TEVA-ZOLMITRIPTAN OD TABLET (ORALLY DISINTEGRATING)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ZOLMITRIPTAN

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

N02CC03

INN (International ime):

ZOLMITRIPTAN

Doziranje:

2.5MG

Farmaceutski oblik:

TABLET (ORALLY DISINTEGRATING)

Sastav:

ZOLMITRIPTAN 2.5MG

Administracija rute:

ORAL

Jedinice u paketu:

2/6

Tip recepta:

Prescription

Područje terapije:

SELECTIVE SEROTONIN AGONISTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2011-06-07

Svojstava lijeka

PRODUCT MONOGRAPH
PR
TEVA-ZOLMITRIPTAN
(zolmitriptan) tablets
2.5 mg
PR
TEVA-ZOLMITRIPTAN OD
(zolmitriptan) orally disintegrating tablets
2.5 mg
Teva Standard
Migraine Therapy
5-HT
1
Receptor Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 237687
Date of Revision:
April 6, 2020
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
19
OVERDOSAGE
.......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 21
STORAGE AND STABILITY
.................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL TRIALS
...........................................