TAPAZOLE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHIMAZOLE

Available from:

PALADIN LABS INC.

ATC code:

H03BB02

INN (International Name):

THIAMAZOLE

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

METHIMAZOLE 20MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTITHYROID AGENTS

Product summary:

Active ingredient group (AIG) number: 0104552002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2021-07-28

Summary of Product characteristics

_Tapazole_
_®_
_ (methimazole tablets) Product Monograph _
_Page 1 of 17_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TAPAZOLE®
Methimazole
Tablets, 5, 10 and 20 mg, oral
USP
ATC Code: H03BB02
Antithyroid Agent
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
Saint-Laurent, Quebec, Canada
H4M 2P2
paladinlabs.com
_ _
Date of Initial Authorization:
December 31, 1951
Date of Revision:
June 08, 2021
Version 7.0
Submission Control Number: 246350
_ _
_Tapazole_
_®_
_ (methimazole tablets) Product Monograph _
_Page 2 of 17_
RECENT MAJOR LABEL CHANGES
2 Contraindications
11/2019
7 Warnings and Precautions
06/2021
7 Warnings and Precautions, 7.1.1 Pregnant Women
11/2019
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
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment..................................................... 4
4.4
Administration....................................................