MHRA paediatric investigation plan
EVICEL, Solution for sealant (Human Fibrinogen (INN) / Human Thrombin (INN))
MHRA paediatric investigation plan MHRA-100083-PIP01-21-M01 (update) · Modification
Key facts
| PIP number | MHRA-100083-PIP01-21-M01 (update) |
|---|---|
| Product names | EVICEL, Solution for sealant, EVARREST, Sealant matrix (withdrawn EU MAA), EVICEL |
| Active substances | Human Fibrinogen (INN) / Human Thrombin (INN), HUMAN THROMBIN, HUMAN FIBRINOGEN |
| Therapeutic areas | Other: blood-derived topical haemostats |
| Conditions | Treatment of: haemorrhage from a surgical procedure, CSF leakage from a neurosurgical procedure |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Nov 15, 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: