Literature DB >> 15264349

[Drugs under temporary use authorisation: 50 years of French drug development].

Quiterie de Launet1, Agnès Brouard, Christian Doreau.   

Abstract

Drug under temporary use authorisation (authorisation temporaire d' utilisation - ATU) was created in 1994 in France. Before this date, various procedures controlled patients' use of imported drug and drug in process. The AIDS pandemy development in 80's and the need to control news drugs patients' use contributed to the ATU statement setting up. This regulatory statement allows companies to sell drugs without market drug authorisation (autorisation de mise sur le marché - AMM), the letter being done in adequation with good pharmaceutical quality and a satisfactory level of benefices/ risks ratio. It's a recent French drug evaluation evolution.

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Year:  2004        PMID: 15264349     DOI: 10.3406/pharm.2004.5596

Source DB:  PubMed          Journal:  Rev Hist Pharm (Paris)        ISSN: 0035-2349


  3 in total

1.  Temporary authorization for use: does the French patient access programme for unlicensed medicines impact market access after formal licensing?

Authors:  Albane Degrassat-Théas; Pascal Paubel; Olivier Parent de Curzon; Claude Le Pen; Martine Sinègre
Journal:  Pharmacoeconomics       Date:  2013-04       Impact factor: 4.981

Review 2.  Assessing the Value of Nusinersen for Spinal Muscular Atrophy: A Comparative Analysis of Reimbursement Submission and Appraisal in European Countries.

Authors:  Alessandra Blonda; Teresa Barcina Lacosta; Mondher Toumi; Steven Simoens
Journal:  Front Pharmacol       Date:  2022-01-21       Impact factor: 5.810

3.  Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme.

Authors:  Camille Taillé; Pascal Chanez; Gilles Devouassoux; Alain Didier; Christophe Pison; Gilles Garcia; Jeremy Charriot; Stéphane Bouée; Alina Gruber; Celine Pribil; Arnaud Bourdin; Marc Humbert
Journal:  Eur Respir J       Date:  2020-06-25       Impact factor: 16.671

  3 in total

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