VAGIFEM VAGINAL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ESTRADIOL

제공처:

NOVO NORDISK CANADA INC

ATC 코드:

G03CA03

INN (국제 이름):

ESTRADIOL

복용량:

25MCG

약제 형태:

VAGINAL TABLET

구성:

ESTRADIOL 25MCG

관리 경로:

VAGINAL

패키지 단위:

15 TABLETS WITH APPLICATORS

처방전 유형:

Prescription

치료 영역:

ESTROGENS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2014-07-28

제품 특성 요약

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