MINT-OLANZAPINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

OLANZAPINE

Commercializzato da:

MINT PHARMACEUTICALS INC

Codice ATC:

N05AH03

INN (Nome Internazionale):

OLANZAPINE

Dosaggio:

15MG

Forma farmaceutica:

TABLET

Composizione:

OLANZAPINE 15MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

ATYPICAL ANTIPSYCHOTICS

Dettagli prodotto:

Active ingredient group (AIG) number: 0128783005; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-09-04

Scheda tecnica

PRODUCT MONOGRAPH
Pr
MINT-OLANZAPINE
Olanzapine Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg
House Standard
Antipsychotic Agent
Mint Pharmaceuticals Inc.
Date of Revision:
1093 Meyerside Drive, Unit 1
13 June 2017
Mississauga, Ontario
L5T 1J6 SUBMISSION CONTROL NO: 206312
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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
..............................................................................................
4
ADVERSE REACTIONS
..............................................................................................................
13
DRUG INTERACTIONS
..............................................................................................................
30
DOSAGE AND ADMINISTRATION
..........................................................................................
31
OVERDOSAGE
............................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
34
STORAGE AND STABILITY
......................................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 36
PART II: SCIENTIFIC INFORMATION
...................................................................................
38
PHARMACEUTICAL INFORMATION
......................................................................................
38
CLINICAL TRIALS
...............................