Atorvastatin Alkaloid tablets film-coated

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

atorvastatin (atorvastatin calcium trihydrate)

Pieejams no:

Alkaloid AD Skopje

ATĶ kods:

C10AA05

SNN (starptautisko nepatentēto nosaukumu):

atorvastatin (atorvastatin calcium trihydrate)

Deva:

20mg

Zāļu forma:

tablets film-coated

Vienības iepakojumā:

(30/3x10/) in blister

Receptes veids:

Prescription

Autorizācija statuss:

Registered

Autorizācija datums:

2022-02-03

Produkta apraksts

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