Skip to content | Skip to institutional links

Common menu bar links

Institutional links

Back to
- Summary Basis of Decision
Explore...
Transparency

Completed Access to Information Requests

Proactive Disclosure

Drugs and Health Products

Need Larger Text? |

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.

A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

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.

Phase I Reader's Guide to the SBD - Drugs [2005-06-29]

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

Phase II Reader's Guide to the SBD - Drugs [2012-06-29]

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 Food and Drugs Act and/or the 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.

Summary Basis of Decision Documents: Drugs

A

ABILIFY

Notice of Decision [2009-08-11]
Summary Basis of Decision [2009-11-26]

ACTEMRA

Notice of Decision [2010-05-25]
Summary Basis of Decision [2010-10-04]

ADCETRIS

Summary Basis of Decision [2013-04-03]

AFINITOR

Notice of Decision [2010-01-14]
Summary Basis of Decision [2010-06-07]

ALOXI

Notice of Decision [2012-04-03]
Summary Basis of Decision [2012-08-21]

ALREX

Notice of Decision [2009-01-27]
Summary Basis of Decision [2009-04-06]

ALTARGO

Notice of Decision [2008-06-17]
Summary Basis of Decision [2008-12-08]

ALVESCO

Notice of Decision [2006-10-24]
Summary Basis of Decision [2008-01-30]

APIDRA

Notice of Decision [2007-01-05]
Summary Basis of Decision [2007-07-12]

APTIVUS

Notice of Decision [2006-03-17]
Summary Basis of Decision [2006-08-15]

AREPANRIX^TM H1N1

Notice of Decision [2009-10-21]
Summary Basis of Decision [2010-05-11]

ARZERRA

Notice of Decision [2012-04-18]
Summary Basis of Decision [2012-11-02]

AREPANRIX H5N1

Summary Basis of Decision [2013-05-13]

ATRIANCE

Notice of Decision [2007-10-23]
Summary Basis of Decision [2008-05-12]

AVAMYS

Notice of Decision [2007-11-06]
Summary Basis of Decision [2008-01-30]

AVASTIN

Notice of Decision [2006-02-16]
Summary Basis of Decision [2006-05-11]

AZILECT

Notice of Decision [2007-03-16]
Summary Basis of Decision [2008-06-22]

B

BANZEL

Notice of Decision [2011-07-29]
Summary Basis of Decision [2011-10-12]

BARACLUDE

Notice of Decision [2006-08-08]
Summary Basis of Decision [2007-01-02]

BENLYSTA

Notice of Decision [2011-08-30]
Summary Basis of Decision [2011-12-15]

BERINERT

Notice of Decision [2010-07-06]
Summary Basis of Decision [2011-01-06]

BESIVANCE

Notice of Decision [2009-12-10]
Summary Basis of Decision [2010-04-09]

BEXXAR

Notice of Decision [2005-12-13]
Summary Basis of Decision [2006-11-08]

BRILINTA

Notice of Decision [2011-07-11]
Summary Basis of Decision [2011-11-29]

BYETTA

Notice of Decision [2011-02-17]
Summary Basis of Decision [2011-05-27]

BYSTOLIC

Post-Authorization Activity [2013-05-22]
Summary Basis of Decision [2013-02-22]

C

CAMPRAL

Notice of Decision [2007-04-23]
Summary Basis of Decision [2008-05-05]

CANTRACE

Notice of Decision [2006-12-13]
Summary Basis of Decision [2008-01-28]

CAPRELSA

Notice of Decision [2012-02-22]
Summary Basis of Decision [2012-06-19]

CATENA

Notice of Decision [2008-08-28]
Summary Basis of Decision [2009-03-06]

CAYSTON

Notice of Decision [2009-10-19]
Summary Basis of Decision [2010-07-29]

CELSENTRI

Notice of Decision [2008-01-03]
Summary Basis of Decision [2008-04-22]

CERVARIX

Notice of Decision [2010-09-02]
Summary Basis of Decision [2010-10-26]

CHAMPIX

Notice of Decision [2007-04-02]
Summary Basis of Decision [2008-01-31]

CIMZIA

Notice of Decision [2009-09-24]
Summary Basis of Decision [2010-03-11]

CIVANEX

Notice of Decision [2010-09-17]
Summary Basis of Decision [2010-11-11]

CLEVIPREX

Notice of Decision [2011-05-16]
Summary Basis of Decision [2011-07-11]

