C.E.S. TABLETS

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CONJUGATED ESTROGENS

Tersedia dari:

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

Kode ATC:

G03CA57

INN (Nama Internasional):

CONJUGATED ESTROGENS

Dosis:

0.3MG

Bentuk farmasi:

TABLET

Komposisi:

CONJUGATED ESTROGENS 0.3MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

ESTROGENS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2014-07-30

Karakteristik produk

_ _
_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........