NAT-ERLOTINIB TABLET
Država: Kanada
Jezik: engleski
Izvor: Health Canada
Svojstava lijeka
(SPC)
15-07-2020
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Pošalji zahtjev.
Pošalji zahtjev.
Aktivni sastojci:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
Dostupno od:
NATCO PHARMA (CANADA) INC
ATC koda:
L01EB02
INN (International ime):
ERLOTINIB
Doziranje:
100MG
Farmaceutski oblik:
TABLET
Sastav:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100MG
Administracija rute:
ORAL
Jedinice u paketu:
15G/50G
Tip recepta:
Prescription
Područje terapije:
ANTINEOPLASTIC AGENTS
Proizvod sažetak:
Active ingredient group (AIG) number: 0151203002; AHFS:
Status autorizacije:
APPROVED
Datum autorizacije:
2018-12-14
Svojstava lijeka
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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