CENTRISA LO 28 TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ETHINYL ESTRADIOL; NORGESTIMATE; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL

Saatavilla:

PATRIOT A DIVISION OF JANSSEN INC

ATC-koodi:

G03AB11

INN (Kansainvälinen yleisnimi):

NORGESTIMATE AND ESTROGEN

Annos:

0.025MG; 0.180MG; 0.215MG; 0.025MG; 0.250MG; 0.025MG

Lääkemuoto:

TABLET

Koostumus:

ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.180MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.025MG

Antoreitti:

ORAL

Kpl paketissa:

28

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CONTRACEPTIVES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0636783003; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2017-08-03

Valmisteyhteenveto

_165473.doc _
_ _
_Page 1 of 52 _
PRODUCT MONOGRAPH
PR
CENTRISA
™ LO 21 AND
PR
CENTRISA
™ LO 28
norgestimate and ethinyl estradiol Tablets, House Std.
0.180 mg norgestimate and 0.025 mg ethinyl estradiol
0.215 mg norgestimate and 0.025 mg ethinyl estradiol
0.250 mg norgestimate and 0.025 mg ethinyl estradiol
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.:
165473
© 2013 Patriot, a Division of Janssen Inc.
All trademarks used under license.
_165473.doc _
_ _
_Page 2 of 52 _
PRODUCT MONOGRAPH
PR
CENTRISA
™ LO 21 AND
PR
CENTRISA
™ LO 28
norgestimate and ethinyl estradiol Tablets, House Std.
0.180 mg norgestimate and 0.025 mg ethinyl estradiol
0.215 mg norgestimate and 0.025 mg ethinyl estradiol
0.250 mg norgestimate and 0.025 mg ethinyl estradiol
PHARMACOLOGICAL CLASSIFICATION
Synthetic steroidal combination oral contraceptive.
CLINICAL PHARMACOLOGY
ORAL CONTRACEPTION
Combination oral contraceptives act by suppression of gonadotropins.
Although the primary
mechanism of this action is inhibition of ovulation, other alterations
include changes in the
cervical mucus (which increase the difficulty of sperm entry into the
uterus) and the
endometrium (which reduce the likelihood of implantation).
Receptor binding studies, as well as studies in animals and humans,
have shown that
norgestimate and 17-deacetyl norgestimate (norelgestromin), the major
serum metabolite,
combine high progestational activity with minimal intrinsic
androgenicity. Norgestimate, in
combination with ethinyl estradiol, does not counteract the
estrogen-induced increases in sex
hormone binding globulin (SHBG), resulting in lower serum
testosterone.
INDICATIONS AND CLINICAL USE
CENTRISA
™
LO Tablets are indicated for conception control.
In an active controlled clinical trial including 1,673 subjects
completing 11,003 cycles of
CENTRISA
™
LO use, a total of 20 pregnancies were reported among CENTRISA
™
LO us