MYLAN-DARUNAVIR TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

DARUNAVIR

Beszerezhető a:

MYLAN PHARMACEUTICALS ULC

ATC-kód:

J05AE10

INN (nemzetközi neve):

DARUNAVIR

Adagolás:

800MG

Gyógyszerészeti forma:

TABLET

Összetétel:

DARUNAVIR 800MG

Az alkalmazás módja:

ORAL

db csomag:

30

Recept típusa:

Prescription

Terápiás terület:

HIV PROTEASE INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0151656006; AHFS:

Engedélyezési státusz:

CANCELLED PRE MARKET

Engedély dátuma:

2022-01-27

Termékjellemzők

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MYLAN-DARUNAVIR
Darunavir Tablets
75 mg, 150 mg, 300 mg, 400 mg, 600 mg and 800 mg
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation:
June 21, 2019
Date of Revision:
Jan 2, 2020
Submission Control No: 163712, 187980, 205319, 213903, 218251, 228649
2 | 90
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...................................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................................
3
CONTRAINDICATIONS
............................................................................................................
4
WARNINGS AND
PRECAUTIONS...........................................................................................
5
ADVERSE REACTIONS
..........................................................................................................
10
DRUG INTERACTIONS
...........................................................................................................
21
DOSAGE AND ADMINISTRATION
...........................................................................................
OVERDOSAGE
.............................................................................................................................
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
STORAGE AND
STABILITY.......................................................................................................
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................................
PART II: SCIENTIFIC INFORMATION
.............................................................................................
PHARMACEUTICAL INFORMATION
......................................................................................
CLINICAL TRIALS
..........................................................