VAN-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
10-04-2015
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Aktivna sestavina:
ZOLMITRIPTAN
Dostopno od:
VANC PHARMACEUTICALS INC
Koda artikla:
N02CC03
INN (mednarodno ime):
ZOLMITRIPTAN
Odmerek:
2.5MG
Farmacevtska oblika:
TABLET (ORALLY DISINTEGRATING)
Sestava:
ZOLMITRIPTAN 2.5MG
Pot uporabe:
ORAL
Enote v paketu:
2X3
Tip zastaranja:
Prescription
Terapevtsko območje:
SELECTIVE SEROTONIN AGONISTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0134381001; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2019-08-07
Lastnosti izdelka
_VAN- Zolmitriptan ODT _
_Page 1 of 32_
PRODUCT MONOGRAPH
PR
VAN-ZOLMITRIPTAN ODT
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
MANUFACTURER AND DISTRIBUTOR:
DATE OF PREPARATION: MARCH 25, 2015
Vanc Pharmaceuticals Inc.
Unit-210, 2639 Viking Way
Richmond, BC V6V 3B7
www.vancpharm.com
SUBMISSION CONTROL NO.: 182332
_VAN- Zolmitriptan ODT _
_Page 2 of 32_
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..............................................................................
16
OVERDOSAGE.................................................................................................................
17
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..........................................................................................................
2
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