PAL-PRAVASTATIN-ASA TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-09-2012
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Active ingredient:
PRAVASTATIN SODIUM; ACETYLSALICYLIC ACID
Available from:
PALADIN LABS INC.
ATC code:
C10BX02
INN (International Name):
PRAVASTATIN AND ACETYLSALICYLIC ACID
Dosage:
40MG; 81MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
PRAVASTATIN SODIUM 40MG; ACETYLSALICYLIC ACID 81MG
Administration route:
ORAL
Units in package:
10+10
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0251548003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2015-07-31
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR PAL-PRAVASTATIN-ASA
Acetylsalicylic acid delayed-release tablets/caplets USP
81 mg,162 mg and 325 mg
and
Pravastatin sodium tablets
10 mg, 20 mg and 40 mg
PLATELET AGGREGATION INHIBITOR
AND
LIPID METABOLISM REGULATOR
Paladin Labs Inc.
Date of Revision:
6111 Royalmount Ave. Suite #102
September 19, 2012
Montreal, Quebec
H4P 2T4
Control No. 158368
_ _
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
4
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................
5
ADVERSE REACTIONS
..........................................................................................................
12
DRUG INTERACTIONS
..........................................................................................................
17
DOSAGE AND ADMINISTRATION
......................................................................................
19
OVERDOSAGE
........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
..................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
..................................................................................
26
CLINICAL TRIALS
.
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