ESTRAGYN VAGINAL CREAM

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ESTRONE

Tilgjengelig fra:

SEARCHLIGHT PHARMA INC

ATC-kode:

G03CA07

INN (International Name):

ESTRONE

Dosering :

0.1%

Legemiddelform:

CREAM

Sammensetning:

ESTRONE 0.1%

Administreringsrute:

VAGINAL

Enheter i pakken:

20G/45G

Resept typen:

Prescription

Terapeutisk område:

ESTROGENS

Produkt oppsummering:

Active ingredient group (AIG) number: 0106441002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2015-06-01

Preparatomtale

1
PRODUCT MONOGRAPH
PR
ESTRAGYN
® VAGINAL CREAM
ESTRONE VAGINAL CREAM
CONTAINING ESTRONE 0.1% W/W
ESTROGEN
SEARCHLIGHT PHARMA INC.
DATE OF REVISION:
1600 Notre Dame St. West., Suite 312
August 17, 2016
Montréal, Québec
H3J 1M1
Control # 195579
2
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
.............................................................................................
13
DOSAGE
AND
ADMINISTRATION
.........................................................................
16
OVERDOSAGE
...........................................................................................................
17
ACTION
AND
CLINICAL
PHARMACOLOGY ........................................................
18
STORAGE
AND
STABILITY
.....................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ......................................... 20
PART II: SCIENTIFIC INFORMATION
................................................................... 21
PHARMACEUTICAL
INFORMATION
.....................................................................
21
PIVOTAL
CLINICAL
TRIALS
...................................................................................
21
DETAILED
PHARMACOLOGY
................................................................................
22
TOXICOLOGY
..............................................................................................