Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
DARUNAVIR
MYLAN PHARMACEUTICALS ULC
J05AE10
DARUNAVIR
600MG
TABLET
DARUNAVIR 600MG
ORAL
60/100
Prescription
HIV PROTEASE INHIBITORS
Active ingredient group (AIG) number: 0151656003; AHFS:
CANCELLED PRE MARKET
2022-01-27
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 .......................................................... Prečítajte si celý dokument