TEVA-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
26-04-2017
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
OLANZAPINE
Inapatikana kutoka:
TEVA CANADA LIMITED
ATC kanuni:
N05AH03
INN (Jina la Kimataifa):
OLANZAPINE
Kipimo:
10MG
Dawa fomu:
TABLET (ORALLY DISINTEGRATING)
Tungo:
OLANZAPINE 10MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
30
Dawa ya aina:
Prescription
Eneo la matibabu:
ATYPICAL ANTIPSYCHOTICS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0128783002; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2017-11-28
Tabia za bidhaa
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PRODUCT MONOGRAPH
PR
TEVA-OLANZAPINE
(olanzapine)
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets
USP
PR
TEVA-OLANZAPINE ODT
(olanzapine)
TEVA STANDARD
5 mg and 10 mg orally disintegrating tablets
Antipsychotic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 203417
Revision Date: April 21, 2017
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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
..................................................................................................
15
DRUG
INTERACTIONS...................................................................................................
30
DOSAGE AND ADMINISTRATION
..............................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 34
STORAGE AND STABILITY
..........................................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 37
PART II: SCIENTIFIC INFORMATION
.................................................................................
39
PHARMACEUTICAL INFORMATION
..........................................................................
39
CLINICAL TRIALS
..........................................................................................................
40
DETAILE
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