APO-ERLOTINIB TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

L01EB02

INN (Διεθνής Όνομα):

ERLOTINIB

Δοσολογία:

150MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-03-09

Αρχείο Π.Χ.Π.

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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
........................