Traduction de «Étude de contrôle de l'innocuité du Lariam » (Français → Anglais) :

Lariam Safety Monitoring Study [ Lariam (Mefloquine) Safety Monitoring Program ]

With regard to the purchase of mefloquine from the manufacturer and the oversight of mefloquine by the Health Protection Branch as mandated by the Food and Drug Act: (a) did the Canadian Forces indicate to the manufacturer on the order form when ordering mefloquine for Somalia that it was for use under the Food and Drug Act's Lariam Safety Monitoring Study; when was the order submitted; and when was the shipment received; (b) was the Health Protection Branch informed by the manufacturer that the Canadian Forces had indicated on the order form that the mefloquine was being ordered under the authority of the Lariam Safety Monitoring Stu ...[+++]dy and that this mefloquine was apparently purchased for the Somalia deployment; and when was the Health Protection Branch so informed; (c) did the Health Protection Branch receive from the manufacturer a request to fast track licensing approval for mefloquine (Lariam), and was licensing approval granted prior to the end of the Canadian Forces deployment in Somalia; (d) what was the date the Health Protection Branch received the final results of the Lariam Safety Monitoring Study from the manufacturer, and the date of the receipt by the Health Protection Branch of the last submission of the Safety Monitoring Study's results prior to licensing approval; (e) did the Department of National Defence prepare an advisory note acknowledging that evidence provided to the Somalia Inquiry had mislead the Inquiry as to the status of mefloquine approvals for the mefloquine used in the Somalia deployment; was the advisory note forwarded to the Minister of National Defence; and what action was taken when the Minister was so informed?

The dossier of the safety and efficacy studies shall include an introduction defining the subject and indicating the tests which have been carried out in compliance with Parts 3 and 4 as well as a summary, with detailed references to the published literature.

They should, in particular, set out the scientific data to be submitted for the identification and the characterisation of the additive concerned and the studies to be submitted to demonstrate its efficacy and its safety for humans, animals and the environment in view of the verification and assessment of the applications for authorisation by the European Food Safety Authority (the Authority).

Q-26 — Mr. Cummins (Delta—South Richmond) — With regard to the risk management of the antimalarial drug mefloquine by Health Canada and the Department of National Defence: (a) what deployments since 1990 involved administration of the drug to members of the Canadian Forces; (b) did Health Canada receive from the Canadian Forces adverse drug event reports for each such deployment either during or immediately following deployment; (c) how many Canadians received the drug under Health Canada’s Lariam Safety Monitoring Study; (d) how many patients were the subject of monitoring reports received by Health Canada directly or indirectly from ...[+++] Roche under the Lariam Safety Monitoring Study; (e) what types of adverse events were identified by the Lariam Safety Monitoring Study up to the time the drug was licensed in 1993; (f) what is the total number of adverse events reported to Health Canada since the commencement of marketing in 1993; (g) how many adverse events were reported to Health Canada since the commencement of the marketing of the drug in 1993 involving each of the following reactions - hallucinations, panic reaction, hyper alertness, extreme excitability, convulsions, aggressive reaction, marked restlessness, suicide, suicidal tendency, suicide attempt, thoughts of self harm, abnormal dreams, emotional disorder, irritability, nightmares, abnormal thinking, anxiety, depressed state, aggravated depression, light-headedness, anxiety attack, mood swings, abnormal crying, psychosis, delusion, speech disorder, concentration impaired, fear, euphoria, hysteria, paranoid psychosis, memory impairment, emotional disorder, murder; (h) what measures have been taken by Health Canada to ensure that it receives notice of such adverse drug events from doctors administering the drug; (i) what changes to the product monograph have been approved by Health Canada since licensing of the drug in 1993; (j) how many Canadian Forces members deployed on special missions abroad sinc ...