MHRA paediatric investigation plan
Not available at present (2-[(4-{6-[(4-cyano-2-fluorobenzyl)oxy]pyridin-2-yl}piperidin-1-yl)methyl]-1-[(2S)-oxetan-2-ylmethyl]-1H-benzimidazole-6-carboxylic acid tris(hydroxymethyl)aminomethane salt (1:1))
MHRA paediatric investigation plan MHRA-100257-PIP01-21 · Agreement
Key facts
| PIP number | MHRA-100257-PIP01-21 |
|---|---|
| Product names | Not available at present |
| Active substances | 2-[(4-{6-[(4-cyano-2-fluorobenzyl)oxy]pyridin-2-yl}piperidin-1-yl)methyl]-1-[(2S)-oxetan-2-ylmethyl]-1H-benzimidazole-6-carboxylic acid tris(hydroxymethyl)aminomethane salt (1:1), PF-06882961 |
| Therapeutic areas | Endocrinology-Gynaecology-Fertility-metabolism |
| Conditions | Treatment of Type 2 Diabetes Mellitus |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| 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: