JAMP METHIMAZOLE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHIMAZOLE

Available from:

JAMP PHARMA CORPORATION

ATC code:

H03BB02

INN (International Name):

THIAMAZOLE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

METHIMAZOLE 5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTITHYROID AGENTS

Product summary:

Active ingredient group (AIG) number: 0104552001; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-07-17

Summary of Product characteristics

JAMP Methimazole (methimazole tablets) Product Monograph Page 1 of 22
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR JAMP METHIMAZOLE
Methimazole Tablets, 5 mg and 10 mg, oral
USP
Antithyroid Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
Canada, J4B 5H3
Date of Initial Authorization:
July 17, 2019
Date of Revision:
September 28, 2023
Submission Control Number: 275872
JAMP Methimazole (methimazole tablets) Product Monograph Page 2 of 22
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
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4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.4
Administration
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