ZOMIG TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ZOLMITRIPTAN

Dostopno od:

XEDITON PHARMACEUTICALS INC

Koda artikla:

N02CC03

INN (mednarodno ime):

ZOLMITRIPTAN

Odmerek:

2.5MG

Farmacevtska oblika:

TABLET

Sestava:

ZOLMITRIPTAN 2.5MG

Pot uporabe:

ORAL

Enote v paketu:

3/6

Tip zastaranja:

Prescription

Terapevtsko območje:

SELECTIVE SEROTONIN AGONISTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2023-01-11

Lastnosti izdelka

Page 1 of 47
PRODUCT MONOGRAPH
ZOMIG
®
zolmitriptan tablets
2.5 mg
ZOMIG RAPIMELT
®
zolmitriptan orally disintegrating tablets
2.5 mg
ZOMIG
® NASAL SPRAY
zolmitriptan nasal spray
2.5 and 5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Xediton Pharmaceuticals Inc.
2020 Winston Park Drive, Suite 402
Oakville, Ontario
L6H 6X7
www.xediton.com
Submission Control No.: 270277
ZOMIG
®
and ZOMIG RAPIMELT
®
are registered trademarks of Grünenthal GmbH, used under
license by Xediton Pharmaceuticals Inc.
Pr
Pr
Pr
Date of
Preparation:
JAN
9,
2023
Page 2 of 47
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
...............................................................................................
11
DRUG INTERACTIONS
...............................................................................................
19
DOSAGE AND ADMINISTRATION
...........................................................................
20
OVERDOSAGE
..............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 22
STORAGE AND STABILITY
.......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 26
PART II: SCIENTIFIC INFORMATION
.............................................................................
27
PHARMACEUTICAL INFORMATION
...........................................