ESTRACOMB PATCH

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ESTRADIOL; NORETHINDRONE ACETATE; ESTRADIOL

Διαθέσιμο από:

NOVARTIS PHARMACEUTICALS CANADA INC

Φαρμακολογική κατηγορία (ATC):

G03FB05

INN (Διεθνής Όνομα):

NORETHISTERONE AND ESTROGEN

Δοσολογία:

4MG; 30MG; 10MG

Φαρμακοτεχνική μορφή:

PATCH

Σύνθεση:

ESTRADIOL 4MG; NORETHINDRONE ACETATE 30MG; ESTRADIOL 10MG

Οδός χορήγησης:

TRANSDERMAL

Μονάδες σε πακέτο:

8

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ESTROGENS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0336586001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2009-06-08

Αρχείο Π.Χ.Π.

_ _
_ESTRACOMB* _
_Page 1 of 47_
PRODUCT MONOGRAPH
Pr
ESTRACOMB*
Pr
ESTRADERM* +
Pr
ESTRAGEST*
(Estradiol-17ß + Norethindrone Acetate and Estradiol-17ß)
Transdermal Therapeutic System
Progestin-Estrogen
NOVARTIS PHARMACEUTICALS CANADA INC.
Dorval, Québec, H9S 1A9
SUBMISSION CONTROL NUMBER 120563
Date of Revision:
February 05, 2009
* registered trademark
_ _
_ESTRACOMB* _
_Page 2 of 47_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS..................................................................................................12
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND
ADMINISTRATION..............................................................................18
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
STORAGE AND
STABILITY..........................................................................................27
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL
INFORMATION..........................................................................30
CLINICAL
TRIALS..........................................................................................................31
DETAILED
PHARMACOLOGY.............................................................................