MIRVALA 21 TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DESOGESTREL; ETHINYL ESTRADIOL

Pieejams no:

APOTEX INC

ATĶ kods:

G03AA09

SNN (starptautisko nepatentēto nosaukumu):

DESOGESTREL AND ESTROGEN

Deva:

0.1500MG; 0.0300MG

Zāļu forma:

TABLET

Kompozīcija:

DESOGESTREL 0.1500MG; ETHINYL ESTRADIOL 0.0300MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

21 TABS

Receptes veids:

Prescription

Ārstniecības joma:

CONTRACEPTIVES

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2013-08-07

Produkta apraksts

_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