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$.. ‘r&L: 4A*+w~ Santi
~. $.. 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. 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