MYLAN-EFAVIRENZ TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

EFAVIRENZ

Commercializzato da:

MYLAN PHARMACEUTICALS ULC

Codice ATC:

J05AG03

INN (Nome Internazionale):

EFAVIRENZ

Dosaggio:

600MG

Forma farmaceutica:

TABLET

Composizione:

EFAVIRENZ 600MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-07-30

Scheda tecnica

_ _
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
.................................................................