NAT-ERLOTINIB TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
15-07-2020
Nogle dokumenter til dette produkt er ikke tilgængelige i øjeblikket, du kan sende en anmodning til vores kundeservice, og vi vil underrette dig, så snart vi er i stand til at få dem.
Send anmodning.
Send anmodning.
Aktiv bestanddel:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
Tilgængelig fra:
NATCO PHARMA (CANADA) INC
ATC-kode:
L01EB02
INN (International Name):
ERLOTINIB
Dosering:
150MG
Lægemiddelform:
TABLET
Sammensætning:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG
Indgivelsesvej:
ORAL
Enheder i pakken:
15G/50G
Recept type:
Prescription
Terapeutisk område:
ANTINEOPLASTIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0151203003; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2018-12-14
Produktets egenskaber
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
_Page 2 of 48_
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
..........................................................................
Læs hele dokumentet