CLOLAR

Notice of Decision [2009-08-11]
Summary Basis of Decision [2009-11-25]

COLESEVELAM HYDROCHLORIDE (LODALIS)

Notice of Decision [2011-10-27]
Summary Basis of Decision [2012-01-27]

COVERSYL

Notice of Decision [2005-11-25]
Summary Basis of Decision [2006-03-10]

CUBICIN

Notice of Decision [2007-11-01]
Summary Basis of Decision [2008-07-31]

CYMBALTA

Notice of Decision [2008-03-17]
Summary Basis of Decision [2008-05-05]

D

DAXAS

Notice of Decision [2010-12-13]
Summary Basis of Decision [2011-03-08]

DEXILANT

Notice of Decision [2010-10-05]
Summary Basis of Decision [2010-11-29]

DIACOMIT

Summary Basis of Decision [2013-02-21]

DIFICID

Notice of Decision [2012-07-11]
Summary Basis of Decision [2012-10-30]

DORIBAX

Notice of Decision [2009-10-05]
Summary Basis of Decision [2010-01-07]

E

EDARBI

Notice of Decision [2012-04-16]
Summary Basis of Decision [2012-06-26]

EDURANT

Notice of Decision [2011-08-16]
Summary Basis of Decision [2011-11-25]

EFFIENT

Notice of Decision [2010-05-14]
Summary Basis of Decision [2010-07-13]

EFRACEA

Notice of Decision [2011-11-29]
Summary Basis of Decision [2012-02-28]

ELAPRASE

Notice of Decision [2007-10-09]
Summary Basis of Decision [2007-12-17]

ELIQUIS

Notice of Decision [2012-02-09]
Summary Basis of Decision [2012-04-26]

ELOXATIN

Notice of Decision [2007-09-12]
Summary Basis of Decision [2009-02-19]

EMEND

Notice of Decision [2007-09-25]
Summary Basis of Decision [2008-03-12]

EMEND IV

Notice of Decision [2009-05-25]
Summary Basis of Decision [2010-03-05]

EMTRIVA

Notice of Decision [2006-05-17]
Summary Basis of Decision [2006-07-05]

ENABLEX

Notice of Decision [2005-12-22]
Summary Basis of Decision [2006-03-31]

ERAXIS

Notice of Decision [2008-01-16]
Summary Basis of Decision [2008-04-16]

ERBITUX

Notice of Decision [2006-05-16]
Summary Basis of Decision [2007-01-11]

ESBRIET

Post-Authorization Activity [2013-05-06]
Summary Basis of Decision [2012-12-12]

EXELON PATCH

Notice of Decision [2008-02-21]
Summary Basis of Decision [2008-06-22]

EXJADE

Notice of Decision [2007-01-17]
Summary Basis of Decision [2007-11-27]

F

FAMPYRA

Notice of Decision [2012-03-19]
Summary Basis of Decision [2012-07-09]

FERAHEME

Notice of Decision [2012-02-01]
Summary Basis of Decision [2012-06-26]

FINACEA

Notice of Decision [2006-03-24]
Summary Basis of Decision [2006-03-24]

FIRMAGON

Notice of Decision [2009-12-11]
Summary Basis of Decision [2010-12-16]

FLUMIST

Notice of Decision [2010-08-26]
Summary Basis of Decision [2011-01-10]

FOSRENOL

Notice of Decision [2007-02-19]
Summary Basis of Decision [2007-11-05]

FYCOMPA

Summary Basis of Decision [2013-05-31]

G

GARDASIL

Notice of Decision [2006-10-23]
Summary Basis of Decision [2007-03-16]

GILENYA

Notice of Decision [2011-04-11]
Summary Basis of Decision [2011-11-09]

H

HALAVEN

Notice of Decision [2012-01-27]
Summary Basis of Decision [2012-04-26]

I

ILARIS

Notice of Decision [2010-04-09]
Summary Basis of Decision [2010-07-29]

INCIVEK

Notice of Decision [2011-09-22]
Summary Basis of Decision [2012-04-03]

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

Notice of Decision [2009-11-12]

INLYTA

Notice of Decision [2012-08-16]
Summary Basis of Decision [2012-11-06]

INOMAX

Notice of Decision [2005-11-28]
Summary Basis of Decision [2006-01-26]

INSPRA

Notice of Decision [2009-03-27]
Summary Basis of Decision [2009-07-22]

