NAT-ERLOTINIB TABLET
Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
15-07-2020
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
Disponibbli minn:
NATCO PHARMA (CANADA) INC
Kodiċi ATC:
L01EB02
INN (Isem Internazzjonali):
ERLOTINIB
Dożaġġ:
150MG
Għamla farmaċewtika:
TABLET
Kompożizzjoni:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
15G/50G
Tip ta 'preskrizzjoni:
Prescription
Żona terapewtika:
ANTINEOPLASTIC AGENTS
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0151203003; AHFS:
L-istatus ta 'awtorizzazzjoni:
APPROVED
Data ta 'l-awtorizzazzjoni:
2018-12-14
Karatteristiċi tal-prodott
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
..........................................................................
Aqra d-dokument sħiħ
