CO LETROZOLE TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
29-06-2011
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有効成分:
LETROZOLE
から入手可能:
COBALT PHARMACEUTICALS COMPANY
ATCコード:
L02BG04
INN（国際名）:
LETROZOLE
投薬量:
2.5MG
医薬品形態:
TABLET
構図:
LETROZOLE 2.5MG
投与経路:
ORAL
パッケージ内のユニット:
30
処方タイプ:
Prescription
治療領域:
ANTINEOPLASTIC AGENTS
製品概要:
Active ingredient group (AIG) number: 0132937001; AHFS:
認証ステータス:
CANCELLED PRE MARKET
承認日:
2017-09-01
製品の特徴
Page 1 of 57
PRODUCT MONOGRAPH
PR _CO_ LETROZOLE
(Letrozole Tablets USP)
2.5 mg
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
Cobalt Pharmaceuticals Company
Date of Revision:
6500 Kitimat Road,
June 21, 2011
Mississauga, ON
Canada, L5N 2B8
Submission Control No.: 146839
Page 2 of 57
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
.......................................................................................
24
DOSAGE AND
ADMINISTRATION...................................................................
25
OVERDOSAGE
.....................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
................................................. 26
STORAGE AND
STABILITY...............................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................. 28
PART II: SCIENTIFIC INFORMATION
....................................................................
30
PHARMACEUTICAL
INFORMATION...............................................................
30
CLINICAL
TRIALS...............................................................................................
31
DETAILED
PHARMACOLOGY..........................................................................
44
TOXICOLOGY
...................................................................................................
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