PROPYLTHIOURACIL TABLETS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PROPYLTHIOURACIL

Available from:

PHEBRA CANADA INC

ATC code:

H03BA02

INN (International Name):

PROPYLTHIOURACIL

Dosage:

50MG

Pharmaceutical form:

TABLET

Composition:

PROPYLTHIOURACIL 50MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0103603001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-12-02

Summary of Product characteristics

PROPYLTHIOURACIL TABLETS (propylthiouracil)
Page 1 of 23
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PROPYLTHIOURACIL TABLETS
Propylthiouracil
Tablets, 50 mg, Oral
USP
ATC Code: H03BA02
Thyroid therapy
Phebra Canada Inc.
7171 Frederick-Banting, Suite 216
Montreal, QC
Canada, H4S 1Z9
Website: www.phebra.com/cae
Date of Initial Authorization:
December 2, 2021
Submission Control Number: 251552
_ _
PROPYLTHIOURACIL TABLETS (propylthiouracil)
Page 2 of 23
RECENT MAJOR LABEL CHANGES
SECTION
DATE
_None at time of authorization_
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.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.4
Administration................................................................................