dm+d

24573011000001106

Medicine Compliance Aid Stability

SovaldiGilead Sciences Ltd

Gilead Sciences Ltd
Sovaldi
Tablets 400mg
A1 · Amber 1Stability 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
12 August 2015

New Medicines

SovaldiChronic 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

Licensed but not launched
Licensed but not launched
None
Oct 21Company has no current plans to launch in UK as do not perceive a clinical need [4].
Aug 20Licence extension and new formulation approved in the EU [3].
Apr 20EU 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

Evidence based evaluations