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Tasimelteon
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1	23 April 2015 EMA/CHMPCommittee for Medicinal Products for Human Use (CHMP) Summary of opinion 1 (initial authorisation) Add to Reading List Source URL: www.ema.europa.eu Language: English - Date: 2015-04-24 07:03:59 Health Sleep disorders Benzofurans Cyclopropanes Sedatives Tasimelteon European Medicines Agency Non-24-hour sleep-wake disorder Committee for Medicinal Products for Human Use Circadian rhythms Chemistry Biology
2	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ™ (tasimelteon) capsules, for Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-02-10 13:17:04 Benzofurans Sedatives Selective serotonin reuptake inhibitors Ethers Melatonin Fluvoxamine Tasimelteon Ramelteon Chemistry Organic chemistry Acetamides
3	Division: Pharmacy Services Subject: Prior Authorization Criteria Original Development Date: August 26, 2014 Original Effective Date: Add to Reading List Source URL: www.fdhc.state.fl.us Language: English - Date: 2014-08-28 15:32:49 Physiology Psychiatry Non-24-hour sleep-wake disorder Circadian rhythm sleep disorder Tasimelteon Melatonin Sleep Circadian rhythm Insomnia Circadian rhythms Sleep disorders Biology
4	Division: Pharmacy Services Subject: Prior Authorization Criteria Original Development Date: August 26, 2014 Original Effective Date: Add to Reading List Source URL: ahca.myflorida.com Language: English - Date: 2014-08-28 15:32:49 Physiology Psychiatry Non-24-hour sleep-wake disorder Circadian rhythm sleep disorder Tasimelteon Melatonin Sleep Circadian rhythm Insomnia Circadian rhythms Sleep disorders Biology
5	Division: Pharmacy Services Subject: Prior Authorization Criteria Original Development Date: August 26, 2014 Original Effective Date: Add to Reading List Source URL: www.fdhc.state.fl.us Language: English - Date: 2014-08-28 15:32:49 Physiology Psychiatry Non-24-hour sleep-wake disorder Circadian rhythm sleep disorder Tasimelteon Melatonin Sleep Circadian rhythm Insomnia Circadian rhythms Sleep disorders Biology
6	PRIOR AUTHORIZATION POLICY Hetlioz™ (tasimelteon capsules Vanda Pharmaceuticals) To Initiate a Coverage Review, Call[removed] Add to Reading List Source URL: statehealthplan.state.nc.us Language: English - Date: 2014-05-29 15:15:34 Biology Health Syndromes Delayed sleep phase disorder Melatonin Non-24-hour sleep-wake disorder Circadian rhythm sleep disorder Tasimelteon Insomnia Circadian rhythms Sleep disorders Sleep
7	FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) Meeting Sheraton Silver Spring Hotel, Cypress Ballroom 8777 Georgia Add to Reading List Source URL: www.fda.gov Language: English Research Clinical research Pharmaceutical industry Food and Drug Administration Cyclopropanes Tasimelteon Non-24-hour sleep-wake disorder New Drug Application Pharmaceutical sciences Health Pharmacology
8	FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) Meeting Sheraton Silver Spring Hotel, Cypress Ballroom 8777 Georgia Add to Reading List Source URL: www.fda.gov Language: English Research Clinical research Pharmaceutical industry Food and Drug Administration Cyclopropanes Tasimelteon Non-24-hour sleep-wake disorder New Drug Application Pharmaceutical sciences Health Pharmacology
9	Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting November 14, 2013 Location: The Sheraton Silver Spring Ho Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmacology Pharmaceutical industry Clinical research Cyclopropanes Tasimelteon Non-24-hour sleep-wake disorder Center for Drug Evaluation and Research New Drug Application Food and Drug Administration Health Pharmaceutical sciences
10	TASIMELTEON ADVISORY COMMITTEE MEETING BRIEFING MATERIALS 14 NOVEMBER 2013 Add to Reading List Source URL: www.fda.gov Language: English Health Non-24-hour sleep-wake disorder Tasimelteon Melatonin Circadian rhythm Entrainment Phase response curve Sleep Clinical trial Circadian rhythms Biology Physiology

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