Translation of "Information sur le médicament " (French → English) :

information on medicinal products

medicament [ medication ]

over-the-counter drug [ non-prescription drug | non-prescription medicinal product | OTC drug | OTC medicine | over-the-counter medicine ]

ethical drug | medicinal product subject to medical prescription | prescription drug | prescription medicine | prescription only medicine | prescription-only medicinal product | Rx drug | POM [Abbr.]

innovator brand | originator | originator brand | originator medicinal product | originator medicine | originator pharmaceutical | originator pharmaceutical product | originator product

European Medicines Agency [ EMA [acronym] European Agency for the Evaluation of Medicinal Products ]

Food and Drug Administration | United States Food and Drug Administration | US Food and Drug Administration | FDA [Abbr.] | US FDA [Abbr.]

National Prescription Drug Utilization Information System

package leaflet (1) | blurb (2) | package insert (3) | product information leaflet (4) | product information sheet (5)

Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the Licensing Requirements for Therapeutic Products | Therapeutic Products Licensing Requirements Ordinance [ TPLRO ]

Patients and healthcare professionals should be able to easily identify medicinal products that are subject to additional monitoring in order to allow them to share with the competent authorities and the marketing authorisation holder any information they have from the use of the medicinal product and in particular to report suspected adverse reactions.

implementation of a uniform e-prescribing system; publication of the complete price list for the medicines in the market; application of the list of non-reimbursed medicines and of the list of over-the-counter medicines; publication of the new list of reimbursed medicines using the new reference price system; the use of the information made available through e-prescribing and scanning for the collection of rebates from pharmaceutical companies; introduction of a monitoring mechanism allowing for pharmaceutical expenditure to be assessed on a monthly basis; enforcement of co-payments for regular outpatient services of EUR 5 and exte ...[+++]nsion of co-payments to unwarranted visits to emergency departments; publication of audited accounts for hospitals and health centres; and creation of an independent taskforce of health policy experts whose task is to produce, by end May 2011, a detailed report for an overall reform of the health system aimed at improving efficiency and effectiveness in the health system; ’;

The marketing authorisation holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorisation, and for ensuring that the product information is kept up to date.

factual, informative announcements (including announcements or statements such as those made to media organisations either in response to a direct enquiry or by making them available at conferences or by written releases and announcements or reports to shareholders and/or regulators) and reference material on a medicinal product, relating, for example, to its availability, packaging changes, adverse-reaction warnings as part of general drug precautions, trade catalogues, price lists, reimbursement and information on the environmental ...[+++]risk of the medicinal product and information relating to the disposal of unused medicinal products or waste derived from medicinal products as well as reference to any collection system in place, provided that such announcements and reference material include no promotional product claims and that they do not encourage or promote the consumption of the medicinal product ;