PREVIFEM (21DAY) TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

NORGESTIMATE; ETHINYL ESTRADIOL

Saatavilla:

NOVOPHARM LIMITED

ATC-koodi:

G03AA11

INN (Kansainvälinen yleisnimi):

NORGESTIMATE AND ESTROGEN

Annos:

0.25MG; 0.035MG

Lääkemuoto:

TABLET

Koostumus:

NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG

Antoreitti:

ORAL

Kpl paketissa:

21

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CONTRACEPTIVES

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2018-07-24

Valmisteyhteenveto

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
..................................................................................