C.E.S. TABLETS

国: カナダ

言語: 英語

ソース: Health Canada

即購入

ダウンロード 製品の特徴 (SPC)
09-06-2009

有効成分:

CONJUGATED ESTROGENS

から入手可能:

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

ATCコード:

G03CA57

INN(国際名):

CONJUGATED ESTROGENS

投薬量:

0.3MG

医薬品形態:

TABLET

構図:

CONJUGATED ESTROGENS 0.3MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

ESTROGENS

製品概要:

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

認証ステータス:

CANCELLED POST MARKET

承認日:

2014-07-30

製品の特徴

                                _ _
_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........
                                
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