ESTROGEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESTRADIOL (ESTRADIOL HEMIHYDRATE)

Available from:

ORGANON CANADA INC.

ATC code:

G03CA03

INN (International Name):

ESTRADIOL

Dosage:

0.06%

Pharmaceutical form:

GEL

Composition:

ESTRADIOL (ESTRADIOL HEMIHYDRATE) 0.06%

Administration route:

TRANSDERMAL

Units in package:

80G

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0106457004; AHFS:

Authorization status:

APPROVED

Authorization date:

1998-09-15

Summary of Product characteristics

_ESTROGEL (17β-estradiol, as estradiol hemihydrate) _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ESTROGEL
®
17β-estradiol, as estradiol hemihydrate
Transdermal gel, 0.06% w/w
Estrogen
Organon Canada Inc.
16766 Trans-Canada highway
Kirkland QC H9H 4M7
Date of Initial Approval:
September 15, 1998
Date of Revision:
MAR 06, 2024
Submission Control No: 280464
_ _
_ESTROGEL (17β-estradiol, as estradiol hemihydrate) _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.1 Dosing considerations
08/2023
7 Warnings and Precautions
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
........................................................................................2
TABLE OF CONTENTS
..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................4
1
INDICATIONS
..................................................................................................................4
1.1
Pediatrics
..............................................................................................................4
1.2
Geriatrics
..............................................................................................................4
2
CONTRAINDICATIONS
..................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................4
4
DOSAGE AND ADMINISTRATION
.................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage Adjustment
....................................................6
4.4
Administration
.................................................