PROVERA 5MG TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-10-2014
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Active ingredient:
MEDROXYPROGESTERONE ACETATE
Available from:
PFIZER CANADA ULC
ATC code:
G03DA02
INN (International Name):
MEDROXYPROGESTERONE
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
MEDROXYPROGESTERONE ACETATE 5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PROGESTINS
Product summary:
Active ingredient group (AIG) number: 0106339005; AHFS:
Authorization status:
APPROVED
Authorization date:
1998-03-05
Summary of Product characteristics
_ _
_PROVERA (medroxyprogesterone acetate) Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
PROVERA*
(medroxyprogesterone acetate tablets USP)
2.5 mg, 5 mg and 10 mg tablets
PROGESTIN
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
29 September 2014
SUBMISSION CONTROL NO: 176877
* TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2014
_ _
_PROVERA (medroxyprogesterone acetate) Product Monograph _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
...........................................................................................
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