MYLAN-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
06-06-2013
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Aktivna sestavina:
ZOLMITRIPTAN
Dostopno od:
MYLAN PHARMACEUTICALS ULC
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:
6
Tip zastaranja:
Prescription
Terapevtsko območje:
SELECTIVE SEROTONIN AGONISTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0134381001; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2018-07-12
Lastnosti izdelka
Page 1 of
33
PRODUCT MONOGRAPH
PR MYLAN-ZOLMITRIPTAN ODT
zolmitriptan orally disintegrating tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No: 162280
Date of Revision: May 17, 2013
Page 2 of
33
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
...............................................................................................
10
DRUG INTERACTIONS
...............................................................................................
14
DOSAGE AND ADMINISTRATION
...........................................................................
15
OVERDOSAGE
.............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 17
STORAGE AND STABILITY
.......................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 20
PART II: SCIENTIFIC INFORMATION
.....................................................................
21
PHARMACEUTICAL INFORMATION
..........................................................................
21
CLINICAL TRIALS
.......................................................................................................
22
DETAILED PHARMACOLOGY
..................................................................................
24
TOXICOLOGY
.................
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