C.E.S. TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-09-2020
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Active ingredient:
CONJUGATED ESTROGENS
Available from:
BAUSCH HEALTH, CANADA 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:
100/1000
Prescription type:
Prescription
Therapeutic area:
ESTROGENS
Product summary:
Active ingredient group (AIG) number: 0106442006; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-09-23
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
C.E.S.
Conjugated Estrogens Tablets, CSD
0.625 mg
ESTROGEN
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
September 23, 2020
Laval, Quebec
H7L 4A8
Control No.: 242944
_Pr_
_C.E.S._
_®_
_ Product Monograph Page 2 of 33_
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................20
SPECIAL HANDLING INSTRUCTIONS
.......................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................24
DETAIL
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