OESCLIM PATCH

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ESTRADIOL

Commercializzato da:

SEARCHLIGHT PHARMA INC

Codice ATC:

G03CA03

INN (Nome Internazionale):

ESTRADIOL

Dosaggio:

50MCG

Forma farmaceutica:

PATCH

Composizione:

ESTRADIOL 50MCG

Via di somministrazione:

TRANSDERMAL

Confezione:

8

Tipo di ricetta:

Prescription

Area terapeutica:

ESTROGENS

Dettagli prodotto:

Active ingredient group (AIG) number: 0106457035; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2001-04-04

Scheda tecnica

_ _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OESCLIM
®
Estradiol-17β transdermal system
25 mcg / 24 hrs
37.5 mcg / 24 hrs
50 mcg / 24 hrs
75 mcg / 24 hrs
100 mcg / 24 hrs
Estrogen
Searchlight Pharma Inc.
1600 Notre Dame St. West, Suite 312
Montréal, Québec
H3J 1M1
Date of Preparation:
April 28, 2015
Date of Revision:
February 23, 2017
Submission Control No: 199389
_ _
_ _
_Page 2 of 42_
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
..........................................................