Rosiglitazone: A European regulatory perspective

Diabetologia

Volumn 54, Issue 2, 2011, Pages 213-218

  Blind, E ^a   Dunder, K ^b   De Graeff, P A ^c,d   Abadie, E ^e  

^a UNIVERSITY OF WÜRZBURG   (Germany)

^b MEDICAL PRODUCTS AGENCY   (Sweden)

^c MEDICINES EVALUATION BOARD   (Netherlands)

^d UNIVERSITY OF GRONINGEN   (Netherlands)

^e AFSSAPS   (France)

Author keywords

Cardiovascular outcome studies; Cardiovascular risk; Diabetes mellitus; Drug safety; European Medicines Agency; Pioglitazone; RECORD trial; Regulatory approval; Rosiglitazone; Thiazolidinedione

Indexed keywords

GLIMEPIRIDE PLUS ROSIGLITAZONE; GLITAZONE DERIVATIVE; HEMOGLOBIN A1C; INSULIN; METFORMIN; METFORMIN PLUS ROSIGLITAZONE; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SULFONYLUREA;

CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CONGESTIVE HEART FAILURE; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG CONTROL; DRUG EFFICACY; DRUG INDICATION; DRUG LABELING; DRUG MECHANISM; DRUG RECALL; DRUG SAFETY; EUROPEAN UNION; EVIDENCE BASED MEDICINE; FLUID RETENTION; FOOD AND DRUG ADMINISTRATION; GLYCEMIC CONTROL; HEART DEATH; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HEMOGLOBIN BLOOD LEVEL; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; RISK REDUCTION; SIDE EFFECT;

CARDIOVASCULAR SYSTEM; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS; HUMANS; HYPOGLYCEMIC AGENTS; THIAZOLIDINEDIONES;

EID: 79151476743     PISSN: 0012186X     EISSN: 14320428     Source Type: Journal    
DOI: 10.1007/s00125-010-1992-5     Document Type: Review

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