PROVERA 100MG TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-12-2009
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Active ingredient:
MEDROXYPROGESTERONE ACETATE
Available from:
PFIZER CANADA ULC
ATC code:
G03DA02
INN (International Name):
MEDROXYPROGESTERONE
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
MEDROXYPROGESTERONE ACETATE 100MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PROGESTINS
Product summary:
Active ingredient group (AIG) number: 0106339007; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2012-02-13
Summary of Product characteristics
_ _
_PROVERA / PROVERA-PAK (medroxyprogesterone acetate) Product Monograph
_
_Page 1 of 42_
PRODUCT MONOGRAPH
PR
PROVERA*
(medroxyprogesterone acetate USP)
2.5 mg, 5 mg, 10 mg and 100 mg tablets
and
PR
PROVERA-PAK*
(medroxyprogesterone acetate USP)
5 mg and 10 mg tablets
PROGESTIN
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
DATE OF REVISION:
December 9, 2009
SUBMISSION CONTROL NO: 133050
* TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2009
_PROVERA / PROVERA-PAK (medroxyprogesterone acetate) Product Monograph
_
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS..................................................................................................14
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND
ADMINISTRATION..............................................................................18
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND
STABILITY..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL
INFORMATION..........................................................................27
CLINICAL
TRIAL
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