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Drugs and Health Products

Summary Basis of Decision (SBD) Documents: Drugs

The SBD documents explain why Health Canada authorized certain drugs for sale in Canada. The documents include regulatory, safety, effectiveness and quality (chemistry and manufacturing) considerations.

SBDs are published for New Drug Submissions that contain a new active substance(s) that were authorized after January 1, 2005. Health Canada will draft Phase II SBDs for all eligible drugs authorized as of September 1, 2012. Eligible products authorized before September 1, 2012, but on or after January 1, 2005, will have SBDs in the Phase I format.

The SBDs are organized alphabetically by product name. Use the following index, or see the list of SBDs for drugs below.

Reader's Guide

For an explanation of the information available in each section of a Phase I SBD, consult the Phase I Reader's Guide.

For an explanation of the information available in each section of a Phase II SBD, consult the Phase II Reader's Guide.

Other Resources

For up to date information on a particular product, readers should refer to the most recent Product Monograph, available on the searchable Drug Product Database.

For information related to Warnings, Recalls and Alerts, go to the MedEffect Canada web page.

Readers should refer to the Next link will take you to another Web site Food and Drugs Act and/or the Next link will take you to another Web site Food and Drug Regulations for more information about the regulation of drugs.

Readers may also wish to consult the Health Canada website for other policies and guidance documents related to drugs and drug submissions. In particular, readers may wish to refer to the Management of Drug Submissions Guidance.

List of Abbreviations.

Summary Basis of Decision Documents: Drugs

A

ABILIFY

ACTEMRA

ADCETRIS

ADEMPAS

AFINITOR

ALOXI

ALPROLIX

ALREX

ALTARGO

ALVESCO

AMITIZA

ANORO ELLIPTA

APIDRA

APTIOM

APTIVUS

AREPANRIX H1N1

AREPANRIX H5N1

ARZERRA

ATRIANCE

AUBAGIO

AVAMYS

AVASTIN

AZILECT

B

BANZEL

BARACLUDE

BASAGLAR

BENLYSTA

BERINERT

BESIVANCE

BEXSERO

BEXXAR

BLEXTEN

BLINCYTO

BOSULIF

BREO ELLIPTA

BRIDION

BRILINTA

BRIVLERA

BYETTA

BYSTOLIC

C

CAMPRAL

CANTRACE

CAPRELSA

CARBAGLU

CATENA

CAYSTON

CELSENTRI

CERVARIX

CHAMPIX

CIMZIA

CIVANEX

CLEVIPREX

CLOLAR

COLESEVELAM HYDROCHLORIDE (LODALIS)

CONSTELLA

COSENTYX

COTELLIC

COVERSYL

CUBICIN

CYMBALTA

CYRAMZA

D

DAKLINZA

DARZALEX

DAXAS

DEXILANT

DIACOMIT

DIFICID

DORIBAX

DUAVIVE

DUREZOL

DYMISTA

E

EDARBI

EDURANT

EFFIENT

EFRACEA

EGRIFTA

ELAPRASE

ELELYSO

ELIQUIS

ELOCTATE

ELOXATIN

EMEND

EMEND IV

EMTRIVA

ENABLEX

ENTRESTO

ENTYVIO

EPERZAN

ERAXIS

ERBITUX

ERIVEDGE

ESBRIET

EXELON PATCH

EXJADE

EYLEA

F

FAMPYRA

FERAHEME

FERRIPROX

FETZIMA

FIBRISTAL

FINACEA

FIRAZYR

FIRMAGON

FLUMIST

FORXIGA

FOSRENOL

FYCOMPA

G

GALEXOS

GARDASIL

GARDASIL 9

GAZYVA

GENVOYA

GILENYA

GIOTRIF

GRASTOFIL

H

HALAVEN

HARVONI

HOLKIRA PAK

I

IBRANCE

ICLUSIG

IDELVION

ILARIS

IMBRUVICA

INCIVEK

INFLECTRA

INFLUENZA A (H1N1) 2009 PANDEMIC MONOVALENT VACCINE (WITHOUT ADJUVANT)

INLYTA

INOMAX

INSPRA

INTELENCE

INTUNIV XR

INVEGA

INVEGA SUSTENNA

INVOKANA

ISENTRESS

ISTODAX

IXIARO

J

JAKAVI

JANUVIA

JARDIANCE

JETREA

JEVTANA

JUBLIA

JUXTAPID

K

KADCYLA

KALYDECO

KEPIVANCE

KEYTRUDA

KUVAN

KYPROLIS

L

LATUDA

LENVIMA

LEUKOSCAN

LEVEMIR

LODALIS

LUCENTIS

LUVERIS

LYNPARZA

LYRICA

M

MABCAMPATH

MACUGEN

MEKINIST

MENVEO

METVIX

MIFEGYMISO

MIRCERA

MOVANTIK

MOZOBIL

MULTAQ

MYCAMINE

MYOZYME

MYRBETRIQ

N

NAGLAZYME

NATRECOR

NESINA

NEUPRO

NEVANAC

NEXAVAR

NIMENRIX

NPLATE

NUCALA

NUCYNTA CR

NUWIQ

O

OBIZUR

OFEV

OLMETEC

OMNITROPE

ONBREZ BREEZHALER

ONGLYZA

OPDIVO

OPSUMIT

ORENCIA

ORKAMBI

OTEZLA

OXYNEO

P

PANTOLOC M

PERJETA

PHEBURANE

PICATO

PLEGRIDY

POMALYST

POSANOL

POTIGA

PRADAX

PRALUENT

PRAXBIND

PRECEDEX

PREVNAR 13

PREXIGE

PREZISTA

PRIMOVIST

PRISTIQ

PROCHYMAL

PROLENSA

PROLIA

R

RAPAFLO

RAPTIVA

RASILEZ

RAVICTI

RECOTHROM

RELISTOR

REMOVAB

REMSIMA

REPATHA

RESOTRAN

REVESTIVE

REVLIMID

REVOLADE

ROSIVER

ROTARIX

ROTATEQ

RUBY-FILL

S

SAFLUTAN

SAMSCA

SAPHRIS

SEBIVO

SIGNIFOR

SIMPONI

SIVEXTRO

SOLIRIS

SOMATULINE AUTOGEL

SOMAVERT

SOVALDI

SPRYCEL

STELARA

STIVARGA

STRENSIQ

STRIBILD

STRIVERDI RESPIMAT

SUNVEPRA

SUTENT

SWISH SILVER SUPREME

SYLVANT

SYNFLORIX

T

TAFINLAR

TALTZ

TASIGNA

TECFIDERA

THELIN

TIVICAY

TOCTINO

TORISEL

TOVIAZ

TRAJENTA

TRAMACET

TREANDA

TRETTEN

TRINTELLIX

TROSEC

TRULICITY

TUDORZA GENUAIR

TYKERB

TYGACIL

TYSABRI

U

UPTRAVI

ULORIC

V

VANTAS

VARITHENA

VASOVIST

VECTIBIX

VELCADE

VESICARE

VIBATIV

VICTOZA

VICTRELIS

VIDAZA

VIIBRYD

VIMIZIM

VIMPAT

VISANNE

VOLIBRIS

VOLTAREN

VOTRIENT

VPRIV

VYVANSE

X

XALKORI

XARELTO

XELJANZ

XIAFLEX

XOFIGO

XTANDI

XTORO

XYREM

Y

YERVOY

YONDELIS

Z

ZAXINE

ZEFTERA

ZELBORAF

ZELDOX

ZEMPLAR

ZEPATIER

ZERBAXA

ZEVALIN

ZOLINZA

ZONOVATE

ZONTIVITY

ZYDELIG

ZYKADIA

ZYTIGA