CYCLEN TABLETS (21 DAY)

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

NORGESTIMATE; ETHINYL ESTRADIOL

Saadav alates:

JANSSEN INC

ATC kood:

G03AA11

INN (Rahvusvaheline Nimetus):

NORGESTIMATE AND ESTROGEN

Annus:

0.25MG; 0.035MG

Ravimvorm:

TABLET

Koostis:

NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG

Manustamisviis:

ORAL

Ühikuid pakis:

21

Retsepti tüüp:

Prescription

Terapeutiline ala:

CONTRACEPTIVES

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2020-08-27

Toote omadused

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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
..............................................................................