FOLIC ACID TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FOLIC ACID

Available from:

AA PHARMA INC

ATC code:

B03BB01

INN (International Name):

FOLIC ACID

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

FOLIC ACID 5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

VITAMIN B COMPLEX

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2018-11-23

Summary of Product characteristics

_FOLIC ACID (folic acid) _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FOLIC ACID
Folic acid
Tablets, 5 mg, Oral
BP
ATC code: B03BB01
Anemia Therapy
AA Pharma Inc.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4k 4N7
www.aapharma.ca
Date of Initial Authorization:
NOV 23, 2018
Date of Revision:
APR 7, 2022
Submission Control Number: 258037
_ _
_FOLIC ACID (folic acid) _
_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
1 Indications
04/2022
1 Indications, 1.1 Pediatrics
04/2022
2 Contraindications
04/2022
4 Dosage and Administration, 4.1 Dosage considerations
04/2022
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
04/2022
7 Warnings and Precautions
04/2022
7 Warnings and Precautions, 7.1.1 Pregnant women
04/2022
7 Warnings and Precautions, 7.1.2 Breast-feeding
04/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
04/2022
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
..................................................