Country: Canada
Language: English
Source: Health Canada
CANDESARTAN CILEXETIL
BIOMED PHARMA
C09CA06
CANDESARTAN
16MG
TABLET
CANDESARTAN CILEXETIL 16MG
ORAL
30/100
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0135220003; AHFS:
CANCELLED PRE MARKET
2022-07-19
_Bio-CANDESARTAN _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 35 _ _ _ PRODUCT MONOGRAPH PR BIO-CANDESARTAN Candesartan Cilexetil Tablets 4 mg, 8 mg, 16 mg and 32 mg Angiotensin II AT 1 Receptor Blocker BIOMED PHARMA DATE OF PREPARATION: 5950, Côte de Liesse, Suite 100 June 15, 2016 Ville Mont-Royal Québec H4T 1E2 SUBMISSION CONTROL #: 194909 _Bio-CANDESARTAN _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 35 _ _ _ TABLE OF CONTENTS CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................................... 3 CONTRAINDICATIONS .......................................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................................... 4 ADVERSE REACTIONS ........................................................................................................................... 8 DRUG INTERACTIONS ......................................................................................................................... 13 DOSAGE AND ADMINISTRATION ..................................................................................................... 16 OVERDOSAGE ....................................................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY.................................................................................... 19 STORAGE AND STABILITY ................................................................................................................. 21 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................................... 22 Read the complete document