CENTRISA 28 TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

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

Disponível em:

PATRIOT A DIVISION OF JANSSEN INC

Código ATC:

G03AB11

DCI (Denominação Comum Internacional):

NORGESTIMATE AND ESTROGEN

Dosagem:

0.180MG; 0.035MG; 0.215MG; 0.035MG; 0.250MG; 0.035MG

Forma farmacêutica:

TABLET

Composição:

NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.035MG

Via de administração:

ORAL

Unidades em pacote:

28

Tipo de prescrição:

Prescription

Área terapêutica:

CONTRACEPTIVES

Resumo do produto:

Active ingredient group (AIG) number: 0636783002; AHFS:

Status de autorização:

CANCELLED PRE MARKET

Data de autorização:

2017-08-03

Características técnicas

_165350.doc _
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_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