MARVELON 21 TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DESOGESTREL; ETHINYL ESTRADIOL

Διαθέσιμο από:

ORGANON CANADA INC.

Φαρμακολογική κατηγορία (ATC):

G03AA09

INN (Διεθνής Όνομα):

DESOGESTREL AND ESTROGEN

Δοσολογία:

0.15MG; 0.03MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

DESOGESTREL 0.15MG; ETHINYL ESTRADIOL 0.03MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

21

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CONTRACEPTIVES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2009-10-01

Αρχείο Π.Χ.Π.

_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
..................................................................