LUPIN-ESTRADIOL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESTRADIOL (ESTRADIOL HEMIHYDRATE)

Available from:

LUPIN PHARMA CANADA LIMITED

ATC code:

G03CA03

INN (International Name):

ESTRADIOL

Dosage:

1MG

Pharmaceutical form:

TABLET

Composition:

ESTRADIOL (ESTRADIOL HEMIHYDRATE) 1MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0106457003; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-11-16

Summary of Product characteristics

_LUPIN-ESTRADIOL (17β-estradiol) _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUPIN-ESTRADIOL
17β-estradiol Tablets, USP
Tablets, 0.5 mg, 1 mg, 2 mg 17β-estradiol (as Estradiol Hemihydrate),
Oral
USP
Estrogen
Lupin Pharma Canada Limited
1111, rue St-Charles
Ouest Suite
550,Longueuil, Québec,
Canada
J4K 5G4
Date of Initial Authorization:
NOV 13, 2015
Date of Revision:
Sep 22, 2022
Submission Control Number: 263260
Page 2 of 32
_LUPIN-ESTRADIOL (17β-estradiol) _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1. Pediatrics, 1.2 Geriatrics
09/2022
2 CONTRAINDICATIONS
09/2022
3 SERIOUS WARNINGS AND PRECAUTIONS, Serious Warnings and Precautions
Box
09/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
09/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
09/2022
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
09/2022
7 WARNINGS AND PRECAUTIONS, General
09/2022
7 WARNINGS AND PRECAUTIONS, Hyperlipoproteinemia / Hyperglycemia
09/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
09/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
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TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................................
4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics.............................................................................................................
4
1.2
Geriatrics..............................................................................................................
4
2
CONTRAINDICATIONS....................................................................................................