HEPCINAT Tablets 400 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Sofosbuvir

Available from:

Natco Pharma Limited, INDIA

INN (International Name):

Sofosbuvir

Dosage:

400 mg

Pharmaceutical form:

Tablets

Manufactured by:

Natco Pharma Limited, INDIA

Product summary:

Physical description: Brick red coloured, capsule shaped, film coated tablets debossed with '400' on one side and plain on other side; Local technical representative: Avacare Tanzania (67333)

Authorization status:

Registered/Compliant

Authorization date:

2019-08-02

Summary of Product characteristics

Summary of Product Characteristics
1. Name of the medicinal product
HEPCINAT 400 mg film-coated tablets
2. Qualitative and quantitative composition
HEPCINAT 400 mg film-coated tablets
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.
HEPCINAT 400 mg film-coated tablets
Brick red coloured, capsule shaped, film coated tablets debossed with ’400’ on one side and plain
on other side.
4. Clinical particulars
4.1 Therapeutic indications
HEPCINAT is indicated in combination with other medicinal products for the treatment of chronic
hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (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
HEPCINAT treatment should be initiated and monitored by a physician experienced in the
management of patients with CHC.
Posology
The recommended dose of HEPCINAT in adults is one 400 mg tablet, taken orally, once daily
with food (see section 5.2).
The recommended dose of HEPCINAT in paediatric patients aged 3 years and above is based
on weight (as detailed in Table 2). HEPCINAT should be taken with food (see section 5.2).
HEPCINAT oral granules are available for the treatment of chronic HCV-infection in paediatric
patients aged 3 years and above having difficulty in swallowing film-coated tablets. Please refer
to the Summary of Product Characteristics for HEPCINAT 150 mg or 200 mg granules.