VOSEVI FILM-COATED TABLETS 400MG100MG100MG

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Sofosbuvir; Velpatasvir; Voxilaprevir

Dostupné z:

GILEAD SCIENCES SINGAPORE PTE. LTD.

ATC kód:

J05AP56

Forma lieku:

TABLET, FILM COATED

Zloženie:

Sofosbuvir 400 mg; Velpatasvir 100 mg; Voxilaprevir 100 mg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

Gilead Sciences Ireland UC

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2019-05-31

Súhrn charakteristických

1
VOSEVI
® (SOFOSBUVIR/VELPATASVIR/VOXILAPREVIR) TABLETS
R
x
Only
1.
NAME OF THE MEDICINAL PRODUCT
Vosevi 400 mg/100 mg/100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir
and 100 mg voxilaprevir.
Excipients with known effect
Each film-coated tablet contains 111 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm,
debossed with “GSI” on one
side and “3” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vosevi is indicated for the treatment of chronic hepatitis C virus
(HCV) infection in adults (see
sections 4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vosevi treatment should be initiated and monitored by a physician
experienced in the management of
patients with HCV infection.
Posology
The recommended dose of Vosevi is one tablet, taken orally, once daily
with food (see section 5.2).
The recommended durations of treatment applicable to all HCV genotypes
are shown in Table 1.
2
TABLE 1: RECOMMENDED TREATMENT DURATIONS FOR VOSEVI
GENOTYPE
PATIENT POPULATION
TREATMENT DURATION
1, 2, 3, 4, 5 or 6
DAA experienced patients* without cirrhosis previously
treated with an HCV regimen containing an NS5A inhibitor
12 weeks
1, 3 or 4
DAA experienced patients* with compensated cirrhosis
previously treated with an HCV regimen containing an
NS5A inhibitor
12 weeks
1, 2, 3 or 4
DAA experienced patients* with compensated cirrhosis or
without cirrhosis previously treated with an HCV regimen
containing sofosbuvir without an NS5A inhibitor
12 weeks
3
DAA naïve patients with compensated cirrhosis
8 weeks (see section 5.1)
DAA: direct-acting antiviral agent
* In clinical trials the DAA experienced patients had been exposed to
combination regimens containing any of the following:
daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir,
pari