VAGIFEM VAGINAL TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ESTRADIOL

Mevcut itibaren:

NOVO NORDISK CANADA INC

ATC kodu:

G03CA03

INN (International Adı):

ESTRADIOL

Doz:

25MCG

Farmasötik formu:

VAGINAL TABLET

Kompozisyon:

ESTRADIOL 25MCG

Uygulama yolu:

VAGINAL

Paketteki üniteler:

15 TABLETS WITH APPLICATORS

Reçete türü:

Prescription

Terapötik alanı:

ESTROGENS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2014-07-28

Ürün özellikleri

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