Factor VIII products and inhibitor development: Concepts for revision of European regulatory guidelines

Haemophilia

Volumn 14, Issue 1, 2008, Pages 142-144

  Neugebauer, Brigitte ^a   Drai, C ^a   Haase, M ^b   Hilger, A ^b   Keller Stanislawski, B ^b   Laitinen Parkkonen, P ^c   Mentzer, D ^b   Rasmussen, C ^d   Ratignier, C ^e   Seitz, R ^b  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b PAUL EHRLICH INSTITUT   (Germany)

^c NATIONAL AGENCY FOR MEDICINES   (Finland)

^d DANISH MEDICINES AGENCY   (Denmark)

^e AFSSAPS   (France)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 8 INHIBITOR; BLOOD CLOTTING FACTOR 9; NEUTRALIZING ANTIBODY; RECOMBINANT BLOOD CLOTTING FACTOR 8;

ANTIBODY PRODUCTION; ARTICLE; CONSENSUS DEVELOPMENT; DATA COLLECTION METHOD; DRUG SURVEILLANCE PROGRAM; EUROPE; HEMOPHILIA A; HUMAN; IMMUNOGENICITY; IMMUNOLOGICAL TOLERANCE; INTERNATIONAL COOPERATION; MEDICAL EXPERT; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REGISTER; RISK MANAGEMENT; STANDARDIZATION; WORKSHOP;

CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; FACTOR VIII; HUMANS; ISOANTIBODIES; PRACTICE GUIDELINES AS TOPIC;

EID: 37749029270     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2007.01604.x     Document Type: Article

References (5)

1. EMEA. Report of the Expert Meeting on Factor VIII Products and Inhibitor Development, 28 February 2006-2 March 2006. London: European Medicines Agency. Available at: http://www.emea.europa.eu/pdfs/human/bpwg/ 12383506en.pdf (last accessed 09.11.07).
2. Peerlinck K, Arnout J, Di Giambattista M et.al. Factor VIII inhibitors in previously treated haemophilia A patients with a double virus-inactivated plasma derived factor VIII concentrate. Thromb Haemost 1997; 77: 88.
3. EMEA Public Statement: Review of Recombinant Factor VIII (FVIII) Products and Inhibitor Development. London: European Medicines Agency. Available at: http://www.emea.europa.eu/pdfs/human/press/pus/ 33131605en.pdf (last accessed 09.11.07).
4. Développement des inhibiteurs et prise en charge chez les patients hémophiles traités par facteur VIII ou IX d'origine plasmatique ou recombinante. Saint-Denis Cedex: Agence Française de Sécurité. Available at: http://afssaps.sante.fr/pdf/5/dev-inhibiteur-hemophile-facteur8.pdf (last accessed 09.11.07).
5. EMEA Guideline on Risk Management Systems for Medicinal Products for Human Use. London: European MedicinHs Agency. Available at: http://www.emea.europa.eu/pdfs/human/euleg/9626805en.pdf (last accessed 09.11.07).