PREVIFEM (21DAY) TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

NORGESTIMATE; ETHINYL ESTRADIOL

Disponible des:

NOVOPHARM LIMITED

Codi ATC:

G03AA11

Designació comuna internacional (DCI):

NORGESTIMATE AND ESTROGEN

Dosis:

0.25MG; 0.035MG

formulario farmacéutico:

TABLET

Composición:

NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG

Vía de administración:

ORAL

Unidades en paquete:

21

tipo de receta:

Prescription

Área terapéutica:

CONTRACEPTIVES

Resumen del producto:

Active ingredient group (AIG) number: 0213627001; AHFS:

Estat d'Autorització:

CANCELLED PRE MARKET

Data d'autorització:

2018-07-24

Fitxa tècnica

PRODUCT MONOGRAPH
PR
PREVIFEM
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: 116290
Date of Preparation:
August 20, 2007
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
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE.................................................................................................................19
ACTION AND CLINICAL
PHARMACOLOGY.............................................................19
STORAGE AND STABILITY
..........................................................................................20
SPECIAL HANDLING
INSTRUCTIONS........................................................................20
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL
INFORMATION..........................................................................22
CLINICAL TRIALS
..................................................................................