MHRA paediatric investigation plan
[(2R)-2,3-bis[[(Z)-octadec-9-enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride) ([(2R)-2,3-bis[[(Z)-octadec-9-enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride))
MHRA paediatric investigation plan MHRA-101059-PIP01-23 · Waiver
Key facts
| PIP number | MHRA-101059-PIP01-23 |
|---|---|
| Active substances | [(2R)-2,3-bis[[(Z)-octadec-9-enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride), Palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20) / Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20) / Palmitoyl-KSS-GQAEPDRAHYNIVTF (HPV-16 E7 43-57) / Palmitoyl-KSS-KKLLMGTLGIVCPICSQKP(HPV-16 E7 82-98)… |
| Therapeutic areas | Oncology |
| Conditions | Treatment of human papilloma virus (HPV) type 16 positive malignancies |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Apr 30, 2024 |
| 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: