AG-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ZOLMITRIPTAN

Boleh didapati daripada:

ANGITA PHARMA INC.

Kod ATC:

N02CC03

INN (Nama Antarabangsa):

ZOLMITRIPTAN

Dos:

2.5MG

Borang farmaseutikal:

TABLET (ORALLY DISINTEGRATING)

Komposisi:

ZOLMITRIPTAN 2.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

6

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE SEROTONIN AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0134381001; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2022-09-02

Ciri produk

_AG-ZOLMITRIPTAN ODT _
_Page 1 of 33_
PRODUCT MONOGRAPH
PR AG-ZOLMITRIPTAN ODT
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Angita Pharma Inc.
1380-203 newton
Boucherville, QuébecJ4B 5H2
DATE OF PREPARATION:
March 13, 2015
SUBMISSION CONTROL NO.: 182554
_AG-ZOLMITRIPTAN ODT _
_Page 2 of 33_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.................................................
3
SUMMARY PRODUCT
INFORMATION.....................................................................
3
INDICATIONS AND CLINICAL
USE............................................................................
3
CONTRAINDICATIONS..................................................................................................
3
WARNINGS AND
PRECAUTIONS................................................................................
4
ADVERSE
REACTIONS..................................................................................................
10
DRUG
INTERACTIONS..................................................................................................
15
DOSAGE AND
ADMINISTRATION..............................................................................
16
OVERDOSAGE.................................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY.............................................................
18
STORAGE AND
STABILITY..........................................................................................
20
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................
20
PART II: SCIENTIFIC
INFORMATION.........................................................................
21
PHARMACEUTICAL
INFORMATION..........................................................................
21
CLINICAL
TRIALS..........................................................................................................
21
DETAILED
PHARMACOLOGY.......................................