Risk minimization activities of centrally authorized products in the EU: A descriptive study

Drug Safety

Volumn 35, Issue 4, 2012, Pages 299-314

  Zomerdijk, Inge M ^a,b   Sayed Tabatabaei, Fakhredin A ^b   Trifir, Gianluca ^a,c   Blackburn, Stella C F ^d   Sturkenboom, Miriam C J M ^a   Straus, Sabine M J M ^a,b  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c UNIVERSITY OF MESSINA   (Italy)

^d EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

European Medicines Agency; Pharmacovigilance; Regulatory process; Risk management

Indexed keywords

ANTIHYPERTENSIVE AGENT; ANTINEOPLASTIC AGENT; BLOOD DERIVATIVE; HERBACEOUS AGENT; IMMUNOMODULATING AGENT; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; VACCINE;

ADVERSE OUTCOME; ARTICLE; DRUG LEGISLATION; DRUG SAFETY; EUROPE; POLICY; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; RISK REDUCTION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG APPROVAL; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; PATIENT EDUCATION AS TOPIC; PHARMACEUTICAL PREPARATIONS; PHARMACOVIGILANCE; RISK MANAGEMENT;

EID: 84858761668     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11594560-000000000-00000     Document Type: Article

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