APO-ERLOTINIB TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Доступна з:

APOTEX INC

Код атс:

L01EB02

ІПН (Міжнародна Ім'я):

ERLOTINIB

Дозування:

150MG

Фармацевтична форма:

TABLET

Склад:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30/100/500

Тип рецепту:

Prescription

Терапевтична области:

ANTINEOPLASTIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0151203003; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2017-03-09

Характеристики продукта

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PRODUCT MONOGRAPH
Pr
APO-ERLOTINIB
Erlotinib Hydrochloride tablets
Erlotinib, 25 mg, 100 mg, 150 mg
Protein Kinase Inhibitor (L01XE03)
Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada, M9L 1T9
Date of Revision:
December 5, 2018
SUBMISSION CONTROL NO: 221870
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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
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
16
DOSAGE AND ADMINISTRATION
.....................................................................................
18
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 19
STORAGE AND STABILITY
.................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
........................