Bivirkninger ved generisk bytte i Norge i 2005
- Publicerad: 04.12.2008
Referenser
1. van Manen RP, Fram D, DuMochel W. Signal detection methodologies to support effective safety management. Expert Opin Drug Saf 2007; 6: 451 – 64.
2. Forskrift om legemidler. Kap. 11. www.lovdata.no/for/sf/ho/xo-19991222-1559.html (24.8. 2007).
3. World Health Organization. The Uppsala Monitoring centre. Glossary of terms used in pharmacovigilance. www.who-umc.org/graphics/8321.pdf (16.8.2007).
4. Lov om apotek. Kap. 6. www.lovdata.no/all/hl-20000602-039.html (12.11.2008).
5. Statens legemiddelverk. Informasjon til pasienter. Hva er byttbare legemidler? www.legemiddelverket.no/upload/Dokumenter/Legemiddeløkonomi/forbruker_byttbare_legemidler.pdf (29.3.2008).
6. Committee for proprietary medicinal products (CPMP), The European agency for the evaluation of medicinal products (EMEA). Note for guidance on the investigation of bioavailability and bioequivalence. www.emea.europa.eu/pdfs/human/ewp/140198en.pdf (17.8.2007).
7. Statens legemiddelverk. Overvåkingsliste. www.legemiddelverket.no/upload/2008-09-15%20Legemidler%20under%20særlig%20overvåking.pdf (12.11.2008).
8. Halvorsen P. Generisk substitusjon – bitter pille for legene Tidsskr Nor Lægeforen 2000; 120: 1082 – 3.
9. Johannessen LB. Pass opp for generisk substitusjon! Tidsskr Nor Lægeforen 2001; 121: 1756.
10. Høie I. Skuffelse i legenes leir Tidsskr Nor Lægeforen 2001; 121: 737.
11. Statens legemiddelverk. Bivirkningsrapportering fra farmasøyter. www.legemiddelverket.no/templates/InterPage____16181.aspx?filterBy=CopyToConsumer (12.11.2008).
12. Edwards R, Lindquist M, Wiholm B-E et al. Quality criteria for early signals of possible adverse drug reactions. Lancet 1990; 336: 156 – 8.
13. Uppsala Monitoring Centre. The WHO adverse drug reactions database on-line searches user’s manual. 1997. www.who.int/medicines/areas/quality_safety/safety_efficacy/advdrugreactions/en/ (28.8.2008).
14. Lindquist M. Seeing and observing in international pharmacovigilance – achievements and prospects in worldwide drug safety. Doktoravhandling. Nijmegen: University of Nijmegen, 2003.
15. Gedde-Dahl A, Harg P, Stenberg-Nilsen H et al. Characteristics and quality of adverse drug reaction reports by pharmacists in Norway. Pharmacoepidemiol Drug Saf 2007; 16: 999 – 1005.
16. Rosner B. Fundamentals of biostatistics. Duxbury: Thomson Brooks/Cole, 2006: 441 – 5.
17. Statens legemiddelverk. Skjema for melding av bivirkninger ved bruk av legemidler (inkl. naturmidler). www.legemiddelverket.no/upload/2BOFA205bokmal.pdf (12.11.2008).
18. Läkemedelsverket. Biverkningsrapporter i samband med utbyte av läkemedel. www.lakemedelsverket.se/Tpl/NewsPage____1065.aspx (12.11.2008).
19. Legemiddelindustriforeningen. Tall og fakta 2006. www.lmi.no/tf/2006/files/norsk/tall_og_fakta_2006.pdf (26.8.2007).
20. Legemiddelindustriforeningen. Tall og fakta 2005. www.lmi.no/Tall_og_fakta_2005_v5_05GSFb2279v5.pdf.file (26.8.2007).
21. Statens legemiddelverk. Preparatomtale (SPC) Norvasc. www.legemiddelverket.no/spc/Godkjente/Norvasc-SPC.doc (29.3.2008).
22. Statens legemiddelverk. Preparatomtale (SPC) Amlodipin
Ratiopharm. www.legemiddelverket.no/spc/Godkjente/Amlodipin%20ratiopharm%205%2010%20mg%20SPC%20valid%20171103.doc (29.3.2008)
23. Verbeck RK, Kanfer I, Walker RB. Generic substitution: the use of medicinal products containing different salts and implications for safety and efficacy. Eur J Pharm Sci 2006; 28: 1 – 6.
24. Food and drug administration, FDA. Amlodipine citizen petition. www.fda.gov/ohrms/dockets/dailys/03/Sept03/090303/03p-0408-cp00001-08-Tab-G-vol3.pdf (10.2.2007).
25. Weiner M, Bernstein IL. Adverse reactions to drug formulation agents. A handbook of excipients. New York, NY: Marcel Dekker, 1989.
26. European medicines agency (EMEA). Notice to applicants. Nr. 3B. Guidelines for medicinal products for human use. Safety, environment and information. Excipients in the label and package leaflet of medicinal products for human use. www.emea.europa.eu/pdfs/human/productinfo/3bc7a_200307en.pdf (6.4.2008).
2. Forskrift om legemidler. Kap. 11. www.lovdata.no/for/sf/ho/xo-19991222-1559.html (24.8. 2007).
3. World Health Organization. The Uppsala Monitoring centre. Glossary of terms used in pharmacovigilance. www.who-umc.org/graphics/8321.pdf (16.8.2007).
4. Lov om apotek. Kap. 6. www.lovdata.no/all/hl-20000602-039.html (12.11.2008).
5. Statens legemiddelverk. Informasjon til pasienter. Hva er byttbare legemidler? www.legemiddelverket.no/upload/Dokumenter/Legemiddeløkonomi/forbruker_byttbare_legemidler.pdf (29.3.2008).
6. Committee for proprietary medicinal products (CPMP), The European agency for the evaluation of medicinal products (EMEA). Note for guidance on the investigation of bioavailability and bioequivalence. www.emea.europa.eu/pdfs/human/ewp/140198en.pdf (17.8.2007).
7. Statens legemiddelverk. Overvåkingsliste. www.legemiddelverket.no/upload/2008-09-15%20Legemidler%20under%20særlig%20overvåking.pdf (12.11.2008).
8. Halvorsen P. Generisk substitusjon – bitter pille for legene Tidsskr Nor Lægeforen 2000; 120: 1082 – 3.
9. Johannessen LB. Pass opp for generisk substitusjon! Tidsskr Nor Lægeforen 2001; 121: 1756.
10. Høie I. Skuffelse i legenes leir Tidsskr Nor Lægeforen 2001; 121: 737.
11. Statens legemiddelverk. Bivirkningsrapportering fra farmasøyter. www.legemiddelverket.no/templates/InterPage____16181.aspx?filterBy=CopyToConsumer (12.11.2008).
12. Edwards R, Lindquist M, Wiholm B-E et al. Quality criteria for early signals of possible adverse drug reactions. Lancet 1990; 336: 156 – 8.
13. Uppsala Monitoring Centre. The WHO adverse drug reactions database on-line searches user’s manual. 1997. www.who.int/medicines/areas/quality_safety/safety_efficacy/advdrugreactions/en/ (28.8.2008).
14. Lindquist M. Seeing and observing in international pharmacovigilance – achievements and prospects in worldwide drug safety. Doktoravhandling. Nijmegen: University of Nijmegen, 2003.
15. Gedde-Dahl A, Harg P, Stenberg-Nilsen H et al. Characteristics and quality of adverse drug reaction reports by pharmacists in Norway. Pharmacoepidemiol Drug Saf 2007; 16: 999 – 1005.
16. Rosner B. Fundamentals of biostatistics. Duxbury: Thomson Brooks/Cole, 2006: 441 – 5.
17. Statens legemiddelverk. Skjema for melding av bivirkninger ved bruk av legemidler (inkl. naturmidler). www.legemiddelverket.no/upload/2BOFA205bokmal.pdf (12.11.2008).
18. Läkemedelsverket. Biverkningsrapporter i samband med utbyte av läkemedel. www.lakemedelsverket.se/Tpl/NewsPage____1065.aspx (12.11.2008).
19. Legemiddelindustriforeningen. Tall og fakta 2006. www.lmi.no/tf/2006/files/norsk/tall_og_fakta_2006.pdf (26.8.2007).
20. Legemiddelindustriforeningen. Tall og fakta 2005. www.lmi.no/Tall_og_fakta_2005_v5_05GSFb2279v5.pdf.file (26.8.2007).
21. Statens legemiddelverk. Preparatomtale (SPC) Norvasc. www.legemiddelverket.no/spc/Godkjente/Norvasc-SPC.doc (29.3.2008).
22. Statens legemiddelverk. Preparatomtale (SPC) Amlodipin
Ratiopharm. www.legemiddelverket.no/spc/Godkjente/Amlodipin%20ratiopharm%205%2010%20mg%20SPC%20valid%20171103.doc (29.3.2008)
23. Verbeck RK, Kanfer I, Walker RB. Generic substitution: the use of medicinal products containing different salts and implications for safety and efficacy. Eur J Pharm Sci 2006; 28: 1 – 6.
24. Food and drug administration, FDA. Amlodipine citizen petition. www.fda.gov/ohrms/dockets/dailys/03/Sept03/090303/03p-0408-cp00001-08-Tab-G-vol3.pdf (10.2.2007).
25. Weiner M, Bernstein IL. Adverse reactions to drug formulation agents. A handbook of excipients. New York, NY: Marcel Dekker, 1989.
26. European medicines agency (EMEA). Notice to applicants. Nr. 3B. Guidelines for medicinal products for human use. Safety, environment and information. Excipients in the label and package leaflet of medicinal products for human use. www.emea.europa.eu/pdfs/human/productinfo/3bc7a_200307en.pdf (6.4.2008).