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Rems
Results: 587

#	Item
511	FORTESTA® (testosterone) gel CIII Class of Drug: Androgen Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Neuroendocrinology Testosterone Rems Package insert Endocrine system Medicine Androgens
512	Initial REMS Approval: December[removed]NDA[removed]SUBOXONE (buprenorphine and naloxone) sublingual tablet CIII Add to Reading List Source URL: www.fda.gov Language: English Alcohols Morphinans Drug rehabilitation Ketones Dosage forms Buprenorphine Naloxone Opioid dependence Drug Addiction Treatment Act Chemistry Organic chemistry Pharmacology
513	Most recent modification: [removed]Initial REMS Approval: [removed]NDA[removed]Caprelsa® (vandetanib) Add to Reading List Source URL: www.fda.gov Language: English Cardiac dysrhythmia Pharmacology Organofluorides Clinical pharmacology Medical prescription Patient safety Torsades de pointes Pharmacist Vandetanib Chemistry Medicine Health
514	Initial REMS Approval: [removed]NDA[removed]OPSUMIT (macitentan) Endothelin Receptor Antagonist Sponsor: Actelion Pharmaceuticals Ltd Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Medical prescription Patient safety Pharmacology Actelion Pharmacist Pharmacy Pregnancy Medicine Pharmaceutical sciences Health
515	Initial REMS Approval: [removed]Most Recent Modification: October/2013 NDA[removed]ENTEREG (alvimopan) Cubist Pharmaceuticals, Inc. Add to Reading List Source URL: www.fda.gov Language: English Organic chemistry Alvimopan Amides Phenols Piperidines Pharmacist Hospital pharmacy Rad Chemistry Pharmacy Pharmaceutical sciences
516	Initial REMS Approval: [removed]Most Recent Modification: [removed]BLA[removed]STELARA® (ustekinumab) Human interleukin 12 and 23 antagonist RISK EVALUATION AND MITIGATION STRATEGY (REMS) Add to Reading List Source URL: www.fda.gov Language: English Immunology Pharmacology Tuberculosis Psoriasis Centocor Ustekinumab Tuberculosis treatment Latent tuberculosis Psoriatic arthritis Medicine Immunosuppressants Monoclonal antibodies
517	Initial REMS approval: [removed]Most recent modification: [removed]BLA[removed]MYALEPT™ (metreleptin) Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical sciences Clinical pharmacology Medical prescription Patient safety Eli Lilly and Company Leptin Methadone Pharmacy Chemistry Pharmacology Peptide hormones
518	Bauen, Sanieren und Energiesparen im Rems-Murr-Kreis Bau’ recht! Frank Fliegner Add to Reading List Source URL: www.total-lokal.de Language: German - Date: 2014-06-06 03:54:49
519	REMS TEMPLATE October 21, [removed]REVISED APPENDIX A: REMS TEMPLATE If you are not proposing to include one of the listed elements, include a statement that the element is not necessary. Application number TRADE NAME (DRU Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Pharmacology Therapeutics United States Public Health Service Rad Append Pharmaceutical sciences Computing Clinical research
520	Guidance Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Patient safety Clinical pharmacology Medical terms Pharmaceuticals policy Medical prescription Package insert Prescription medication Pharmacy Medicine Health Pharmacology

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