MINT-FROVATRIPTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

FROVATRIPTAN (FROVATRIPTAN SUCCINATE)

Tersedia dari:

MINT PHARMACEUTICALS INC

Kode ATC:

N02CC07

INN (Nama Internasional):

FROVATRIPTAN

Dosis:

2.5MG

Bentuk farmasi:

TABLET

Komposisi:

FROVATRIPTAN (FROVATRIPTAN SUCCINATE) 2.5MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

SELECTIVE SEROTONIN AGONISTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-12-15

Karakteristik produk

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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
............................................................................................................
4
1.1
Pediatrics
....................................................................................................................
4
1.2
Geriatrics
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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
........................