ROZEVON FILM-COATED TABLET 5MG10MG

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Ezetimibe; Rosuvastatin calcium eqv Rosuvastatin

Disponible des:

NOVEM PHARMA PRIVATE LIMITED

Codi ATC:

C10BA06

formulario farmacéutico:

TABLET, FILM COATED

Composición:

Ezetimibe 10.0 mg; Rosuvastatin calcium eqv Rosuvastatin 5.0 mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricat per:

ELPEN Pharmaceutical Co Inc

Estat d'Autorització:

ACTIVE

Data d'autorització:

2022-07-04

Fitxa tècnica

ROZEVON
(ROSUVASTATIN + EZETIMIBE)
1
NAME OF THE MEDICINAL PRODUCT
ROZEVON FILM-COATED TABLET 5MG/10MG
ROZEVON FILM-COATED TABLET 10MG/10MG
ROZEVON FILM-COATED TABLET 20MG/10MG
ROZEVON FILM-COATED TABLET 40MG/10MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ROZEVON FILM-COATED TABLET 5MG/10MG
Each film-coated tablet contains 5.20 mg rosuvastatin calcium
(equivalent to 5 mg
rosuvastatin) and 10 mg of ezetimibe.
ROZEVON FILM-COATED TABLET 10MG/10MG
Each film-coated tablet contains 10.40 mg rosuvastatin calcium
(equivalent to 10 mg
rosuvastatin) and 10 mg of ezetimibe.
ROZEVON FILM-COATED TABLET 20MG/10MG
Each film-coated tablet contains 20.80 mg rosuvastatin calcium
(equivalent to 20 mg
rosuvastatin) and 10 mg of ezetimibe.
ROZEVON FILM-COATED TABLET 40MG/10MG
Each film-coated tablet contains 41.60 mg rosuvastatin calcium
(equivalent to 40 mg
rosuvastatin) and 10 mg of ezetimibe.
Excipients with known effect:
ROZEVON FILM-COATED TABLET 5MG/10MG: Each film-coated tablet contains
200.50 mg of
lactose monohydrate.
ROZEVON FILM-COATED TABLET 10MG/10MG: Each film-coated tablet contains
200.50 mg
of lactose monohydrate.
ROZEVON FILM-COATED TABLET 20MG/10MG: Each film-coated tablet contains
200.50 mg
of lactose monohydrate.
ROZEVON FILM-COATED TABLET 40MG/10MG: Each film-coated tablet contains
200.50 mg
of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablets
5 mg / 10 mg: Light yellow, round, biconvex film coated tablets with a
diameter of 10mm
approximately and "EL 5" embossed on one side
10 mg / 10 mg: Beige, round, biconvex film coated tablets with a
diameter of 10mm
approximately and "EL 4" embossed on one side
20 mg / 10 mg: Yellow, round, biconvex film coated tablets with a
diameter of 10mm
approximately and "EL 3" embossed on one side
40 mg / 10 mg: White, round, biconvex film coated tablets with a
diameter of 10mm
approximately and "EL 2" embossed on one side
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ROZEVON is indicated as adjunct to diet for