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Volumn 48, Issue 10, 2009, Pages 625-633

Bioequivalence criteria for transdermal fentanyl generics: Do these need a relook?

Author keywords

[No Author keywords available]

Indexed keywords

CITALOPRAM; DIAZEPAM; DIPHENHYDRAMINE; ESPARMA; FENTADOLON; FENTANYL; HEUMANN; KREWEL; MORPHINE; MU OPIATE RECEPTOR AGONIST; NALOXONE; NORDAZEPAM; OXYCODONE; PARACETAMOL; PROMETHAZINE; RATIOPHARM; SANDOZ; TEMAZEPAM; UNCLASSIFIED DRUG;

EID: 70349145732     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11317200-000000000-00000     Document Type: Note
Times cited : (11)

References (53)
  • 1
    • 33645231857 scopus 로고    scopus 로고
    • Survey of chronic pain in Europe: Prevalence, impact on daily life, and treatment
    • Breivik H, Collett B, Ventafridda V, et al. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain 2006; 10 (4): 287-333
    • (2006) Eur J Pain , vol.10 , Issue.4 , pp. 287-333
    • Breivik, H.1    Collett, B.2    Ventafridda, V.3
  • 2
    • 0036792226 scopus 로고    scopus 로고
    • Does the A118G polymorphism at the mu-opioid receptor gene protect against morphine-6-glucuronide toxicity?
    • Lötsch J, Zimmermann M, Darimont J, et al. Does the A118G polymorphism at the mu-opioid receptor gene protect against morphine-6- glucuronide toxicity? Anesthesiology 2002; 97 (4): 814-819
    • (2002) Anesthesiology , vol.97 , Issue.4 , pp. 814-819
    • Lötsch, J.1    Zimmermann, M.2    Darimont, J.3
  • 3
    • 4344662491 scopus 로고    scopus 로고
    • Respiratory and haemodynamic effects of acute postoperative pain management: Evidence from published data
    • Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth 2004; 93 (2): 212-223
    • (2004) Br J Anaesth , vol.93 , Issue.2 , pp. 212-223
    • Cashman, J.N.1    Dolin, S.J.2
  • 4
    • 0022150431 scopus 로고
    • Postoperative analgesia following thoracotomy.Danger of delayed respiratory depression
    • Brown DL. Postoperative analgesia following thoracotomy.Danger of delayed respiratory depression. Chest 1985; 88 (5): 779-780
    • (1985) Chest , vol.88 , Issue.5 , pp. 779-780
    • Brown, D.L.1
  • 5
    • 0027202289 scopus 로고
    • Death from a morphine infusion during a sickle cell crisis
    • Gerber N, Apseloff G. Death from a morphine infusion during a sickle cell crisis. J Pediatr 1993; 123 (2): 322-325
    • (1993) J Pediatr , vol.123 , Issue.2 , pp. 322-325
    • Gerber, N.1    Apseloff, G.2
  • 6
    • 0027949272 scopus 로고
    • Adult respiratory distress syndrome associated with epidural fentanyl infusion
    • Goetz AM, Rogers PL, Schlichtig R, et al. Adult respiratory distress syndrome associated with epidural fentanyl infusion. Crit Care Med 1994; 22 (10): 1579-1583
    • (1994) Crit Care Med , vol.22 , Issue.10 , pp. 1579-1583
    • Goetz, A.M.1    Rogers, P.L.2    Schlichtig, R.3
  • 7
    • 0031800452 scopus 로고    scopus 로고
    • Respiratory depression following administration of intrathecal bupivacaine to an opioid-dependent patient.
    • Piquet CY, Mallaret MP, Lemoigne AH, et al. Respiratory depression following administration of intrathecal bupivacaine to an opioid-dependent patient. Ann Pharmacother 1998; 32 (6): 653-655
    • (1998) Ann Pharmacother , vol.32 , Issue.6 , pp. 653-655
    • Piquet, C.Y.1    Mallaret, M.P.2    Lemoigne, A.H.3
  • 8
    • 14844307854 scopus 로고    scopus 로고
    • Narcotic administration and stenosing lesions of the upper airway - A potentially lethal combination
    • Byard RW, Gilbert JD. Narcotic administration and stenosing lesions of the upper airway - a potentially lethal combination. J Clin Forensic Med 2005; 12 (1): 29-31
    • (2005) J Clin Forensic Med , vol.12 , Issue.1 , pp. 29-31
    • Byard, R.W.1    Gilbert, J.D.2
  • 9
    • 0020306547 scopus 로고
    • Death in the dental chair: Three drug fatalities in dental patients
    • Garriott JC, Di Maio VJ. Death in the dental chair: three drug fatalities in dental patients. J Toxicol Clin Toxicol 1982; 19 (9): 987-995
    • (1982) J Toxicol Clin Toxicol , vol.19 , Issue.9 , pp. 987-995
    • Garriott, J.C.1    Di Maio, V.J.2
  • 10
    • 33750283692 scopus 로고    scopus 로고
    • Fatal respiratory depression after multiple intravenous morphine injections
    • Lötsch J, Dudziak R, Freynhagen R, et al. Fatal respiratory depression after multiple intravenous morphine injections. Clin Pharmacokinet 2006; 45 (11): 1051-1060
    • (2006) Clin Pharmacokinet , vol.45 , Issue.11 , pp. 1051-1060
    • Lötsch, J.1    Dudziak, R.2    Freynhagen, R.3
  • 11
    • 2642540160 scopus 로고    scopus 로고
    • Activity of opioid ligands in cells expressing cloned mu opioid receptors
    • Gharagozlou P, Demirci H, David Clark J, et al. Activity of opioid ligands in cells expressing cloned mu opioid receptors. BMC Pharmacol 2003; 3 (1): 1-8
    • (2003) BMC Pharmacol , vol.3 , Issue.1 , pp. 1-8
    • Gharagozlou, P.1    Demirci, H.2    David Clark, J.3
  • 12
    • 0030014612 scopus 로고    scopus 로고
    • Direct conversion from oral morphine to transdermal fentanyl: A multicenter study in patients with cancer pain
    • Donner B, Zenz M, Tryba M, et al. Direct conversion from oral morphine to transdermal fentanyl: a multicenter study in patients with cancer pain. Pain 1996; 64 (3): 527-534
    • (1996) Pain , vol.64 , Issue.3 , pp. 527-534
    • Donner, B.1    Zenz, M.2    Tryba, M.3
  • 13
    • 67349266723 scopus 로고    scopus 로고
    • International Narcotics Control Board. New York: United Nations Publication
    • International Narcotics Control Board. Statistical information on narcotic drugs. New York: United Nations Publication, 2006
    • (2006) Statistical Information on Narcotic Drugs
  • 14
    • 0003756639 scopus 로고    scopus 로고
    • [online]. Available from URL: [Accessed 2009 Sep 4]
    • UK NHS Information Centre. Prescription cost analysis: England 2007 [online]. Available from URL: http://www.ic.nhs.uk/statistics-and-data- collections/ primary-care/prescriptions/prescription-cost-analysis-2007 [Accessed 2009 Sep 4]
    • (2007) Prescription Cost Analysis: England
  • 15
    • 70349131372 scopus 로고    scopus 로고
    • Arzneiverordnungs-Report 2008: Aktuelle Daten, Kosten
    • Schwabe U, Paffrath D. Arzneiverordnungs-Report 2008: Aktuelle Daten, Kosten, Trends und Kommentare. Berlin: Springer, 2008: 232-237
    • (2008) Trends und Kommentare , pp. 232-237
    • Schwabe, U.1    Paffrath, D.2
  • 16
    • 39049096218 scopus 로고    scopus 로고
    • Oral abuse of fentanyl patches (Duragesic): Seven case reports
    • Woodall KL, Martin TL, McLellan BA. Oral abuse of fentanyl patches (Duragesic): seven case reports. J Forensic Sci 2008; 53 (1): 222-225
