Differences in product information of biopharmaceuticals in the EU and the USA: Implications for product development

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 60, Issue 3, 2005, Pages 319-326

  Nieminen, Outi ^a   Kurki, Pekka ^b   Nordström, Katrina ^a  

^a AALTO UNIVERSITY   (Finland)

^b NATIONAL AGENCY FOR MEDICINES   (Finland)

Author keywords

Biopharmaceuticals; EMEA; FDA; Labelling; Marketing authorisation; Product information; Regulation

Indexed keywords

AGALSIDASE BETA; BASILIXIMAB; BECAPLERMIN; BETA1A INTERFERON; CONSENSUS INTERFERON; CORTICOSTEROID; CYCLOSPORIN; DACLIZUMAB; DISEASE MODIFYING ANTIRHEUMATIC DRUG; DROTRECOGIN; EXCIPIENT; HEPATITIS A HEPATITIS B VACCINE; HUMAN GROWTH HORMONE; IBRITUMOMAB TIUXETAN; IMIGLUCERASE; INFLIXIMAB; INSULIN ASPART; INSULIN GLARGINE; INSULIN LISPRO; INTERFERON BETA SERINE; METHOTREXATE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PACLITAXEL; PALIVIZUMAB; PEGINTERFERON ALPHA2A; PEGVISOMANT; PNEUMOCOCCUS VACCINE; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT BLOOD CLOTTING FACTOR 7A; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9; RECOMBINANT FOLLITROPIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RECOMBINANT THYROTROPIN; TRASTUZUMAB; UNINDEXED DRUG; VACCINE;

ARTICLE; CARDIOTOXICITY; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG PACKAGING; DRUG SAFETY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; LACTATION; LOW DRUG DOSE; NONHUMAN; PREGNANCY; PRESCRIPTION; UNITED STATES;

DRUG DESIGN; DRUG LABELING; EUROPE; GUIDELINES; PHARMACEUTICAL PREPARATIONS; UNITED STATES;

EID: 21544464575     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2005.01.013     Document Type: Article

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