Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL
PATRIOT A DIVISION OF JANSSEN INC
G03AB11
NORGESTIMATE AND ESTROGEN
0.180MG; 0.035MG; 0.215MG; 0.035MG; 0.250MG; 0.035MG
TABLET
NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.035MG
ORAL
28
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0636783002; AHFS:
CANCELLED PRE MARKET
2017-08-03
_165350.doc _ _ _ _Page 1 of 51 _ PRODUCT MONOGRAPH PR CENTRISA ™ 21 AND PR CENTRISA ™ 28 norgestimate and ethinyl estradiol tablets, House Std. 0.180 mg norgestimate and 0.035 mg ethinyl estradiol Tablets 0.215 mg norgestimate and 0.035 mg ethinyl estradiol Tablets 0.250 mg norgestimate and 0.035 mg ethinyl estradiol Tablets Oral Contraceptive Patriot, a Division of Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.patriot-canada.ca Date of Preparation: August 19, 2013 SUBMISSION CONTROL NO.: 165350 All trademarks used under license. © 2013 Patriot, a Division of Janssen Inc. _165350.doc _ _ _ _Page 2 of 51 _ PRODUCT MONOGRAPH PR CENTRISA ™ 21 AND PR CENTRISA ™ 28 norgestimate and ethinyl estradiol tablets, House Std. 0.180 mg norgestimate and 0.035 mg ethinyl estradiol Tablets 0.215 mg norgestimate and 0.035 mg ethinyl estradiol Tablets 0.250 mg norgestimate and 0.035 mg ethinyl estradiol Tablets PHARMACOLOGICAL CLASSIFICATION Synthetic steroidal combination oral contraceptive. CLINICAL PHARMACOLOGY The primary mechanism of action of CENTRISA ™ Tablets is an inhibition of ovulation. Additionally, other effects caused by the treatment (for example, alteration of the endometrium and the thickening of the cervical mucus) appear to interfere with implantation and conception. INDICATIONS AND CLINICAL USE CENTRISA ™ Tablets are indicated for conception control. CENTRISA ™ Tablets are indicated for the treatment of moderate acne vulgaris in females who have no known contraindications to oral contraceptive therapy. CONTRAINDICATIONS 1. History of or actual thrombophlebitis or thromboembolic disorders. 2. Known thrombophilic conditions. 3. History of or actual cerebrovascular disorders. 4. History of or actual myocardial infarction or coronary arterial disease. 5. Active liver disease or history of or actual benign or malignant liver tumours. 6. Known or suspected carcinoma of the breast. 7. Known or suspected estrogen-dependent neoplasia. 8. Undiagnosed abnormal vaginal bleeding. 9. Any ocula Կարդացեք ամբողջական փաստաթուղթը