VAGIFEM VAGINAL TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ESTRADIOL

Saadav alates:

NOVO NORDISK CANADA INC

ATC kood:

G03CA03

INN (Rahvusvaheline Nimetus):

ESTRADIOL

Annus:

25MCG

Ravimvorm:

VAGINAL TABLET

Koostis:

ESTRADIOL 25MCG

Manustamisviis:

VAGINAL

Ühikuid pakis:

15 TABLETS WITH APPLICATORS

Retsepti tüüp:

Prescription

Terapeutiline ala:

ESTROGENS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2014-07-28

Toote omadused

_ _
_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...................................................................................