JAMP ATORVASTATIN TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-08-2020
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Active ingredient:
ATORVASTATIN (ATORVASTATIN CALCIUM)
Available from:
JAMP PHARMA CORPORATION
ATC code:
C10AA05
INN (International Name):
ATORVASTATIN
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0133055003; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-08-12
Summary of Product characteristics
Page 1 of 56
PRODUCT MONOGRAPH
PR
JAMP ATORVASTATIN TABLETS
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG ATORVASTATIN
LIPID METABOLISM REGULATOR
JAMP PHARMA CORPORATION
DATE OF PREPARATION:
1310, RUE NOBEL
AUGUST 10, 2020
BOUCHERVILLE, QUÉBEC
J4B 5H3
CONTROL # 240265
Page 2 of 56
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
.......................................................................................................................
11
DRUG INTERACTIONS
.......................................................................................................................
14
DOSAGE AND ADMINISTRATION
...................................................................................................
22
OVERDOSAGE
.....................................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
23
STORAGE AND STABILITY
...............................................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
............................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................. 27
PART II: SCIENTIFIC INFORMATION
..
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