NAT-ERLOTINIB TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
15-07-2020
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Aktívna zložka:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
Dostupné z:
NATCO PHARMA (CANADA) INC
ATC kód:
L01EB02
INN (Medzinárodný Name):
ERLOTINIB
Dávkovanie:
100MG
Forma lieku:
TABLET
Zloženie:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100MG
Spôsob podávania:
ORAL
Počet v balení:
15G/50G
Typ predpisu:
Prescription
Terapeutické oblasti:
ANTINEOPLASTIC AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0151203002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2018-12-14
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
NAT-ERLOTINIB
Erlotinib hydrochloride tablets
25 mg, 100 mg and 150 mg
erlotinib
Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
Protein Kinase Inhibitor (L01XE03)
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1,
Suite 200
Mississauga, Ontario, Canada
L5N 1P7
Date of Revision:
July15, 2020
SUBMISSION CONTROL NO: 238581
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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
.................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 20
STORAGE AND STABILITY
..........................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
........................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
..........................................................................
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