    • (2008) J Forensic Sci , vol.53 , Issue.1 , pp. 222-225
    • Woodall, K.L.1    Martin, T.L.2    McLellan, B.A.3
  • 17
    • 0141682548 scopus 로고    scopus 로고
    • Fentanyl use,misuse, and abuse: A summary of 23 postmortem cases
    • Kuhlman Jr JJ,McCaulley R, Valouch TJ, et al. Fentanyl use,misuse, and abuse: a summary of 23 postmortem cases. J Anal Toxicol 2003; 27 (7): 499-504
    • (2003) J Anal Toxicol , vol.27 , Issue.7 , pp. 499-504
    • Kuhlman Jr., J.J.1    McCaulley, R.2    Valouch, T.J.3
  • 18
    • 33750170409 scopus 로고    scopus 로고
    • Fentanyl-related deaths in Ontario, Canada: Toxicological findings and circumstances of death in 112 cases (2002-2004)
    • Martin TL, Woodall KL, McLellan BA. Fentanyl-related deaths in Ontario, Canada: toxicological findings and circumstances of death in 112 cases (2002-2004). J Anal Toxicol 2006; 30 (8): 603-610
    • (2006) J Anal Toxicol , vol.30 , Issue.8 , pp. 603-610
    • Martin, T.L.1    Woodall, K.L.2    McLellan, B.A.3
  • 19
    • 0344237244 scopus 로고    scopus 로고
    • Severe respiratory depression and sedation with transdermal fentanyl: Four case studies
    • Regnard C, Pelham A. Severe respiratory depression and sedation with transdermal fentanyl: four case studies. Palliat Med 2003; 17 (8): 714-716
    • (2003) Palliat Med , vol.17 , Issue.8 , pp. 714-716
    • Regnard, C.1    Pelham, A.2
  • 20
    • 0031762766 scopus 로고    scopus 로고
    • Heat-related toxicity with the fentanyl transdermal patch
    • Newshan G. Heat-related toxicity with the fentanyl transdermal patch. J Pain Symptom Manage 1998; 16 (5): 277-278
    • (1998) J Pain Symptom Manage , vol.16 , Issue.5 , pp. 277-278
    • Newshan, G.1
  • 21
    • 0037439507 scopus 로고    scopus 로고
    • Heat-associated increase in transdermal fentanyl absorption
    • Carter KA. Heat-associated increase in transdermal fentanyl absorption. Am J Health Syst Pharm 2003; 60 (2): 191-192
    • (2003) Am J Health Syst Pharm , vol.60 , Issue.2 , pp. 191-192
    • Carter, K.A.1
  • 22
    • 0034865686 scopus 로고    scopus 로고
    • Opioid overdose in a patient using a fentanyl patch during treatment with a warming blanket
    • Frolich MA, Giannotti A, Modell JH. Opioid overdose in a patient using a fentanyl patch during treatment with a warming blanket. Anesth Analg 2001; 93 (3): 647-648
    • (2001) Anesth Analg , vol.93 , Issue.3 , pp. 647-648
    • Frolich, M.A.1    Giannotti, A.2    Modell, J.H.3
  • 23
    • 34249908675 scopus 로고    scopus 로고
    • Ortho-Mc-Neal-Janssen Pharmaceuticals. [online]. Available from URL: [Accessed 2009 Aug 6]
    • Ortho-Mc-Neal-Janssen Pharmaceuticals. Duragesic®: full prescribing information [online]. Available from URL: http://www.duragesic.com/duragesic/ shared/pi/duragesic.pdf#zoom=100 [Accessed 2009 Aug 6]
    • Duragesic®: Full Prescribing Information
  • 24
    • 0025646435 scopus 로고
    • Pharmacokinetics of fentanyl administered by computer-controlled infusion pump
    • Shafer SL, Varvel JR, Aziz N, et al. Pharmacokinetics of fentanyl administered by computer-controlled infusion pump. Anesthesiology 1990; 73: 1091-1102
    • (1990) Anesthesiology , vol.73 , pp. 1091-1102
    • Shafer, S.L.1    Varvel, J.R.2    Aziz, N.3
  • 25
    • 0034814432 scopus 로고    scopus 로고
    • The concentration-effect relationship of the respiratory depressant effects of alfentanil and fentanyl
    • Mildh LH, Scheinin H, Kirvela OA. The concentration-effect relationship of the respiratory depressant effects of alfentanil and fentanyl. Anesth Analg 2001; 93 (4): 939-946