INTELENCE

Notice of Decision [2008-04-18]
Summary Basis of Decision [2008-12-22]

INVEGA

Notice of Decision [2008-03-17]
Summary Basis of Decision [2008-04-29]

INVEGA SUSTENNA

Notice of Decision [2010-10-04]
Summary Basis of Decision [2010-11-01]

ISENTRESS

Notice of Decision [2008-01-16]
Summary Basis of Decision [2008-08-07]

IXIARO

Notice of Decision [2009-12-02]
Summary Basis of Decision [2010-07-20]

J

JAKAVI

Notice of Decision [2012-07-16]
Summary Basis of Decision [2012-11-06]

JANUVIA

Notice of Decision [2008-02-05]
Summary Basis of Decision [2008-08-19]

JEVTANA

Notice of Decision [2011-07-04]
Summary Basis of Decision [2011-09-07]

K

KALYDECO

Post-Authorization Activity [2013-05-06]
Summary Basis of Decision [2012-12-24]

KEPIVANCE

Notice of Decision [2006-07-27]
Summary Basis of Decision [2007-02-14]

KUVAN

Notice of Decision [2010-06-02]
Summary Basis of Decision [2010-08-12]

L

LATUDA

Notice of Decision [2012-07-11]
Summary Basis of Decision [2012-10-15]

LEUKOSCAN

Notice of Decision [2006-06-23]
Summary Basis of Decision [2007-01-19]

LEVEMIR

Notice of Decision [2006-05-15]
Summary Basis of Decision [2006-08-09]

LODALIS

Notice of Decision [2011-11-22]
Summary Basis of Decision [2012-01-27]

LUCENTIS

Notice of Decision [2007-07-30]
Summary Basis of Decision [2007-12-21]

LUVERIS

Notice of Decision [2006-05-15]
Summary Basis of Decision [2007-01-19]

LYRICA

Notice of Decision [2005-08-04]
Summary Basis of Decision [2007-10-30]

M

MABCAMPATH

Notice of Decision [2006-08-11]
Summary Basis of Decision [2007-05-29]

MACUGEN

Notice of Decision [2005-06-02]
Summary Basis of Decision [2006-03-01]

MENVEO

Notice of Decision [2010-06-23]
Summary Basis of Decision [2010-10-29]

METVIX

Notice of Decision [2009-03-17]
Summary Basis of Decision [2009-07-17]

MIRCERA

Notice of Decision [2008-07-03]
Summary Basis of Decision [2009-01-19]

MOZOBIL

Notice of Decision [2012-02-06]
Summary Basis of Decision [2012-04-26]

MULTAQ

Notice of Decision [2009-09-17]
Summary Basis of Decision [2010-01-07]

MYCAMINE

Notice of Decision [2007-07-18]
Summary Basis of Decision [2008-01-10]

MYOZYME

Notice of Decision [2006-12-06]
Summary Basis of Decision [2007-07-30]

MYRBETRIQ

Summary Basis of Decision [2013-04-30]

N

NATRECOR

Notice of Decision [2008-05-14]
Summary Basis of Decision [2007-11-08]

NEVANAC

Notice of Decision [2008-07-07]
Summary Basis of Decision [2008-12-08]

NEXAVAR

Notice of Decision [2006-09-08]
Summary Basis of Decision [2007-05-25]

NIMENRIX

Summary Basis of Decision [2013-05-13]

NPLATE

Notice of Decision [2009-03-30]
Summary Basis of Decision for NPLATE [2009-07-21]

NUCYNTA CR

Notice of Decision [2011-01-24]
Summary Basis of Decision [2011-04-15]

O

OLMETEC

Notice of Decision [2008-12-23]
Summary Basis of Decision [2009-02-11]

OMNITROPE

Notice of Decision [2009-05-15]
Summary Basis of Decision [2009-09-14]

ONBREZ BREEZHALER

Notice of Decision [2012-01-13]
Summary Basis of Decision [2012-07-11]

ONGLYZA

Notice of Decision [2009-10-09]
Summary Basis of Decision [2010-06-10]

ORENCIA

Notice of Decision [2007-01-08]
Summary Basis of Decision [2007-05-07]

OXYNEO

Notice of Decision [2012-11-26]

P

PANTOLOC M

Notice of Decision [2006-01-04]
Summary Basis of Decision [2006-06-22]

PICATO

Post-Authorization Activity [2013-05-06]
Summary Basis of Decision [2013-03-11]

