MYLAN-EFAVIRENZ TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
15-02-2021
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Aktiv bestanddel:
EFAVIRENZ
Tilgængelig fra:
MYLAN PHARMACEUTICALS ULC
ATC-kode:
J05AG03
INN (International Name):
EFAVIRENZ
Dosering:
600MG
Lægemiddelform:
TABLET
Sammensætning:
EFAVIRENZ 600MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/100
Recept type:
Prescription
Terapeutisk område:
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0137031005; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2013-07-30
Produktets egenskaber
_ _
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
.................................................................
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