JAMP ATAZANAVIR CAPSULE
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
26-02-2021
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Aktivna sestavina:
ATAZANAVIR (ATAZANAVIR SULFATE)
Dostopno od:
JAMP PHARMA CORPORATION
Koda artikla:
J05AE08
INN (mednarodno ime):
ATAZANAVIR
Odmerek:
150MG
Farmacevtska oblika:
CAPSULE
Sestava:
ATAZANAVIR (ATAZANAVIR SULFATE) 150MG
Pot uporabe:
ORAL
Enote v paketu:
15G/50G
Tip zastaranja:
Prescription
Terapevtsko območje:
HIV PROTEASE INHIBITORS
Povzetek izdelek:
Active ingredient group (AIG) number: 0149741002; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2021-03-04
Lastnosti izdelka
Page 1 of 77
PRODUCT MONOGRAPH
PR
JAMP ATAZANAVIR
Atazanavir capsules
150, 200 and 300 mg
(as atazanavir sulfate)
House Standard
Azapeptide Inhibitor of HIV-1 Protease
JAMP Pharma Corporation
Date of Preparation:
1310, rue Nobel
February 26, 2021
Boucherville, Québec
J4B 5H3
CONTROL NUMBER: 231176
Page 2 of 77
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
....................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
...............................................................................37
OVERDOSAGE
.................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
.............................................................40
STORAGE AND STABILITY
..........................................................................................45
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................45
PART II : SCIENTIFIC INFORMATION
................................................................................46
PHARMACEUTICAL INFORMATION
..........................................................................46
CLINICAL TRIALS
..........................................................................................................46
DETAILED
PHARMACOLOGY.....................................
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