País: Canadá
Língua: inglês
Origem: Health Canada
ALPRAZOLAM
JAMP PHARMA CORPORATION
N05BA12
ALPRAZOLAM
2MG
TABLET
ALPRAZOLAM 2MG
ORAL
100/500
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0115008004; AHFS:
CANCELLED PRE MARKET
2022-09-30
Page 1 of 39 PRODUCT MONOGRAPH JAMP ALPRAZOLAM 0.25 MG, 0.5 MG, 1 MG AND 2 MG ALPRAZOLAM TABLETS, USP ANXIOLYTIC – ANTIPANIC JAMP Pharma Corporation Date of Preparation: September 9, 2020 1310 rue Nobel Boucherville, Quebec J4B 5H3 SUBMISSION CONTROL NO.: 238480 Page 2 of 39 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................... 3 SUMMARY PRODUCT INFORMATION ................................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................................ 3 CONTRAINDICATIONS .............................................................................................................. 5 WARNINGS AND PRECAUTIONS ............................................................................................ 5 ADVERSE REACTIONS ............................................................................................................ 12 DRUG INTERACTIONS ............................................................................................................ 16 DOSAGE AND ADMINISTRATION ........................................................................................ 19 OVERDOSAGE ........................................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 21 STORAGE AND STABILITY .................................................................................................... 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................ 22 PART II: SCIENTIFIC INFORMATION ...................................................................... 24 PHARMACEUTICAL INFORMATION .................................................................................... 24 CLINICAL TRIALS .......................................................................................... Leia o documento completo