Country: Canada
Language: English
Source: Health Canada
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
MYLAN PHARMACEUTICALS ULC
J05AR06
EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ
600MG; 200MG; 300MG
TABLET
EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG
ORAL
30
Prescription
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Active ingredient group (AIG) number: 0352327001; AHFS:
APPROVED
2017-07-26
PAGE 1 OF 75 PRODUCT MONOGRAPH PR MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG EFAVIRENZ 200 MG EMTRICITABINE 300 MG TENOFOVIR DISOPROXIL FUMARATE MYLAN STD. ANTIRETROVIRAL AGENT Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Revision: July 27, 2020 Submission Control No: 241548 PAGE 2 OF 75 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................................ 3 SUMMARY PRODUCT INFORMATION .............................................................................................................. 3 INDICATIONS AND CLINICAL USE .................................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................................ 3 WARNINGS AND PRECAUTIONS ....................................................................................................................... 5 ADVERSE REACTIONS ....................................................................................................................................... 15 DRUG INTERACTIONS ....................................................................................................................................... 24 DOSAGE AND ADMINISTRATION.................................................................................................................... 40 OVERDOSAGE ..................................................................................................................................................... 41 ACTION AND CLINICAL PHARMACOLOGY .................................................................................................. 42 STORAGE AND STABILITY ....................................................................................................................... Read the complete document