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$.. ‘r&L: 4A*+w~ Santi
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fIPP
13
’99
15:~2
FR
B DRUG SURUEILLRNCE
613
957
B335
%
Santi
Canada
tieal{h
‘ @
Canada
7X.45
P
RO
D
U
J
THERAPEUTIC
!“’
19+
+&~
OUR MISSION To ensure that the drugs, medicid devices
and other therapeutic products available in Canada are safe,
PRoDUCTS
PRO
“’
NOTREMISSION:
Faire ensortequeles m&dicamenrs, Ies
mat&ieIs mddicaux et les auues produits th&apeuti@es
disponibles au Canada soient sib, efficaces et de haute
qualit&
.’.‘,
TS
TH~RAPEUTIQUES
P
l?+rh~
——--?%JX:
~
DES
PRO GRAMME
b~
4A*+w~
?&zi:
&
P.01/20
TO 181861~4817
‘r&L:
GRAMMC
.
and of high quality.
effective
Visit our Website at / Visitez notre site Internet
www.hc-sc.gc.ca/hpb-dgps/therapeut
CONTINUING ASSESSMENT DIVISION / DIVISION DE LkVALUATION
CONTNUE
BUREAU OF DRUG SURVEILLANCE/
BUREAU DE LA SURVEILLANCE DES h@DICAMENTS
FINANCE BU~D~-G / EDIFICE FINANCE
FIRST FLOOR / ler ETAGE
OTTAWA (ONTARIO)
KIA 1B9
ADDRESS LOCATOR -020 lC 1- INDICE DE L’ADRESSE
FAX: (613) 957-0335
TO/A:
Robeti
.
Seidman
FAX:
1 (818)
,
NUMEEROF PAGES
NODE PAG=
712-6482
(81 8) 610-4817
TEL:
DATE:
April
13,
1999
TO FOLLOW 61
~ ~.
MESSAGWZWJ3SSAG33:
Dear
Mr.
Seidman,
This is further
information
on suspected
fexofenadine
cetirizine,
to your fax dated December
16, 1998 requesting
(ADRs ) associated
vich
adverse drug reactions
and loratadine.
We apologize
for the delay.
the
use
of
A search
of the national database was performed
for all the suspected
reactions
associated
with these suspected
drugs. The attached printouts
the results.
These
printouts
cover the time period
since
marketing
until
April
12,
1999.
There
may be reports
-*!aich have been received
by the program
Kindly
direct your attention of all
which are not yet entered into the database.
persons
using
these printouts
to the’ following
Caveat:
of reports on which this summary is based are
CAWZAT : The vast major~ty
Each report
laypersons.
submitted
by health
practitioners
ard to a les6er extent
opinion or obse~ation
of the individual reporter.
represents
the
suspicion,
Cause
and effect relationships
have ‘not been established
in the vasb majori~y of
information ’contained in these reporhs” to the Health
The
submitted.
reports
and has noc been sc%enti.f%cally or otherwise
Protection
Branch is raw information
verified
as to cause and effect relationship
by Health Protection
Branch
adverse
outline
scientists.
are
reported
Only a small proportion
OE suspected
adver6e reactions
to estimate
the
to the program,
consequently
this information
must not be used
of
adverse
reactions.
Repores subticced by phamceutical
incidence
manufacturers
are included in this summary.
This summary contains unpublished
will
be used
data
and is provided
to you with
the; understanding
that &his data
only within your %mxaediace organization.
If you have
any
further
questions,
please
do not
hesitate
i
??ascale
RECEIVED
TItlE
QPR.
13.
12:Q2Prl
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to
contacc
me.
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