In use product safety assessment report for Alkindi® (hydrocortisone) granules in capsules for opening

Alkindi® granules in capsules for opening is the first hydrocortisone product licensed solely for paediatric use for replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old). This review summarises practical in-use safety considerations associated with the introduction of Alkindi®. The addition of this new product to the UK market with its unusual presentation ‘granules in capsules for opening’ raises some safety concerns.

The UKMI product safety assessment group would appreciate your views on the usefulness of this assessment. We have devised a short survey which we would appreciate you completing, it should take approximately 10 minutes to complete. Click here – https://www.surveymonkey.com/r/UKMiProductSafetyAssessments  – to complete the survey.

Endocrine system disordersHydrocortisonePaediatric and neonatal medicine

Attachments