VAGIFEM 10 VAGINAL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESTRADIOL (ESTRADIOL HEMIHYDRATE)

Available from:

NOVO NORDISK CANADA INC

ATC code:

G03CA03

INN (International Name):

ESTRADIOL

Dosage:

10MCG

Pharmaceutical form:

VAGINAL TABLET

Composition:

ESTRADIOL (ESTRADIOL HEMIHYDRATE) 10MCG

Administration route:

VAGINAL

Units in package:

18

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0106457031; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-09-13

Summary of Product characteristics

_ _
_Page 1 of 34 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VAGIFEM
® 10
Estradiol vaginal inserts USP, 10 mcg estradiol
Vaginal inserts with applicators
Estrogen
Novo Nordisk Canada Inc.
101-2476 Argentia Road
Mississauga, Ontario
L5N 6M1
Date of Initial Authorization:
23 April 2009
Date of Revision:
November 01, 2023
Submission Control Number: 276051
_Vagifem® 10 (estradiol vaginal insert USP) _
_Page 2 of 34 _
TABLE OF CONTENTS
TABLE OF CONTENTS .....................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 4
1
INDICATIONS ..........................................................................................................
4
1.1
Pediatrics
...........................................................................................................
4
2
CONTRAINDICATIONS ..........................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................. 5
4
DOSAGE AND ADMINISTRATION ........................................................................
5
4.1
Dosing Considerations
....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................... 5
4.4
Administration
...................................................................................................
5
4.5
Missed Dose
.....................................................................................................
6
5
OVERDOSAGE ........................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. 6
7
WARNINGS AND PRECAUTIONS .........................................................................
6
7.1
Special Populations
..........................................................