ZOLMITRIPTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ZOLMITRIPTAN

Tersedia dari:

JUBILANT GENERICS LIMITED

Kode ATC:

N02CC03

INN (Nama Internasional):

ZOLMITRIPTAN

Dosis:

2.5MG

Bentuk farmasi:

TABLET

Komposisi:

ZOLMITRIPTAN 2.5MG

Rute administrasi :

ORAL

Unit dalam paket:

6

Jenis Resep:

Prescription

Area terapi:

SELECTIVE SEROTONIN AGONISTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2014-01-21

Karakteristik produk

_Zolmitriptan _
_Page 1 of 31 _
PRODUCT MONOGRAPH
PR
ZOLMITRIPTAN
Zolmitriptan
Tablets, 2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
SPONSOR: DATE OF REVISION:
Jubilant Generics Limited
March 27, 2020
1A- Sector 16A, Institutional Area,
Noida, Uttar Pradesh, India, 201301
DISTRIBUTOR:
Pharmapar Inc.,
1565 Boul. Lionel- Boulet, Varennes
QC J3X 1P7
SUBMISSION CONTROL NO.: 237077
_Zolmitriptan _
_Page 2 of 31 _
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..............................................................................
17
OVERDOSAGE.................................................................................................................
18
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.......................................................................................