ATHENA-ONDANSETRON ODT TABLET (ORALLY DISINTEGRATING)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ONDANSETRON

Available from:

ATHENA PHARMACEUTIQUES SAS

ATC code:

A04AA01

INN (International Name):

ONDANSETRON

Dosage:

8MG

Pharmaceutical form:

TABLET (ORALLY DISINTEGRATING)

Composition:

ONDANSETRON 8MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

5-HT3 RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0131120001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-06-21

Summary of Product characteristics

_Product Monograph _
_Athena-Ondansetron ODT (ondansetron) _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATHENA-ONDANSETRON ODT
Ondansetron orally disintegrating tablets
Orally disintegrating tablets, 4 mg and 8 mg, oral
Manufacturer Standard
Antiemetic
5-HT
3
receptor antagonist
ATC code A04AA01
Athena Pharmaceutiques SAS
Espace Arnold de Ville,
12 rue Georges Blandon,
78430 Louveciennes,
France
Date of Initial Authorization:
JUN 21, 2021
Date of Revision:
JAN 17, 2022
Imported by:
Athena Canada Inc.
Vaughan, Ontario
L4K 3P3
Submission Control Number: 255400_ _
_Product Monograph _
_Athena-Ondansetron ODT (ondansetron) _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
01/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
01/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular, Myocardial
Ischemia and Coronary Artery Spasm
01/2022
7 WARNING AND PRECAUTIONS, Special Populations, 7.1.1 Pregnant
Women
01/2022
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 (< 18 years of age)
.................................................................. 4
1.2
Geriatrics (≥ 65 years of age)
.................................................................. 4
2
CONTRAINDICATIONS................................................................................................
4
4
DOSAGE AND ADMINISTRATION
...............................................................................
5
4.1
Dosing
Considerations............................