ZOLMITRIPTAN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ZOLMITRIPTAN

Dostopno od:

PRO DOC LIMITEE

Koda artikla:

N02CC03

INN (mednarodno ime):

ZOLMITRIPTAN

Odmerek:

2.5MG

Farmacevtska oblika:

TABLET

Sestava:

ZOLMITRIPTAN 2.5MG

Pot uporabe:

ORAL

Enote v paketu:

6/30

Tip zastaranja:

Prescription

Terapevtsko območje:

SELECTIVE SEROTONIN AGONISTS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2021-04-07

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
ZOLMITRIPTAN
Zolmitriptan Film-Coated Tablets, House Standard
2.5 mg
PR
ZOLMITRIPTAN ODT
Zolmitriptan Orally Dispersible Tablets, House Standard
2.5 mg
5-HT1 RECEPTOR AGONIST
MIGRAINE THERAPY
DATE OF REVISION:
MARCH 4, 2021
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
Submission Control No.: 248801
Zolmitriptan
Zolmitriptan PM-E.pdf
Pg. 1
_ _
_ZOLMITRIPTAN and ZOLMITRIPTAN ODT Product Monograph _
_Page 2 of 41 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
............................................................................................
12
DRUG INTERACTIONS
..............................................................................................
18
DOSAGE AND ADMINISTRATION
...........................................................................
20
OVERDOSAGE
............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 22
STORAGE AND STABILITY
......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 25
PART II: SCIENTIFIC INFORMATION
............................................................................
26
PHARMACEUTICAL
INFORMATION.......................................................................
26
CLINICAL
TRIALS........................................................................