Atorvastatin Alkaloid tablets film-coated

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

atorvastatin (atorvastatin calcium trihydrate)

זמין מ:

Alkaloid AD Skopje

קוד ATC:

C10AA05

INN (שם בינלאומי):

atorvastatin (atorvastatin calcium trihydrate)

כמות:

80mg

טופס פרצבטיות:

tablets film-coated

יחידות באריזה:

(30/3x10/) in blister

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2022-02-03

מאפייני מוצר

Atorvastatin Alkaloid 10 mg; 20 mg; 40 mg & 80 mg film-coated tablets
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atorvastatin Alkaloid 10 mg film-coated tablets
Atorvastatin Alkaloid 20 mg film-coated tablets
Atorvastatin Alkaloid 40 mg film-coated tablets
Atorvastatin Alkaloid 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atorvastatin Alkaloid 10 mg film-coated tablets
One film-coated tablet contains 10 mg of atorvastatin (as atorvastatin
calcium trihydrate).
Atorvastatin Alkaloid 20 mg film-coated tablets
One film-coated tablet contains 20 mg of atorvastatin (as atorvastatin
calcium trihydrate).
Atorvastatin Alkaloid 40 mg film-coated tablets
One film-coated tablet contains 40 mg of atorvastatin (as atorvastatin
calcium trihydrate).
Atorvastatin Alkaloid 80 mg film-coated tablets
One film-coated tablet contains 80 mg of atorvastatin (as atorvastatin
calcium trihydrate).
Excipients with known effect:
One Atorvastatin Alkaloid 10 mg film-coated tablet contains 45.82 mg
lactose.
One Atorvastatin Alkaloid 20 mg film-coated tablet contains 91.63 mg
lactose.
One Atorvastatin Alkaloid 40 mg film-coated tablet contains 183.26 mg
lactose.
One Atorvastatin Alkaloid 80 mg film-coated tablet contains 366.53 mg
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Atorvastatin Alkaloid 10 mg film-coated tablets
White, round, biconvex film-coated tablets with bisection line on one
side and debossing 10 on other side.
The dimensions of each tablet are approximately 7.0 mm. The tablet can
be divided into equal doses.
Atorvastatin Alkaloid 20 mg film-coated tablets
White, round, biconvex film-coated tablets with bisection line on one
side and debossing 20 on other side.
The dimensions of each tablet are approximately 9.0 mm. The tablet can
be divided into equal doses.
Atorvastatin Alkaloid 40 mg film-coated tablets
White, round, biconvex film-coated tablets with bisection line on one
side and deboss