NU-OLANZAPINE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

OLANZAPINE

Доступно од:

NU-PHARM INC

АТЦ код:

N05AH03

INN (Међународно име):

OLANZAPINE

Дозирање:

5.0MG

Фармацеутски облик:

TABLET

Састав:

OLANZAPINE 5.0MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Prescription

Терапеутска област:

ATYPICAL ANTIPSYCHOTICS

Резиме производа:

Active ingredient group (AIG) number: 0128783003; AHFS:

Статус ауторизације:

CANCELLED (UNRETURNED ANNUAL)

Датум одобрења:

2018-03-28

Карактеристике производа

PRODUCT MONOGRAPH
PR
NU-OLANZAPINE
Olanzapine Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg
Antipsychotic Agent
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural Street, Units 1 & 2
OCTOBER 8, 2009
Richmond Hill, Ontario
L4B 1E4
Control No.: 121691
Page 2 of 57
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
.......................................................................................................
11
DRUG
INTERACTIONS........................................................................................................
25
DOSAGE AND ADMINISTRATION
...................................................................................
27
OVERDOSAGE......................................................................................................................
28
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
29
STORAGE AND STABILITY
..............................................................................................
31
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................... 31
PART II: SCIENTIFIC INFORMATION
.............................................................................
33
PHARMACEUTICAL INFORMATION
...............................................................................
33
CLINICAL TRIALS
...............................................................................................................
33
DETAILED PHARMACOLOGY
................................