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Rems
Results: 587

#	Item
501	Initial REMS Approved: March[removed]Most Recent Modification: July 2013 NDA[removed]VIVITROL® (naltrexone for extended-release injectable suspension) Opioid Antagonist Add to Reading List Source URL: www.fda.gov Language: English Morphinans Alcohols Euphoriants Phenols Ketones Naltrexone Buprenorphine Methadone Heroin Chemistry Medicine Organic chemistry
502	risk-management-plan.pdf Page 1 of 10 Lumizyme® (alglucosidase alfa[removed]Risk Evaluation and Mitigation Strategy (REMS) Initial REMS Approval: [removed]Most Recent Modification: [removed] Add to Reading List Source URL: www.fda.gov Language: English Glycogen storage disease type II Hepatology Alglucosidase alfa Genzyme Pharmacist Medicine Health Rare diseases
503	Initial REMS Approval: [removed]Most Recent Modification: [removed]Amgen Inc. Add to Reading List Source URL: www.fda.gov Language: English Amgen Pharmacology Denosumab Osteoporosis Endocrinology Pharmaceutical drug Osteonecrosis of the jaw Rheumatology Medicine Anatomy Health
504	NDA[removed]LetairisÒ (ambrisentan) RISK EVALUATION AND MITIGATION STRATEGY (REMS) Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceuticals policy Clinical pharmacology Medical prescription Patient safety Pharmacist Ambrisentan Prescription medication Pregnancy Medicine Health Chemistry
505	Initial REMS Approval: [removed]Most Recent Modification: [removed]BL[removed]Nplate® (romiplostim) Amgen Inc. One Amgen Center Drive Add to Reading List Source URL: www.fda.gov Language: English Orphan drugs Antihemorrhagics Romiplostim Thrombocytopenia Idiopathic thrombocytopenic purpura Amgen Myelodysplastic syndrome Platelet Acute myeloid leukemia Medicine Blood Biology
506	Initial REMS Approved: [removed]Most Recent Modification: October/2013 BLA[removed]and BLA[removed] Add to Reading List Source URL: www.fda.gov Language: English Rheumatoid arthritis Genentech Health Immunosuppressants Anatomy Tocilizumab
507	REMS Document Initial Approval[removed]NDA[removed] Iclusig® (ponatinib) tablets Add to Reading List Source URL: www.fda.gov Language: English Ponatinib Chronic myelogenous leukemia Rems Alkynes Organofluorides Piperazines
508	Initial REMS Approval: [removed]Most Recent Modification: [removed]NDA[removed]GILENYA® (fingolimod) 0.5mg capsules Add to Reading List Source URL: www.fda.gov Language: English Immunosuppressants Multiple sclerosis Diols Fingolimod Norfloxacin Methadone Ketorolac Chemistry Organic chemistry Piperazines
509	Initial REMS Approval: [removed]Most Recent Modification: [removed]NDA[removed]Chantix (Varenicline) Tablets Add to Reading List Source URL: www.fda.gov Language: English Pfizer Smoking cessation Medicine Benzazepines Pyrazines Varenicline Food and Drug Administration Nicotine Nicotinic agonists Chemistry Pharmacology
510	Initial REMS Approval: [removed]Most Recent Modification: [removed]NDA[removed] Add to Reading List Source URL: www.fda.gov Language: English Pharmacology GlaxoSmithKline Medical prescription Pharmacist Pharmacy Thrombocytopenia Medicine Health Pharmaceutical sciences

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