APRI 28 TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

DESOGESTREL; ETHINYL ESTRADIOL

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

G03AA09

INN (Algemene Internationale Benaming):

DESOGESTREL AND ESTROGEN

Dosering:

0.15MG; 0.03MG

farmaceutische vorm:

TABLET

Samenstelling:

DESOGESTREL 0.15MG; ETHINYL ESTRADIOL 0.03MG

Toedieningsweg:

ORAL

Eenheden in pakket:

28

Prescription-type:

Prescription

Therapeutisch gebied:

CONTRACEPTIVES

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2015-05-27

Productkenmerken

_Page 1 _
PRODUCT MONOGRAPH
PR
APRI
®
21 AND
PR
APRI
®
28
0.15 mg desogestrel and 0.03 mg ethinyl estradiol tablets,
USP
Oral Contraceptive
Teva Canada Limited
Date of Revision:
30 Novopharm Court
November 27, 2020
Toronto, ON M1B 2K9
Submission Control No: 240987
_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
......................................................................................................
12
DRUG INTERACTIONS
......................................................................................................
17
DOSAGE AND ADMINISTRATION
..................................................................................
25
OVERDOSAGE
.....................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 28
STORAGE AND STABILITY
..............................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
............................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 31
PART II: SCIENTIFIC INFORMATION
....................................................................................
32
PHARMACEUTICAL INFORMATION
..............................................................................
32
CLINICAL TRIALS
...........................