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Volumn 69, Issue 2, 2007, Pages 165-172

Importance of package insert information in the European union: Medicinal and pharmaceutical experts questioning results

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG INDUSTRY; DRUG INFORMATION; DRUG SAFETY; EUROPEAN UNION; HUMAN; MEDICAL INFORMATION; MEDICAL PRACTICE; PHARMACEUTICAL CARE;

EID: 34247176387     PISSN: 0031711X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (25)

References (27)
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    • Council of the European Communities, Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. OJ 1992;L 113:107.
    • Council of the European Communities, Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. OJ 1992;L 113:107.
  • 5
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    • EMEA, QRD Working Group, Guidance of implementation, MR/DC/Referral Procedures Version 1.1 June 2006, 10 August 2006
    • EMEA, QRD Working Group - Guidance of implementation, MR/DC/Referral Procedures Version 1.1 (June 2006) http://www.emea.eu.int/htms/human/qrd/ qrdtemplate.htm, 10 August 2006.
  • 8
    • 34247096706 scopus 로고    scopus 로고
    • European Parliament and Council of the European Union, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ 2001;L 311:67.
    • European Parliament and Council of the European Union, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ 2001;L 311:67.
  • 9
    • 34247142116 scopus 로고    scopus 로고
    • European Parliament and Council of the European Union, Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 on the Community code relating to medicinal products for human use. OJ 2004;L136:34.
    • European Parliament and Council of the European Union, Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 on the Community code relating to medicinal products for human use. OJ 2004;L136:34.
  • 12
    • 34247155471 scopus 로고    scopus 로고
    • EFPIA Draft document, Status of implementation of the European Union pharmaceutical legislation at member state level, Date: 20 September 2006. Circular No 11.975 (2006).
    • EFPIA Draft document, Status of implementation of the European Union pharmaceutical legislation at member state level, Date: 20 September 2006. Circular No 11.975 (2006).
  • 14
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    • Gestaltung von Packungsbeilagen für Arzneimittel
    • Fuchs J, Hippius M, Schaefer M. Gestaltung von Packungsbeilagen für Arzneimittel. Pharm Ind. 2003; 65:302.
    • (2003) Pharm Ind , vol.65 , pp. 302
    • Fuchs, J.1    Hippius, M.2    Schaefer, M.3
  • 15
    • 0031495499 scopus 로고    scopus 로고
    • What do patients want to know about their medicines and what do doctors want to tell them? A comparative study
    • Berry DC, Michas IC, Gillie T. Forster M. What do patients want to know about their medicines and what do doctors want to tell them? A comparative study. Psychology and Health 1997;12:467.
    • (1997) Psychology and Health , vol.12 , pp. 467
    • Berry, D.C.1    Michas, I.C.2    Gillie, T.3    Forster, M.4
  • 17
    • 0033848472 scopus 로고    scopus 로고
    • Comprehensibility of the package leaflets of all medicinal products for human use: A questionnaire survey about the use of symbols and pictograms
    • Bernardini C, Ambrogie V, Perioli L et al. Comprehensibility of the package leaflets of all medicinal products for human use: a questionnaire survey about the use of symbols and pictograms. Pharmacological Research 2000;41:679.
    • (2000) Pharmacological Research , vol.41 , pp. 679
    • Bernardini, C.1    Ambrogie, V.2    Perioli, L.3
  • 18
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    • Influence of the drug package information paper on compliance of neurological and psychiatric outpatients
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    • (2002) Fortschr Neurol Psychiatr , vol.4 , pp. 178
    • Weitbrecht, W.-U.1    Voßkämper, C.2
  • 19
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    • dissertation, Humboldt University, Berlin
    • Fuchs J. Die Packungsbeilagen als ein Mittel zur gezielten Information und Handlungsanleitung für Patienten - Entwicklung und Testung eines Instrumentes zur Beurteilung und Optimierung der Packungsbeilagen von Arzneimitteln (Package inserts as medium to convey targeted information and directions for use to patients: Developing and testing a tool to rate and optimize pharmaceutical product package inserts), dissertation, Humboldt University, Berlin (2005).
    • (2005) Packungsbeilagen als ein Mittel zur gezielten Information und Handlungsanleitung für Patienten.
    • Die, F.J.1
  • 20
    • 34247093485 scopus 로고    scopus 로고
    • Fuchs J. Entwicklung und Testung eines Instrumentes zur Beurteilung und Optimierung von Packungsbeilagen. http://www.bfarm.de/nn_599148/SharedDocs/ Publikationen/DE/BfArM/publ/praesent/vortraege/dialog-060215/vortrag_fuc hs, templateId=raw,property=publication File.pdf/vortrag_fuchs.pdf, 7 July 2006.
    • Fuchs J. Entwicklung und Testung eines Instrumentes zur Beurteilung und Optimierung von Packungsbeilagen. http://www.bfarm.de/nn_599148/SharedDocs/ Publikationen/DE/BfArM/publ/praesent/vortraege/dialog-060215/vortrag_fuchs, templateId=raw,property=publication File.pdf/vortrag_fuchs.pdf, 7 July 2006.
  • 21
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    • Bernadini, C.1    Ambrogi, V.2    Fardella, G.3    Perioli, L.4    Grandolini, G.5
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    • Bundesinstitut für Arzneimittel und Medizinprodukte, Bekanntmachung über die Neufassung der Empfehlungen zur Gestaltung von Pakkungsbeilagen nach § 11 des Arzneimittelgesetzes (AMG) für Humanarzneimittel, 15. März 2002. BAnz. 2002;78:9083.
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    • Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz) in der Fassung der Neubekanntmachung, 11. Dezember 1998. BGBl. I 3586 (1998) (German drug law as of 11 December 1998).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.