MARVELON 28 TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ETHINYL ESTRADIOL; DESOGESTREL

Dostupné s:

ORGANON CANADA INC.

ATC kód:

G03AA09

INN (Mezinárodní Name):

DESOGESTREL AND ESTROGEN

Dávkování:

0.03MG; 0.15MG

Léková forma:

TABLET

Složení:

ETHINYL ESTRADIOL 0.03MG; DESOGESTREL 0.15MG

Podání:

ORAL

Jednotky v balení:

28

Druh předpisu:

Prescription

Terapeutické oblasti:

CONTRACEPTIVES

Přehled produktů:

Active ingredient group (AIG) number: 0224591001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2009-10-01

Charakteristika produktu

_MARVELON (desogestrel and ethinyl estradiol) _
_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MARVELON
® 21 AND
MARVELON
® 28
Desogestrel and Ethinyl estradiol Tablets
Tablets 0.15 mg Desogestrel and 0.03 mg Ethinyl estradiol, Oral
USP
Oral Contraceptive
Organon Canada Inc.
16766 Trans-Canada highway
Kirkland QC H9H 4M7
Date of Initial Approval:
July 13, 1993
Date of Revision:
July 07, 2022
Submission Control No: 261227
_ _
_MARVELON (desogestrel and ethinyl estradiol) _
_Page 2 of 56_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATION
07-2022
7 Warnings and Precautions
07-2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
2
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS.............................................................................................................
4
1.1
Pediatrics.........................................................................................................
4
1.2
Geriatrics
.........................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX..................................................... 5
4
DOSAGE AND ADMINISTRATION
.............................................................................
5
4.1
Dosing Considerations
.....................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.................................................. 5
4.4
Administration
..................................................................