---|---|
| Product names | Ozempic, OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN, OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN, OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN |
| Active substances | SEMAGLUTIDE |
| Therapeutic areas | Gastroenterology-Hepatology |
| Conditions | Treatment of non-alcoholic steatohepatitis (NASH) |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | May 17, 2022 |
| 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: