Land: Canada
Sprog: engelsk
Kilde: Health Canada
DESOGESTREL; ETHINYL ESTRADIOL
TEVA CANADA LIMITED
G03AA09
DESOGESTREL AND ESTROGEN
0.15MG; 0.03MG
TABLET
DESOGESTREL 0.15MG; ETHINYL ESTRADIOL 0.03MG
ORAL
28
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0224591001; AHFS:
APPROVED
2015-05-27
_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 ........................... Læs hele dokumentet