MYLAN-DARUNAVIR TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DARUNAVIR

Pieejams no:

MYLAN PHARMACEUTICALS ULC

ATĶ kods:

J05AE10

SNN (starptautisko nepatentēto nosaukumu):

DARUNAVIR

Deva:

75MG

Zāļu forma:

TABLET

Kompozīcija:

DARUNAVIR 75MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

HIV PROTEASE INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0151656004; AHFS:

Autorizācija statuss:

CANCELLED PRE MARKET

Autorizācija datums:

2022-01-27

Produkta apraksts

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
..........................................................