000
| 02318nam 2200313za 4500 |
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001 | 9.833940 |
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003 | CaOODSP |
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005 | 20221107150327 |
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007 | cr ||||||||||| |
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008 | 170327s2016 oncd os f000 0 eng d |
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040 | |aCaOODSP|beng |
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041 | 0 |aeng|afre |
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043 | |an-cn--- |
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086 | 1 |aH82-27/2016-PDF |
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245 | 00|aOrphan Drug Launch Monitor (ODLM) |h[electronic resource] = |bObservateur des médicaments orphelins (OMO). |
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246 | 31|aObservateur des médicaments orphelins (OMO) |
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260 | |a[Ottawa] : |bPatented Medicine Prices Review Board, |c[2016] |
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300 | |a[1] p. : |bcol. charts |
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500 | |aCaption title. |
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500 | |aAt head of title: National Prescription Drug Utilization Information System. |
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520 | |a"To stimulate drug development, a number of countries have adopted orphan drug regulatory frameworks. These include the United States (US) (1983), Singapore (1991), Japan (1993), Australia (1997), the European Union (EU) (1999/2000), Taiwan (2000) and South Korea (2003). The Orphan Drug Launch Monitor analyzes the international approval of designated orphan drugs and assesses their availability in Canada. This analysis focuses on a number of select orphan drugs reported at the active-substance level and identified based on the following criteria: drugs that received orphan designation and approval in the US and/or EU over the last decade (2005–2014); and drugs that only have orphan indications. The international market analyzed includes Canada and the seven PMPRB comparator countries (PMPRB7): France, Germany, Italy, Sweden, Switzerland, the United Kingdom (UK) and the US. The results report on sales and prices for 2014. Based on the selection criteria, 134 orphan drugs were identified, accounting for 2.9% of the international pharmaceutical sales in 2014"--Background and approach. |
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546 | |aText in English and French. |
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692 | 07|2gccst|aDrugs |
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692 | 07|2gccst|aPharmaceutical industry |
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692 | 07|2gccst|aGovernment policy |
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710 | 1 |aCanada. |bPatented Medicine Prices Review Board. |
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710 | 2 |aNational Prescription Drug Utilization Information System (Canada) |
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792 | |tOrphan Drug Launch Monitor (ODLM) |w(CaOODSP)9.833941 |
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856 | 40|qPDF|s310 KB|uhttps://publications.gc.ca/collections/collection_2017/cepmb-pmprb/H82-27-2016.pdf |
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