PMS-CONJUGATED ESTROGENS C.S.D. TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CONJUGATED ESTROGENS

Available from:

PHARMASCIENCE INC

ATC code:

G03CA57

INN (International Name):

CONJUGATED ESTROGENS

Dosage:

0.625MG

Pharmaceutical form:

TABLET

Composition:

CONJUGATED ESTROGENS 0.625MG

Administration route:

ORAL

Units in package:

500

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0106442006; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-09-30

Summary of Product characteristics

_pms-Conjugated Estrogens CSD (tablets) _
_ _
_ _
_ _
_ page 1 of 42 _
_ _
PRODUCT MONOGRAPH
PR
PMS-CONJUGATED ESTROGENS CSD
(conjugated estrogens tablets, CSD)
0.3 mg, 0.625 mg, 0.9 mg, and 1.25 mg
ESTROGENIC HORMONES
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
AUGUST 28, 2009
Montreal, Quebec
H4P 2T4
CONTROL NUMBER: 120633
_pms-Conjugated Estrogens CSD (tablets) _
_ _
_ _
_ _
_ page 2 of 42 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION……………………………...
3
SUMMARY PRODUCT
INFORMATION……………………………………….3
INDICATIONS AND CLINICAL
USE…………………………………………...3
CONTRAINDICATIONS…………………………………………………………4
WARNINGS AND
PRECAUTIONS…………………………………….……….5
ADVERSE
REACTIONS………………………………………………………...13
DRUG
INTERACTIONS………………………………………………………...18
DOSAGE AND
ADMINISTRATION…………………………………………...20
OVERDOSAGE………………………………………………………………….22
ACTION AND CLINICAL
PHARMACOLOGY……………………………….23
STORAGE AND
STABILITY…………………………………………………...26
SPECIAL HANDLING
INSTRUCTIONS………………………………………26
DOSAGE FORMS, COMPOSITION AND PACKAGING……………………..26
PART II: SCIENTIFIC
INFORMATION…………………………………………….
27
PHARMACEUTICAL
INFORMATION………………………………………...27
CLINICAL
TRIALS……………………………………………………………...27
DETAILED
PHARMACOLOGY………………………………………………..32
REFERENCES…………………………………………………………………...33
PART III: CONSUMER
INFORMATION……………………………………………………
37
_pms-Conjugated Estrogens CSD (tablets) _
_ _
_