    • (2001) Anesth Analg , vol.93 , Issue.4 , pp. 939-946
    • Mildh, L.H.1    Scheinin, H.2    Kirvela, O.A.3
  • 26
    • 33846012170 scopus 로고    scopus 로고
    • Mechanism-based PK/PD modeling of the respiratory depressant effect of buprenorphine and fentanyl in healthy volunteers
    • Yassen A, Olofsen E, Romberg R, et al. Mechanism-based PK/PD modeling of the respiratory depressant effect of buprenorphine and fentanyl in healthy volunteers. Clin Pharmacol Ther 2007; 81 (1): 50-58
    • (2007) Clin Pharmacol Ther , vol.81 , Issue.1 , pp. 50-58
    • Yassen, A.1    Olofsen, E.2    Romberg, R.3
  • 27
    • 0021979044 scopus 로고
    • EEG quantitation of narcotic effect: The comparative pharmacodynamics of fentanyl and alfentanil
    • Scott JC, Ponganis KV, Stanski DR. EEG quantitation of narcotic effect: the comparative pharmacodynamics of fentanyl and alfentanil. Anesthesiology 1985; 62: 234-241
    • (1985) Anesthesiology , vol.62 , pp. 234-241
    • Scott, J.C.1    Ponganis, K.V.2    Stanski, D.R.3
  • 28
    • 0025007297 scopus 로고
    • Steady-state infusions of opioids in human: II. Concentration-effect relationships and therapeutic margins
    • Hill HF, Chapman CR, Saeger LS, et al. Steady-state infusions of opioids in human: II. Concentration-effect relationships and therapeutic margins. Pain 1990; 43 (1): 69-79
    • (1990) Pain , vol.43 , Issue.1 , pp. 69-79
    • Hill, H.F.1    Chapman, C.R.2    Saeger, L.S.3
  • 29
    • 70349135694 scopus 로고    scopus 로고
    • SMAT: Fachinformation/prescribing information
    • Janssen-Cilag GmbH. Durogesic® SMAT: Fachinformation/prescribing information. Neuss: Janssen-Cilag GmbH, 2006
    • (2006) Neuss: Janssen-Cilag GmbH
  • 30
    • 0029066143 scopus 로고
    • Biopharmaceutics of a new transdermal fentanyl device.
    • Fiset P, Cohane C, Browne S, et al. Biopharmaceutics of a new transdermal fentanyl device. Anesthesiology 1995; 83 (3): 459-469
    • (1995) Anesthesiology , vol.83 , Issue.3 , pp. 459-469
    • Fiset, P.1    Cohane, C.2    Browne, S.3
  • 31
    • 0034810431 scopus 로고    scopus 로고
    • Inefficacy of high-dose transdermal fentanyl in a patient with neuropathic pain, a case report
    • discussion 329-331
    • Bleeker CP, Bremer RC, Dongelmans DA, et al. Inefficacy of high-dose transdermal fentanyl in a patient with neuropathic pain, a case report. Eur J Pain 2001; 5 (3): 325-39; discussion 329-331
    • (2001) Eur J Pain , vol.5 , Issue.3 , pp. 325-339
    • Bleeker, C.P.1    Bremer, R.C.2    Dongelmans, D.A.3
  • 32
    • 0035695653 scopus 로고    scopus 로고
    • Transdermal fentanyl: An updated review of its pharmacological properties and therapeutic efficacy in chronic cancer pain control
    • Muijsers RB, Wagstaff AJ. Transdermal fentanyl: an updated review of its pharmacological properties and therapeutic efficacy in chronic cancer pain control. Drugs 2001; 61 (15): 2289-2307
    • (2001) Drugs , vol.61 , Issue.15 , pp. 2289-2307
    • Muijsers, R.B.1    Wagstaff, A.J.2
  • 33
    • 33745278000 scopus 로고    scopus 로고
    • Pharmacokinetics, tolerability, and performance of a novel matrix transdermal delivery system of fentanyl relative to the commercially available reservoir formulation in healthy subjects
    • Marier JF, Lor M, Potvin D, et al. Pharmacokinetics, tolerability, and performance of a novel matrix transdermal delivery system of fentanyl relative to the commercially available reservoir formulation in healthy subjects. J Clin Pharmacol 2006; 46 (6): 642-653
    • (2006) J Clin Pharmacol , vol.46 , Issue.6 , pp. 642-653
    • Marier, J.F.1    Lor, M.2    Potvin, D.3
