Orphan medicinal products: Assessment after 5 years of European legislation;Médicaments orphelins: Bilan de 5 ans de législation Européenne

Medecine/Sciences

Volumn 22, Issue 1, 2006, Pages 71-74

  Borensztein, Pascale ^a  

^a GIS   (France)

Author keywords

[No Author keywords available]

Indexed keywords

AGALSIDASE ALFA; AGALSIDASE BETA; ANAGRELIDE; ARSENIC TRIOXIDE; BOSENTAN; BUSULFAN; CARGLUMIC ACID; CELECOXIB; CLADRIBINE; IBUPROFEN; ILOPROST; IMATINIB; LARONIDASE; LITAK; MIGLUSTAT; MITOTANE; NITISINONE; OMEGA CONOTOXIN MVIIA; ORPHAN DRUG; OXYBATE SODIUM; PEGVISOMANT; PHOTOFRIN; SILDENAFIL; UNCLASSIFIED DRUG; WILZIN; ZINC ACETATE;

ACROMEGALY; ADENOMATOUS POLYP; CATAPLEXY; CHRONIC PAIN; CYSTIC FIBROSIS; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; EUROPE; FABRY DISEASE; GASTROINTESTINAL STROMAL TUMOR; GAUCHER DISEASE; GLIOMA; HUMAN; HURLER SYNDROME; HYPERAMMONEMIA; IMMUNOPATHOLOGY; INFECTION; LEUKEMIA; LYMPHOMA; METABOLIC DISORDER; NEUROLOGIC DISEASE; NEUROMUSCULAR DISEASE; PULMONARY HYPERTENSION; REVIEW; THROMBOCYTHEMIA; TYROSINEMIA; WILSON DISEASE;

EID: 31144439780     PISSN: 07670974     EISSN: None     Source Type: Journal    
DOI: 10.1051/medsci/200622171     Document Type: Review

References (6)

1. Regulation (EC) n° 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. Official Journal of the European Communities 22 janvier 2000.
2. The orphan drug act. US Food and Drug Administration. www.fda.gov/orphan/oda.htm
3. Haffner ME, Whitley J, Moses M. Two decades of orphan product development. Nat Rev Drug Discov 2002; 1: 821-5.
4. COMP report to the commission in relation to article 10 of regulation 141/2000 an orphan medicinal products. http://www.emeaeu.int/index/indexhl.htm
5. Rinaldi A. Adopting an Orphan. EMBO Rep 2005; 6: 507-10.
6. Héron E. Les médicaments orphelins en Europe. Med Sci (Paris) 2005; 21 (n° spécial): 66-8.