Sofosbuvir
Medicine Compliance Aid Stability · New Medicines · Published , updated
24573011000001106
Medicine Compliance Aid Stability
Sovaldi · Gilead Sciences Ltd
Gilead Sciences Ltd
Sovaldi
Tablets 400mg
A1 · Amber 1 · Stability data is available in an alternative container (not CAs) that may be extrapolated to support storage in CAs.
No special precautions for storage
Does not require any special storage conditions
12th August 2015
New Medicines
Sovaldi · Chronic hepatitis C infection in children aged 3 to 11 years - new granule and 200mg tablet formulations
Information
Sovaldi
New formulation and licence extension / variation
Gilead Sciences
Gilead Sciences
Development and Regulatory status
Approved (Licensed)
Approved (Licensed)
None
Aug 20 · Licence extension and new formulation approved in the EU [3].
Apr 20 · EU positive opinion for a licence change to recommend use to treat chronic hepatitis C infection in children aged 3 to <12 years. The new indication is use in combination with other medicinal products for treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above. The CHMP also recommended the addition of a new 200 mg strength for the film-coated tablets and the introduction of a new pharmaceutical form, coated granules, which will be available in two strengths: 150 mg and 200 mg [1].
Category
Uracil nucleotide analogue
Prevalence of HCV infection in children and adolescents has been reported to vary from 0.05% to 0.36% in the US and Europe [2].
Chronic hepatitis C infection in children aged 3 to 11 years - new granule and 200mg tablet formulations
co-infected with HIV
Oral