  • 36
    • 0024356047 scopus 로고
    • Absorption characteristics of transdermally administered fentanyl
    • Varvel JR, Shafer SL, Hwang SS, et al. Absorption characteristics of transdermally administered fentanyl. Anesthesiology 1989; 70 (6): 928-934
    • (1989) Anesthesiology , vol.70 , Issue.6 , pp. 928-934
    • Varvel, J.R.1    Shafer, S.L.2    Hwang, S.S.3
  • 37
    • 0025907775 scopus 로고
    • Electroencephalographic quantitation of opioid effect: Comparative pharmacodynamics of fentanyl and sufentanil
    • Scott JC, Cooke JE, Stanski DR. Electroencephalographic quantitation of opioid effect: comparative pharmacodynamics of fentanyl and sufentanil. Anesthesiology 1991; 74 (1): 34-42
    • (1991) Anesthesiology , vol.74 , Issue.1 , pp. 34-42
    • Scott, J.C.1    Cooke, J.E.2    Stanski, D.R.3
  • 38
    • 33845412248 scopus 로고    scopus 로고
    • Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation
    • Marier JF, Lor M, Morin J, et al. Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation. Br J Clin Pharmacol 2007; 63 (1): 121-124
    • (2007) Br J Clin Pharmacol , vol.63 , Issue.1 , pp. 121-124
    • Marier, J.F.1    Lor, M.2    Morin, J.3
  • 39
    • 0033451344 scopus 로고    scopus 로고
    • From the Food and Drug Administration: Review of generic bioequivalence studies
    • Henney JE. From the Food and Drug Administration: review of generic bioequivalence studies. JAMA 1999; 282 (21): 1995
    • (1999) JAMA , vol.282 , Issue.21 , pp. 1995
    • Henney, J.E.1
  • 40
    • 84967050201 scopus 로고    scopus 로고
    • Generic drug products demonstrate small differences in bioavailability relative to the brand name counterparts: A review of ANDAs approved 1996- 2005
    • Apr 18-20; Washington, DC
    • Nwakama PE, Haidar SH, Yang YS, et al. Generic drug products demonstrate small differences in bioavailability relative to the brand name counterparts: a review of ANDAs approved 1996-2005. 12th Annual FDA Science Forum; 2006 Apr 18-20; Washington, DC
    • (2006) 12th Annual FDA Science Forum
    • Nwakama, P.E.1    Haidar, S.H.2    Yang, Y.S.3
  • 41
    • 0023145749 scopus 로고
    • Decreased fentanyl and alfentanil dose requirements with age. A simultaneous pharmacokinetic and pharmacodynamic evaluation
    • Scott JC, Stanski DR. Decreased fentanyl and alfentanil dose requirements with age. A simultaneous pharmacokinetic and pharmacodynamic evaluation. J Pharmacol Exp Ther 1987; 240 (1): 159-166
    • (1987) J Pharmacol Exp Ther , vol.240 , Issue.1 , pp. 159-166
    • Scott, J.C.1    Stanski, D.R.2
  • 42
  • 43
    • 0020508539 scopus 로고
    • Clinical pharmacokinetics of fentanyl and its newer derivatives
    • Mather LE. Clinical pharmacokinetics of fentanyl and its newer derivatives. Clin Pharmacokinet 1983; 8 (5): 422-446
    • (1983) Clin Pharmacokinet , vol.8 , Issue.5 , pp. 422-446
    • Mather, L.E.1
  • 44
    • 0025757077 scopus 로고
    • Pharmacokinetics pharmacodynamics, and rational opioid selection
    • Shafer SL, Varvel JR. Pharmacokinetics pharmacodynamics, and rational opioid selection. Anesthesiology 1991; 74: 53-63
    • (1991) Anesthesiology , vol.74 , pp. 53-63
    • Shafer, S.L.1    Varvel, J.R.2
  • 45
    • 0030774527 scopus 로고    scopus 로고
    • Fentanyl metabolism by human hepatic and intestinal cytochrome P450 3A4: Implications for interindividual variability in disposition, efficacy, and drug interactions
    • Labroo RB, Paine MF, Thummel KE, et al. Fentanyl metabolism by human hepatic and intestinal cytochrome P450 3A4: implications for interindividual variability in disposition, efficacy, and drug interactions. DrugMetab Dispos 1997; 25 (9): 1072-1080
