MHRA paediatric investigation plan
HOLOGENE 5 (Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA)
MHRA paediatric investigation plan MHRA-100371-PIP01-21 · Agreement
Key facts
| PIP number | MHRA-100371-PIP01-21 |
|---|---|
| Product names | HOLOGENE 5 |
| Active substances | Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA |
| Therapeutic areas | Dermatology |
| Conditions | Treatment of Junctional Epidermolysis Bullosa (JEB) |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Jun 30, 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: