Translation of "Concentration du médicament à l'état stationnaire " (French → English) :

annul Commission Implementing Decision C(2014) 6030 final of 19 August 2014 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for high concentration of estradiol containing human medicinal products for topical use in so far as it requires Member States to comply with the obligations imposed in the implementing decision for the medicinal products listed in Annex I to the implementing decision and those not listed with 0,01 % estradiol by weight ...[+++] for topical use, with the exception of the restriction that the medicinal products named in Annex I to the implementing decision with 0,01 % estradiol by weight for topical use may be administered only intravaginally;

25. Welcomes the Commission's intention to propose a comprehensive Animal Health Law; calls on the Commission to adjust the scope and financing of European veterinary policy to take account of the specific characteristics of bees and beekeeping so that bee diseases can be combated more effectively via adequate availability of effective, standardised medicines in all Member States and financing of bee health in the framework of the European veterinary policy; calls on the Commission to ensure greater harmonisation among the Member States, focusing its efforts on combating and controlling varroasis in the EU;

Member States should consider how to use limited stocks due to limited current availability, and to prioritize those who should receive the drugs during the first wave, particularly focussing on those who are ill with the pandemic strain and, therefore, most likely benefit from early treatment.

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 ...

[Text] Question No. 26 Mr. John Cummins: 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 Ro ...[+++]che 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 since 1 ...

COUNCIL RESOLUTION DESIGNED TO IMPLEMENT THE OUTLINES OF AN INDUSTRIAL POLICY IN THE PHARMACEUTICAL SECTOR IN THE EUROPEAN UNION THE COUNCIL Having regard to the Commission communication of 14 September 1994 entitled "An industrial competitiveness policy for the European Union"; Recalling its Resolution of 21 November 1994 on strengthening the competitiveness of Community industry [10] , and its conclusions of 7 April 1995 on an industrial competitiveness policy; Having regard to the communication of 2 March 1994 from the Commission to the Council and the European Parliament ...[+++] on the outlines of an industrial policy for the pharmaceutical sector in the European Union; Whereas the European Union has an important role to play in creating a favourable environment for the expansion of activities relating to research, development, production and distribution of medicinal products and in encouraging the development of an innovative and effective European pharmaceutical industry in terms of competitiveness on the world market; Whereas European industrial policy must necessarily take account of the special nature of this sector, which relates both to public health and to social policy; whereas social security systems bear a considerable proportion of pharmaceutical expenditure; whereas this is a matter which falls within the competence of the Member States; Whereas the European Union has the responsibility of sketching out guidelines for the promotion of Community activities in this sector, HAS ADOPTED THIS RESOLUTION: I. WITH RESPECT TO THE SITUATION IN THE PHARMACEUTICAL INDUSTRY 1. recalls that the European pharmaceutical industry plays an essential role in public health, remains a high-technology industry with considerable added value, which is particularly successful, generates highly skilled jobs and makes a significant contribution to the Union's balance of trade; 2. considers that, now that it is facing increasingly intense international competition, the Euro ...