País: Canadá
Língua: inglês
Origem: Health Canada
CONJUGATED ESTROGENS
VALEANT CANADA LP / VALEANT CANADA S.E.C.
G03CA57
CONJUGATED ESTROGENS
1.25MG
TABLET
CONJUGATED ESTROGENS 1.25MG
ORAL
100
Prescription
ESTROGENS
Active ingredient group (AIG) number: 0106442003; AHFS:
CANCELLED POST MARKET
2014-07-30
_ _ _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........ Leia o documento completo