MIRVALA 28 TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DESOGESTREL; ETHINYL ESTRADIOL

Dostupné z:

APOTEX INC

ATC kód:

G03AA09

INN (Medzinárodný Name):

DESOGESTREL AND ESTROGEN

Dávkovanie:

0.1500MG; 0.0300MG

Forma lieku:

TABLET

Zloženie:

DESOGESTREL 0.1500MG; ETHINYL ESTRADIOL 0.0300MG

Spôsob podávania:

ORAL

Počet v balení:

28 TABS

Typ predpisu:

Prescription

Terapeutické oblasti:

CONTRACEPTIVES

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2013-08-07

Súhrn charakteristických

_MIRVALA (Desogestrel and Ethinyl Estradiol Tablets) _
_ Page 1 of 67 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MIRVALA
® 21
PR
MIRVALA
®
28
Desogestrel and Ethinyl Estradiol Tablets
Tablets, 0.15 mg Desogestrel and 0.03 mg Ethinyl Estradiol, Oral
USP
Oral Contraceptive
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
AUG 07, 2013
Date of Revision:
JUL 25, 2023
Submission Control No: 272136
_MIRVALA (Desogestrel and Ethinyl Estradiol Tablets) _
_ Page 2 of 67 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2023
7 WARNINGS AND PRECAUTIONS
07/2023
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
......................................................... 6
4.4
Administr