    • (1997) DrugMetab Dispos , vol.25 , Issue.9 , pp. 1072-1080
    • Labroo, R.B.1    Paine, M.F.2    Thummel, K.E.3
  • 46
    • 0036168920 scopus 로고    scopus 로고
    • Drug interactions with patient-controlled analgesia
    • Lötsch J, Skarke C, Tegeder I, et al. Drug interactions with patient-controlled analgesia. Clin Pharmacokinet 2002; 41 (1): 31-57
    • (2002) Clin Pharmacokinet , vol.41 , Issue.1 , pp. 31-57
    • Lötsch, J.1    Skarke, C.2    Tegeder, I.3
  • 47
    • 0020466945 scopus 로고
    • Fentanyl pharmacokinetics in anaesthetized patients with cirrhosis
    • Haberer JP, Schoeffler P, Couderc E, et al. Fentanyl pharmacokinetics in anaesthetized patients with cirrhosis. Br J Anaesth 1982; 54 (12): 1267-1270
    • (1982) Br J Anaesth , vol.54 , Issue.12 , pp. 1267-1270
    • Haberer, J.P.1    Schoeffler, P.2    Couderc, E.3
  • 48
    • 0030762608 scopus 로고    scopus 로고
    • Fentanyl pharmacokinetics in patients undergoing renal transplantation
    • Koehntop DE, Rodman JH. Fentanyl pharmacokinetics in patients undergoing renal transplantation. Pharmacotherapy 1997; 17 (4): 746-752
    • (1997) Pharmacotherapy , vol.17 , Issue.4 , pp. 746-752
    • Koehntop, D.E.1    Rodman, J.H.2
  • 49
  • 50
    • 56449126995 scopus 로고    scopus 로고
    • Fentanyl postmortem redistribution: Preliminary findings regarding the relationship among femoral blood and liver and heart tissue concentrations
    • Luckenbill K, Thompson J, Middleton O, et al. Fentanyl postmortem redistribution: preliminary findings regarding the relationship among femoral blood and liver and heart tissue concentrations. J Anal Toxicol 2008; 32 (8): 639-643
    • (2008) J Anal Toxicol , vol.32 , Issue.8 , pp. 639-643
    • Luckenbill, K.1    Thompson, J.2    Middleton, O.3
  • 51
    • 53849122389 scopus 로고    scopus 로고
    • Therapeutic Products Directorate Health Canada. Guidance for industry. Ottawa: Health Canada, Jun [online]. Available from URL: [Accessed 2009 Sep 4]
    • Therapeutic Products Directorate, Health Canada. Guidance for industry. Bioequivalence requirements: critical dose drugs. Ottawa: Health Canada, 2006 Jun 7 [online]. Available from URL: http://www.hc-sc.gc.ca/dhp-mps/ prodpharma/applic-demande/guide-ld/bio/critical-dose-critique-eng.php [Accessed 2009 Sep 4]
    • (2006) Bioequivalence Requirements: Critical Dose Drugs
  • 52
    • 70349085968 scopus 로고    scopus 로고
    • Bioequivalence and labelling of medicinal products with regard to generic substitution
    • Jul 13 [online]. Available from URL: [Accessed 2009 Sep 4]
    • Thirstrup S. Bioequivalence and labelling of medicinal products with regard to generic substitution. Copenhagen: Danish Medicines Agency, 2005 Jul 13 [online]. Available from URL: http://www.dkma.dk/1024/visUKLSArtikel. asp?artikelID=6437 [Accessed 2009 Sep 4]
    • (2005) Copenhagen: Danish Medicines Agency
    • Thirstrup, S.1
  • 53
    • 70349140754 scopus 로고    scopus 로고
    • Neues zur Aut-Idem Regelung: ist die Aut-idem-Regelung auch bei Schmerzpflastern anwendbar?
    • [online]. Available from URL: [Accessed 2009 Aug 17]
    • Bundesinstitut fur Arzneimittel und Medizinprodukte [BfArM]. Neues zur Aut-Idem Regelung: ist die Aut-idem-Regelung auch bei Schmerzpflastern anwendbar? Bonn: BfArM, 2008 [online]. Available from URL: http://www. bfarm.de/cln-028/nn-683944/SharedDocs/FAQ/DE/BtmGrundstoffeAMVV/ BtM/Rezepte/t2-verschr-ambul/ha-t2-BTMRezepte-faq8.html [Accessed 2009 Aug 17]
    • (2008) Bonn: BfArM


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