C.E.S. TABLETS

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

CONJUGATED ESTROGENS

Disponibbli minn:

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

Kodiċi ATC:

G03CA57

INN (Isem Internazzjonali):

CONJUGATED ESTROGENS

Dożaġġ:

0.3MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

CONJUGATED ESTROGENS 0.3MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ESTROGENS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2014-07-30

Karatteristiċi tal-prodott

_ _
_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........