SANDOZ FOLIC ACID TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FOLIC ACID

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

B03BB01

INN (International Name):

FOLIC ACID

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

FOLIC ACID 5MG

Administration route:

ORAL

Units in package:

1000

Prescription type:

Prescription

Therapeutic area:

VITAMIN B COMPLEX

Product summary:

Active ingredient group (AIG) number: 0108418001; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-08-18

Summary of Product characteristics

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_Sandoz Folic Acid (folic acid) _
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_Page 1 of 24 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ® FOLIC ACID
Folic acid tablets USP
Tablets, 5 mg, Oral
USP
ATC code: B03BB01
Anemia Therapy
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Initial Authorization:
November 27, 2006
Date of Revision:
November 18, 2022
Submission Control Number: 265016
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_Sandoz Folic Acid (folic acid) _
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_Page 2 of 24 _
RECENT MAJOR LABEL CHANGES
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
...................................................................................................................
5
2 CONTRAINDICATIONS
............................................................................................................5
4 DOSAGE AND ADMINISTRATION
.............................................................................................5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Ad