MHRA paediatric investigation plan
Kalydeco (IVACAFTOR)
MHRA paediatric investigation plan MHRA-100844-PIP01-23-M01 (update) · Modification
Key facts
| PIP number | MHRA-100844-PIP01-23-M01 (update) |
|---|---|
| Product names | Kalydeco |
| Active substances | IVACAFTOR |
| Therapeutic areas | Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] |
| Conditions | Treatment of cystic fibrosis. |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Compliance check outcome | Full |
| Published | Aug 24, 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: