MHRA paediatric investigation plan
Simponi 50 mg solution for injection in pre-filled pen (GOLIMUMAB)
MHRA paediatric investigation plan MHRA-100361-PIP01-21-M01 (update) · Modification
Key facts
| PIP number | MHRA-100361-PIP01-21-M01 (update) |
|---|---|
| Product names | Simponi 50 mg solution for injection in pre-filled pen, Simponi 50 mg solution for injection in pre-filled syringe, Simponi 100 mg solution for injection in pre-filled pen, Simponi 45 mg/0.45 mL solution for injection in pre-filled pen, Simponi |
| Active substances | GOLIMUMAB |
| Therapeutic areas | Immunology -Rheumatology-Transplantation |
| Conditions | Treatment of ulcerative colitis |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Dec 7, 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: