LETROZOLE TABLETS

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

LETROZOLE

Mevcut itibaren:

FRESENIUS KABI CANADA LTD

ATC kodu:

L02BG04

INN (International Adı):

LETROZOLE

Doz:

2.5MG

Farmasötik formu:

TABLET

Kompozisyon:

LETROZOLE 2.5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

14

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0132937001; AHFS:

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2023-03-10

Ürün özellikleri

PRODUCT MONOGRAPH
PR
LETROZOLE TABLETS
(letrozole)
2.5 mg
Manufacturer’s Standard
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100
November 10, 2017
Toronto, ON M9W 0C8
Submission Control No:
209100
_Letrozole-PM-ENG-v2.0 _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Page 2 of 62 _
_ _
_ _
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
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
27
DOSAGE AND ADMINISTRATION
.....................................................................................
28
OVERDOSAGE
........................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
30
STORAGE AND STABILITY
.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL INFORMATION
.................................................................................
33
CLINICAL