MARFEM 28 TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DESOGESTREL; ETHINYL ESTRADIOL

Disponible depuis:

NOVOPHARM LIMITED

Code ATC:

G03AA09

DCI (Dénomination commune internationale):

DESOGESTREL AND ESTROGEN

Dosage:

0.15MG; 0.03MG

forme pharmaceutique:

TABLET

Composition:

DESOGESTREL 0.15MG; ETHINYL ESTRADIOL 0.03MG

Mode d'administration:

ORAL

Unités en paquet:

28

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CONTRACEPTIVES

Descriptif du produit:

Active ingredient group (AIG) number: 0224591001; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2015-10-16

Résumé des caractéristiques du produit

1
PRODUCT MONOGRAPH
PR
MARFEM
21
PR
MARFEM
28
desogestrel and ethinyl estradiol tablets, Novopharm Standard, 0.150
mg/0.030 mg
Oral Contraceptive
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 118484
Date of Preparation:
July 6, 2009
Date of Revision:
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
.................................................................................................
15
DOSAGE AND
ADMINISTRATION.............................................................................
20
OVERDOSAGE
...............................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 23
STORAGE AND
STABILITY.........................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
......................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 26
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL
INFORMATION.........................................................................
27
PART II: SCIENTIFIC INFORMATION
..............................................................................
28
P