CYCLEN TABLETS (21 DAY)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

NORGESTIMATE; ETHINYL ESTRADIOL

Mevcut itibaren:

JANSSEN INC

ATC kodu:

G03AA11

INN (International Adı):

NORGESTIMATE AND ESTROGEN

Doz:

0.25MG; 0.035MG

Farmasötik formu:

TABLET

Kompozisyon:

NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG

Uygulama yolu:

ORAL

Paketteki üniteler:

21

Reçete türü:

Prescription

Terapötik alanı:

CONTRACEPTIVES

Ürün özeti:

Active ingredient group (AIG) number: 0213627001; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2020-08-27

Ürün özellikleri

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_Page 1 of 58 _
PRODUCT MONOGRAPH
PR
CYCLEN
®
norgestimate and ethinyl estradiol tablets, House Std.
0.250 mg norgestimate and 0.035 mg ethinyl estradiol Tablets
Oral Contraceptive
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
March 3, 2020
Submission Control No.: 235009
All trademarks used under license.
© 2019 Janssen Inc.
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_Page 2 of 58 _
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
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
26
OVERDOSAGE
.......................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 33
STORAGE AND STABILITY
.................................................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 34
PART II: SCIENTIFIC INFORMATION
...............................................................................
35
PHARMACEUTICAL INFORMATION
..............................................................................