TEVA-SUMATRIPTAN TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE)

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

N02CC01

INN (Algemene Internationale Benaming):

SUMATRIPTAN

Dosering:

100MG

farmaceutische vorm:

TABLET

Samenstelling:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 100MG

Toedieningsweg:

ORAL

Eenheden in pakket:

6

Prescription-type:

Prescription

Therapeutisch gebied:

SELECTIVE SEROTONIN AGONISTS

Product samenvatting:

Active ingredient group (AIG) number: 0123238001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2011-06-14

Productkenmerken

TEVA-SUMATRIPTAN
Page 1 of 44
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-SUMATRIPTAN
Sumatriptan Succinate Tablets
Tablets, 100 mg sumatriptan (as sumatriptan succinate), Oral
PR
TEVA-SUMATRIPTAN DF
Sumatriptan Succinate Tablets
Tablets, 25 mg, 50 mg and 100 mg sumatriptan (as sumatriptan
succinate), Oral
Teva Standard
5-HT
1
Receptor Agonist
Migraine Therapy
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control Number: 261898
Date of Initial Authorization:
June 28, 2011
Date of Revision:
August 10, 2022
Page 2 of 44
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
08/2022
7 Warnings and Precautions, Serotonin toxicity / Serotonin Syndrome
08/2022
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
...................................................................................................................
4
2
CONTRAINDICATIONS............................................................................................................
4
4 DOSAGE AND ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
................................................................................................
5