C.E.S. TABLETS

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CONJUGATED ESTROGENS

Beschikbaar vanaf:

VALEANT CANADA LP / VALEANT CANADA S.E.C.

ATC-code:

G03CA57

INN (Algemene Internationale Benaming):

CONJUGATED ESTROGENS

Dosering:

0.3MG

farmaceutische vorm:

TABLET

Samenstelling:

CONJUGATED ESTROGENS 0.3MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

ESTROGENS

Product samenvatting:

Active ingredient group (AIG) number: 0106442002; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2014-07-30

Productkenmerken

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_C.E.S.® (conjugated estrogens tablets, CSD) _
_Page 1 of 32_
PRODUCT MONOGRAPH
Pr
C.E.S.
®
(conjugated estrogens tablets, CSD)
0.3 mg, 0.625 mg, 0.9 mg, and 1.25 mg
Estrogen
Valeant Canada limitée/Limited
4787 Levy Street
Montreal, Quebec
H4R 2P9
DATE OF REVISION:
JUNE 03, 2009
SUBMISSION CONTROL NO: 121115
_ _
_C.E.S.® (conjugated estrogens tablets, CSD) _
_Page 2 of 32_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND
ADMINISTRATION..............................................................................16
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND
STABILITY..........................................................................................20
SPECIAL HANDLING INSTRUCTIONS
.......................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL
INFORMATION..........................................................................22
CLINICAL
TRIALS........