Safety-related regulatory actions for orphan drugs in the US and EU: A cohort study

Drug Safety

Volumn 33, Issue 2, 2010, Pages 127-137

  Heemstra, Harald E ^a   Giezen, Thijs J ^a,b   Mantel Teeuwisse, Aukje K ^a,b   De Vrueh, Remco L A ^c   Leufkens, Hubert G M ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c Steering Committee on Orphan Drugs   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

AGALSIDASE BETA; AMBRISENTAN; AMMONUL; BENZOIC ACID; BOSENTAN; CETUXIMAB; DEFERASIROX; GEMTUZUMAB OZOGAMICIN; IBRITUMOMAB TIUXETAN; ILOPROST; IMATINIB; LARONIDASE; MIGLUSTAT; ORPHAN DRUG; PHENYLACETIC ACID; SILDENAFIL; SITAXSENTAN; UNCLASSIFIED DRUG; ZOLEDRONIC ACID;

ANAPHYLAXIS; ARTICLE; BENIGN TUMOR; CARDIOPULMONARY ARREST; COHORT ANALYSIS; CONGESTIVE HEART FAILURE; CONNECTIVE TISSUE DISEASE; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; EUROPEAN UNION; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEART ATRIUM FIBRILLATION; HEART DISEASE; HEART FAILURE; HEART LEFT VENTRICLE FAILURE; HEPATOBILIARY DISEASE; HUMAN; HYPERSENSITIVITY REACTION; HYPOMAGNESEMIA; IMMUNOPATHOLOGY; INJECTION SITE REACTION; KIDNEY DISEASE; KIDNEY FAILURE; LIVER FAILURE; LIVER TOXICITY; LUNG TOXICITY; MALIGNANT NEOPLASTIC DISEASE; METABOLIC DISORDER; MUSCLE DISEASE; NUTRITIONAL DISORDER; PRIORITY JOURNAL; SKIN DISEASE; SKIN MANIFESTATION; UNITED STATES; URINARY TRACT DISEASE;

ADVERSE DRUG REACTION REPORTING SYSTEMS; COHORT STUDIES; DRUG APPROVAL; DRUG LABELING; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; ORPHAN DRUG PRODUCTION; UNITED STATES;

EID: 75649108603     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11319870-000000000-00000     Document Type: Article

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