Determinants for successful marketing authorisation of orphan medicinal products in the EU

Drug Discovery Today

Volumn 17, Issue 7-8, 2012, Pages 352-358

  Putzeist, Michelle ^a,b   Heemstra, Harald E ^a,b   Garcia, Jordi Llinares ^c   Mantel Teeuwisse, Aukje K ^a   Gispen De Wied, Christine C ^b   Hoes, Arno W ^b,d   Leufkens, Hubert G M ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c EUROPEAN MEDICINES AGENCY   (United Kingdom)

^d UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ORPHAN DRUG;

DRUG APPROVAL; DRUG INFORMATION; DRUG LEGISLATION; DRUG MARKETING; DRUG RESEARCH; EUROPEAN UNION; REVIEW; RISK BENEFIT ANALYSIS;

DRUG APPROVAL; DRUG INDUSTRY; EUROPE; HUMANS; MARKETING; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT;

EID: 84859266035     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2011.10.027     Document Type: Review

References (31)

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