VAGIFEM VAGINAL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESTRADIOL

Available from:

NOVO NORDISK CANADA INC

ATC code:

G03CA03

INN (International Name):

ESTRADIOL

Dosage:

25MCG

Pharmaceutical form:

VAGINAL TABLET

Composition:

ESTRADIOL 25MCG

Administration route:

VAGINAL

Units in package:

15 TABLETS WITH APPLICATORS

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0106457005; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-07-28

Summary of Product characteristics

_ _
_Vagifem_
_®_
_ (estradiol vaginal tablet) _
_Page 1 of 33_
PRODUCT MONOGRAPH
_PR_
VAGIFEM
®
17SS-ESTRADIOL
VAGINAL TABLET WITH APPLICATOR, 25 ΜG
ESTROGEN
Manufacturer’s Standard
Hormone Therapy
_NOVO NORDISK CANADA INC. _
300 – 2680 Skymark Ave.
Mississauga, Ontario
L4W 5L6
DATE OF REVISION:
12 July 2011
SUBMISSION CONTROL NO: 141555
_ _
_Vagifem_
_®_
_ (estradiol vaginal tablet) _
_Page 2 of 33_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND
ADMINISTRATION..............................................................................16
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND
STABILITY..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL
INFORMATION..........................................................................22
CLINICAL
TRIALS...................................................................................