TEVA-ZOLMITRIPTAN OD TABLET (ORALLY DISINTEGRATING)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Cumpara asta acum

Ingredient activ:

ZOLMITRIPTAN

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

N02CC03

INN (nume internaţional):

ZOLMITRIPTAN

Dozare:

1MG

Forma farmaceutică:

TABLET (ORALLY DISINTEGRATING)

Compoziție:

ZOLMITRIPTAN 1MG

Calea de administrare:

ORAL

Unități în pachet:

2/6

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

SELECTIVE SEROTONIN AGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0134381003; AHFS:

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2015-10-16

Caracteristicilor produsului

                                PRODUCT MONOGRAPH
PR
TEVA-ZOLMITRIPTAN
(zolmitriptan) tablets
1 mg and 2.5 mg
PR
TEVA-ZOLMITRIPTAN OD
(zolmitriptan) orally disintegrating tablets
1 mg and 2.5 mg
Professed Standard
Migraine Therapy
5-HT
1
Receptor Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 176520
Date of Revision:
July 31, 2014
2
TABLE OF CONTENTS
PRODUCT MONOGRAPH
........................................................................................................
1
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
11
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:
                                
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