17:58 May 23, 2017 |
Danish to English translations [PRO] Medical - Medical: Pharmaceuticals / corporate structure | |||||||
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| Selected response from: Charles Ek United States Local time: 08:44 | ||||||
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Summary of answers provided | ||||
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4 | unauthorised medicinal product |
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2 +1 | unlicensed medicine |
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1 | unapproved compounded medication / unapproved prescription drug |
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unlicensed medicine Explanation: Maybe this is it. https://www.britishpainsociety.org/static/uploads/resources/files/useofmeds_professional_final.pdf |
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unauthorised medicinal product Explanation: "The compassionate use procedure is laid down in Article 83 of Regulation (EC) No 726/2004. It refers to the use of an unauthorised medicinal product under limited and strictly controlled conditions to allow certain patients earlier access to medicines. The concept goes back to Directive 2001/83/EC: Member States can make national arrangements for health professionals to commission the manufacture of an unauthorised medicine to fulfil the 'special needs' of a patient under their 'direct personal responsibility'." Reference: http://www.europarl.europa.eu/RegData/etudes/IDAN/2015/55417... |
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unapproved compounded medication / unapproved prescription drug Explanation: Unapproved Drugs List https://www.ijpc.com/Patient_Info/Unapproved_Drugs.pdf All compounded medications, including pediatric preparations, HRT preparations, cancer combinations, intravenous admixtures, pain management medications, high-dose pain medications, medications in short supply, discontinued medications, dye-free, preservative-free, fragrance-free medications, infant medications, small children medications, new therapeutic approaches to difficult to treat diseases, drugs compounded for clinical studies ... Yes, there are many vitally important unapproved drugs that are commercially available today. Unapproved Prescription Drugs: Drugs Marketed in the United States ... https://www.fda.gov/drugs/.../selectedenforcementactionsonun... 3 ene. 2017 - Because unapproved and illegally marketed prescription and over-the-counter drugs pose a significant public health concern, the FDA has ... Unapproved Prescription Drugs: FDA Actions https://www.fda.gov/Drugs/.../SelectedEnforcementActionsonUn... Since publication of the Compliance Policy Guide (CPG) for Marketed Unapproved Drugs (drugs marketed without approved NDAs and ANDAs) (CPG Sec. How Unapproved Drugs Make it to Market | TIME.com healthland.time.com/.../how-do-unapproved-drugs-make-it-to-ma... 3 mar. 2011 - It may come as a surprise that some of the drugs your doctor can prescribe have not been approved by the Food and Drug Administration (FDA) ... Prescription Drugs UNAPPROVED by the FDA - Vaughn's Summaries www.vaughns-1-pagers.com/.../prescription-drugs-unapproved.... 4 mar. 2015 - Doctors write 65 million prescriptions each year for unapproved drugs. The FDA has REFUSED to provide a list of unapproved drugs, in spite of ... |
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