DOM-ATORVASTATIN TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Saadav alates:

DOMINION PHARMACAL

ATC kood:

C10AA05

INN (Rahvusvaheline Nimetus):

ATORVASTATIN

Annus:

10MG

Ravimvorm:

TABLET

Koostis:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

500

Retsepti tüüp:

Prescription

Terapeutiline ala:

HMG-COA REDUCTASE INHIBITORS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0133055001; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2019-07-31

Toote omadused

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PRODUCT MONOGRAPH
PR
DOM-ATORVASTATIN
(Atorvastatin calcium tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
DOMINION PHARMACAL
Date of Revision: July 26, 2016
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Submission Control No: 196412
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
....................................................................................
18
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 19
STORAGE AND STABILITY
................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
...................