MIRVALA 28 TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DESOGESTREL; ETHINYL ESTRADIOL

Disponibil de la:

APOTEX INC

Codul ATC:

G03AA09

INN (nume internaţional):

DESOGESTREL AND ESTROGEN

Dozare:

0.1500MG; 0.0300MG

Forma farmaceutică:

TABLET

Compoziție:

DESOGESTREL 0.1500MG; ETHINYL ESTRADIOL 0.0300MG

Calea de administrare:

ORAL

Unități în pachet:

28 TABS

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CONTRACEPTIVES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2013-08-07

Caracteristicilor produsului

_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