MIRVALA 28 TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

DESOGESTREL; ETHINYL ESTRADIOL

Inapatikana kutoka:

APOTEX INC

ATC kanuni:

G03AA09

INN (Jina la Kimataifa):

DESOGESTREL AND ESTROGEN

Kipimo:

0.1500MG; 0.0300MG

Dawa fomu:

TABLET

Tungo:

DESOGESTREL 0.1500MG; ETHINYL ESTRADIOL 0.0300MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

28 TABS

Dawa ya aina:

Prescription

Eneo la matibabu:

CONTRACEPTIVES

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2013-08-07

Tabia za bidhaa

_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