Evaluation of post-authorization safety studies in the first cohort of eu risk management plans at time of regulatory approval

Drug Safety

Volumn 32, Issue 12, 2009, Pages 1175-1187

  Giezen, Thijs J ^a,b   Mantel Teeuwisse, Aukje K ^a,b   Straus, Sabine M J M ^a   Egberts, Toine C G ^b,c   Blackburn, Stella ^d   Persson, Ingemar ^d,e,f   Leufkens, Hubert G M ^a,b,d  

^a MEDICINES EVALUATION BOARD   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^d EUROPEAN MEDICINES AGENCY   (United Kingdom)

^e MEDICAL PRODUCTS AGENCY   (Sweden)

^f KAROLINSKA INSTITUTE   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; DASATINIB; ENTECAVIR; IDURONATE 2 SULFATASE; MELATONIN; METFORMIN PLUS PIOGLITAZONE; NATALIZUMAB; PALIPERIDONE; RANIBIZUMAB; RECOMBINANT ANTITHROMBIN III; RECOMBINANT GLUCAN 1,4 ALPHA GLUCOSIDASE; RECOMBINANT PARATHYROID HORMONE; RIMONABANT; SITAGLIPTIN; TIGECYCLINE; VARENICLINE; WART VIRUS VACCINE;

ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DATA BASE; DESCRIPTIVE RESEARCH; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; EVALUATION; HEALTH CARE SYSTEM; HUMAN; MEDICAL INFORMATION; METHODOLOGY; MOLECULE; POST AUTHORIZATION SAFETY STUDY; PRIORITY JOURNAL; REGISTER; RISK FACTOR; RISK MANAGEMENT;

BIOLOGICAL PRODUCTS; COHORT STUDIES; DRUG APPROVAL; DRUG TOXICITY; EUROPEAN UNION; HUMANS; RESEARCH DESIGN; RISK MANAGEMENT;

EID: 70449709036     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11318980-000000000-00000     Document Type: Article

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