MINT-FROVATRIPTAN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

FROVATRIPTAN (FROVATRIPTAN SUCCINATE)

Tilgængelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

N02CC07

INN (International Name):

FROVATRIPTAN

Dosering:

2.5MG

Lægemiddelform:

TABLET

Sammensætning:

FROVATRIPTAN (FROVATRIPTAN SUCCINATE) 2.5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

SELECTIVE SEROTONIN AGONISTS

Produkt oversigt:

Active ingredient group (AIG) number: 0150262001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2020-12-15

Produktets egenskaber

MINT-FROVATRIPTAN (frovatriptan succinate tablets)
Page 1 of 30
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-FROVATRIPTAN
Frovatriptan succinate tablets
Tablets, 2.5 mg frovatriptan (as frovatriptan succinate monohydrate),
Oral
Migraine Therapy
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
December 11, 2020
Date of Revision:
JUL 07, 2023
Submission Control Number: 275024
MINT-FROVATRIPTAN (frovatriptan succinate tablets)
Page 2 of 30
RECENT MAJOR LABEL CHANGES
Not Applicable
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
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 5
4.4
Administration
............................................................................................................
6
5
OVERDOSAGE
........................