Land: Kanada
Språk: engelska
Källa: Health Canada
DESOGESTREL; ETHINYL ESTRADIOL
ORGANON CANADA INC.
G03AA09
DESOGESTREL AND ESTROGEN
0.15MG; 0.03MG
TABLET
DESOGESTREL 0.15MG; ETHINYL ESTRADIOL 0.03MG
ORAL
21
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0224591001; AHFS:
APPROVED
2009-10-01
_MARVELON (desogestrel and ethinyl estradiol) _ _Page 1 of 56_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION MARVELON ® 21 AND MARVELON ® 28 Desogestrel and Ethinyl estradiol Tablets Tablets 0.15 mg Desogestrel and 0.03 mg Ethinyl estradiol, Oral USP Oral Contraceptive Organon Canada Inc. 16766 Trans-Canada highway Kirkland QC H9H 4M7 Date of Initial Approval: July 13, 1993 Date of Revision: July 07, 2022 Submission Control No: 261227 _ _ _MARVELON (desogestrel and ethinyl estradiol) _ _Page 2 of 56_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATION 07-2022 7 Warnings and Precautions 07-2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .................................................................................... 2 TABLE OF CONTENTS ......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION.............................................................. 4 1 INDICATIONS............................................................................................................. 4 1.1 Pediatrics......................................................................................................... 4 1.2 Geriatrics ......................................................................................................... 4 2 CONTRAINDICATIONS .............................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX..................................................... 5 4 DOSAGE AND ADMINISTRATION ............................................................................. 5 4.1 Dosing Considerations ..................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment.................................................. 5 4.4 Administration .................................................................. Läs hela dokumentet