Table of Contents
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
-------------------------------------------
1. Name of the medicinal product
 Sovaldi 400 mg film-coated tablets
2. Qualitative and quantitative composition
 Each film-coated tablet contains 400 mg of sofosbuvir.

For the full list of excipients, see section 6.1.
3. Pharmaceutical form
 Film-coated tablet.

Yellow, capsule-shaped, film-coated tablet of dimensions 20 mm x 9 mm, debossed on one side with “GSI” and “7977” on the other side.
4. Clinical particulars
  
4.1 Therapeutic indications
 Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).

For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
4.2 Posology and method of administration
 Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.

Posology

The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2).

Sovaldi should be used in combination with other medicinal products. Monotherapy of Sovaldi is not recommended (see section 5.1). Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with Sovaldi. The recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy are provided in Table 1.

Table 1: Recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy

Patient population*
 Treatment
 Duration
 
Patients with genotype 1, 4, 5 or 6 CHC
 Sovaldi + ribavirin + peginterferon alfa
 12 weeksa, b
 
Sovaldi + ribavirin

Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
 24 weeks
 
Patients with genotype 2 CHC
 Sovaldi + ribavirin
 12 weeksb
 
Patients with genotype 3 CHC
 Sovaldi + ribavirin + peginterferon alfa
 12 weeksb
 
Sovaldi + ribavirin
 24 weeks
 
Patients with CHC awaiting liver transplantation
 Sovaldi + ribavirin
 Until liver transplantationc
 
* Includes