POSANOL

Notice of Decision [2008-08-07]
Summary Basis of Decision [2008-08-07]

POTIGA

Post-Authorization Activity [2013-05-06]
Summary Basis of Decision [2012-12-21]

PRADAX

Notice of Decision [2008-07-14]
Summary Basis of Decision [2008-12-23]

PRECEDEX

Notice of Decision [2010-01-14]
Summary Basis of Decision [2010-09-23]

PREVNAR 13

Notice of Decision [2010-01-30]
Summary Basis of Decision [2010-11-15]

PREXIGE

Notice of Decision [2007-01-30]
Summary Basis of Decision [2007-06-27]

PREZISTA

Notice of Decision [2006-10-03]
Summary Basis of Decision [2007-05-25]

PRIMOVIST

Notice of Decision [2010-02-15]
Summary Basis of Decision [2010-05-28]

PRISTIQ

Notice of Decision [2009-03-16]
Summary Basis of Decision [2009-05-29]

PROCHYMAL

Notice of Decision [2012-08-02]
Summary Basis of Decision [2012-10-05]

PROLIA

Notice of Decision [2010-10-14]
Summary Basis of Decision [2011-01-17]

R

RAPAFLO

Notice of Decision [2011-02-11]
Summary Basis of Decision [2011-05-12]

RAPTIVA

Notice of Decision [2006-08-02]
Summary Basis of Decision [2007-05-15]

RASILEZ

Notice of Decision [2007-12-13]
Summary Basis of Decision [2008-05-01]

RECOTHROM

Notice of Decision [2010-02-10]
Summary Basis of Decision [2010-08-30]

RELISTOR

Notice of Decision [2008-06-17]
Summary Basis of Decision [2008-12-11]

REMOVAB

Notice of Decision [2012-09-06]
Summary Basis of Decision [2012-12-20]

RESOTRAN

Notice of Decision [2012-01-13]
Summary Basis of Decision [2012-05-16]

REVLIMID

Notice of Decision [2008-03-27]
Summary Basis of Decision [2008-06-24]

REVOLADE

Notice of Decision [2011-02-23]
Summary Basis of Decision [2011-06-14]

ROTARIX

Notice of Decision [2008-01-04]
Summary Basis of Decision [2008-07-23]

ROTATEQ

Notice of Decision [2006-12-04]
Summary Basis of Decision [2007-06-04]

RUBY-FILL

Notice of Decision [2011-12-12]
Summary Basis of Decision [2012-01-23]

S

SAMSCA

Notice of Decision [2011-09-02]
Summary Basis of Decision [2011-12-08]

SAPHRIS

Notice of Decision [2011-12-02]
Summary Basis of Decision [2012-02-14]

SEBIVO

Notice of Decision [2007-02-12]
Summary Basis of Decision [2008-04-18]

SIMPONI

Notice of Decision [2009-05-21]
Summary Basis of Decision [2009-09-02]

SOLIRIS

Notice of Decision [2009-02-27]
Summary Basis of Decision [2009-07-22]

SOMATULINE AUTOGEL

Notice of Decision [2006-08-31]
Summary Basis of Decision [2007-03-16]

SOMAVERT

Notice of Decision [2006-06-07]
Summary Basis of Decision [2006-11-06]

SPRYCEL

Notice of Decision [2007-05-09]
Summary Basis of Decision [2007-08-07]

STELARA

Notice of Decision [2009-01-29]
Summary Basis of Decision [2009-05-27]

STIVARGA

Post-Authorization Activity [2013-06-03]
Summary Basis of Decision [2013-05-07]

STRIBILD

Post-Authorization Activity [2013-05-06]
Summary Basis of Decision [2013-02-04]

SUTENT

Notice of Decision [2006-07-28]
Summary Basis of Decision [2007-01-17]

SWISH SILVER SUPREME

Notice of Decision [2010-06-14]
Summary Basis of Decision [2010-12-13]

SYNFLORIX

Notice of Decision [2009-02-13]
Summary Basis of Decision [2009-06-16]

T

TARCEVA

Notice of Decision [2005-11-15]
Summary Basis of Decision [2006-01-11]

TASIGNA

Notice of Decision [2008-12-03]
Summary Basis of Decision [2009-05-04]

TECFIDERA

Summary Basis of Decision [2013-05-27]

THELIN

Notice of Decision [2007-06-21]
Summary Basis of Decision [2007-09-18]

TOCTINO

Notice of Decision [2009-12-16]
Summary Basis of Decision [2010-04-12]

TORISEL

Notice of Decision [2008-02-04]
Summary Basis of Decision [2009-01-06]

TOVIAZ

Notice of Decision [2012-03-11]
Summary Basis of Decision [2012-05-30]

TRAJENTA

Notice of Decision [2011-11-07]
Summary Basis of Decision [2011-12-23]

TRAMACET

Notice of Decision [2005-12-09]
Summary Basis Of Decision [2008-09-17]

TREANDA

Notice of Decision [2012-10-09]
Summary Basis Of Decision [2012-12-10]

TRETTEN

Notice of Decision [2012-07-30]
Summary Basis of Decision [2012-10-19]

TROSEC

Notice of Decision [2006-03-02]
Summary Basis of Decision [2006-07-31]

TYKERB

Notice of Decision [2009-06-12]
Summary Basis of Decision [2009-11-03]

TYGACIL

Notice of Decision [2006-10-27]
Summary Basis of Decision [2007-03-12]

TYSABRI

Notice of Decision [2007-04-19]
Summary Basis of Decision [2007-10-05]

U

ULORIC

Notice of Decision [2010-10-22]
Summary Basis of Decision [2010-12-21]

V

VANTAS

Notice of Decision [2006-07-31]
Summary Basis of Decision [2006-10-27]

VASOVIST

Notice of Decision [2007-01-16]
Summary Basis of Decision [2008-01-30]

VECTIBIX

Notice of Decision [2008-06-25]
Summary Basis of Decision [2008-12-18]

VELCADE

Notice of Decision [2005-06-08]
Summary Basis of Decision [2005-12-29]

VESICARE

Notice of Decision [2006-04-20]
Summary Basis of Decision [2006-07-27]

VIBATIV

Notice of Decision [2009-11-18]
Summary Basis of Decision [2010-02-10]

VICTOZA

Notice of Decision [2010-06-17]
Summary Basis of Decision [2010-10-26]

VICTRELIS

Notice of Decision [2011-09-13]
Summary Basis of Decision [2011-12-22]

VIDAZA

Notice of Decision [2009-12-07]
Summary Basis of Decision [2010-06-22]

VIMPAT

Notice of Decision [2010-11-16]
Summary Basis of Decision [2011-09-08]

VISANNE

Notice of Decision [2011-11-15]
Summary Basis of Decision [2012-02-14]

VOLIBRIS

Notice of Decision [2008-05-01]
Summary Basis of Decision [2008-07-31]

VOLTAREN

Notice of Decision [2008-07-08]
Summary Basis of Decision [2009-04-23]

VOTRIENT

Notice of Decision [2010-07-29]
Summary Basis of Decision [2010-12-07]

VPRIV

Notice of Decision [2010-11-12]
Summary Basis of Decision [2011-02-25]

VYVANSE

Notice of Decision [2009-05-29]
Summary Basis of Decision [2010-06-10]

X

XALKORI

Notice of Decision [2012-06-04]
Summary Basis of Decision [2012-07-26]

XARELTO

Notice of Decision [2009-01-12]
Summary Basis of Decision [2009-02-13]

XIAFLEX

Notice of Decision [2012-07-26]
Summary Basis of Decision [2012-10-05]

XYREM

Notice of Decision [2005-10-21]
Summary Basis of Decision [2006-03-22]

Y

YERVOY

Notice of Decision [2012-03-06]
Summary Basis of Decision [2012-07-06]

YONDELIS

Notice of Decision [2010-07-29]
Summary Basis of Decision [2010-09-23]

Z

ZEFTERA

Notice of Decision [2008-07-29]
Summary Basis of Decision [2009-08-14]

ZELBORAF

Notice of Decision [2012-03-11]
Summary Basis of Decision [2012-05-30]

ZELDOX

Notice of Decision [2008-02-13]
Summary Basis of Decision [2008-06-21]

ZEMPLAR

Notice of Decision [2005-06-03]
Summary Basis of Decision [2005-11-18]

ZEVALIN

Notice of Decision [2005-12-13]
Summary Basis of Decision [2006-06-23]

ZOLINZA

Notice of Decision [2009-07-17]
Summary Basis of Decision [2010-01-18]

ZYTIGA

Notice of Decision [2011-08-25]
Summary Basis of Decision [2012-02-21]