MINT-FROVATRIPTAN TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Nusipirk tai dabar

Parsisiųsti Prekės savybės (SPC)
07-07-2023

Veiklioji medžiaga:

FROVATRIPTAN (FROVATRIPTAN SUCCINATE)

Prieinama:

MINT PHARMACEUTICALS INC

ATC kodas:

N02CC07

INN (Tarptautinis Pavadinimas):

FROVATRIPTAN

Dozė:

2.5MG

Vaisto forma:

TABLET

Sudėtis:

FROVATRIPTAN (FROVATRIPTAN SUCCINATE) 2.5MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Gydymo sritis:

SELECTIVE SEROTONIN AGONISTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2020-12-15

Prekės savybės

                                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
........................
                                
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