TRI-PREVIFEM (28 DAY) TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL

Disponible depuis:

NOVOPHARM LIMITED

Code ATC:

G03AB

DCI (Dénomination commune internationale):

PROGESTOGENS AND ESTROGENS, SEQUENTIAL PREPARATIONS

Dosage:

0.180MG; 0.035MG; 0.215MG; 0.035MG; 0.250MG; 0.035MG

forme pharmaceutique:

TABLET

Composition:

NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.035MG

Mode d'administration:

ORAL

Unités en paquet:

28

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CONTRACEPTIVES

Descriptif du produit:

Active ingredient group (AIG) number: 0636783002; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2018-07-24

Résumé des caractéristiques du produit

_Page 1_
PRODUCT MONOGRAPH
PR
TRI-PREVIFEM
0.180 mg norgestimate and 0.035 mg ethinyl estradiol
0.215 mg norgestimate and 0.035 mg ethinyl estradiol
0.250 mg norgestimate and 0.035 mg ethinyl estradiol
Tablets
Novopharm Standard
Oral Contraceptive
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 116255
Date of Preparation:
January 31, 2005
Date of revision:
December 2, 2008
_Page 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...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND
ADMINISTRATION.............................................................................
17
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND
STABILITY.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.............................................................