CCP-ANASTROZOLE TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
22-06-2017
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Aktivní složka:
ANASTROZOLE
Dostupné s:
CELLCHEM PHARMACEUTICALS INC.
ATC kód:
L02BG03
INN (Mezinárodní Name):
ANASTROZOLE
Dávkování:
1MG
Léková forma:
TABLET
Složení:
ANASTROZOLE 1MG
Podání:
ORAL
Jednotky v balení:
30/100/1000
Druh předpisu:
Prescription
Terapeutické oblasti:
ANTINEOPLASTIC AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0128681001; AHFS:
Stav Autorizace:
CANCELLED POST MARKET
Datum autorizace:
2023-08-03
Charakteristika produktu
CCP-ANASTROZOLE 1 mg Tablet
Page 1 of 46
PRODUCT MONOGRAPH
Pr
CCP-ANASTROZOLE
(anastrozole)
1 mg tablet
Non-Steroidal Aromatase Inhibitor
CellChem Pharmaceuticals Inc.,
30 Concourse Gate, Unit 1
Ottawa, Ontario
K2E 7V7
Date of Revision:
June 19, 2017
Submission Control # 205272
CCP-ANASTROZOLE 1 mg Tablet
Page 2 of 46
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
..........................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................................
3
CONTRAINDICATIONS
.....................................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................................
4
ADVERSE
REACTIONS......................................................................................................................
6
DRUG INTERACTIONS
....................................................................................................................
16
DOSAGE AND ADMINISTRATION
................................................................................................
18
OVERDOSAGE
..................................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................
19
STORAGE AND STABILITY
............................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................................... 21
PART II: SCIENTIFIC INFORMATION
.........................
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