MYLAN-EFAVIRENZ TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

EFAVIRENZ

제공처:

MYLAN PHARMACEUTICALS ULC

ATC 코드:

J05AG03

INN (International Name):

EFAVIRENZ

복용량:

600MG

약제 형태:

TABLET

구성:

EFAVIRENZ 600MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0137031005; AHFS:

승인 상태:

APPROVED

승인 날짜:

2013-07-30

제품 특성 요약

_ _
PRODUCT MONOGRAPH
Pr MYLAN-EFAVIRENZ
(efavirenz tablets)
600 mg
Antiretroviral Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
February 15, 2021
Submission Control No. 248541
Page 2 of 54
_ _
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
.....................................................................................................
11
DRUG INTERACTIONS
......................................................................................................
17
DOSAGE AND ADMINISTRATION
..................................................................................
23
OVERDOSAGE....................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 24
STORAGE AND STABILITY
..............................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 31
PART II: SCIENTIFIC INFORMATION
.........................................................................
33
PHARMACEUTICAL INFORMATION
..............................................................................
33
CLINICAL TRIALS
.............................................................................................................
34
DETAILED PHARMACOLOGY
.................................................................