EVRA PATCH (EXTENDED RELEASE)

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

NORELGESTROMIN; ETHINYL ESTRADIOL

Fáanlegur frá:

SEARCHLIGHT PHARMA INC

ATC númer:

G03AA13

INN (Alþjóðlegt nafn):

NORELGESTROMIN AND ESTROGEN

Skammtar:

200MCG; 35MCG

Lyfjaform:

PATCH (EXTENDED RELEASE)

Samsetning:

NORELGESTROMIN 200MCG; ETHINYL ESTRADIOL 35MCG

Stjórnsýsluleið:

TRANSDERMAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

CONTRACEPTIVES

Vörulýsing:

Active ingredient group (AIG) number: 0248061003; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2003-11-19

Vara einkenni

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_Page 1 of 76 _
PRODUCT MONOGRAPH
PR
EVRA
®
6 mg norelgestromin and 0.6 mg ethinyl estradiol
Transdermal System
(Each transdermal system releases approximately 200 μg norelgestromin
and 35 μg ethinyl estradiol per 24 hours)
Hormonal Contraceptive
Searchlight Pharma Inc.
1600 Notre-Dame West, Suite 312
Montreal, Quebec
H3J 1M1
www.searchlightpharma.ca
SUBMISSION CONTROL NO.: 262575
All trademarks used under license.
© 2021 Gedeon Richter Plc
Date of Preparation:
April 28, 2022
_ _
_Page 2 of 76 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................16
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................31
OVERDOSAGE
................................................................................................................36
ACTION AND CLINICAL PHARMACOLOGY
............................................................37
STORAGE AND STABILITY
..........................................................................................45
SPECIAL HANDLING INSTRUCTIONS
.......................................................................46
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................46
PART II: SCIENTIFIC INFORMATION
............................................................................