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Drugs

Information on pharmaceutical drugs, side effects and labelling

Effient (prasugrel)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 USE IN SPECIFIC POPULATIONS PLLR Conversion: Pregnancy Risk Summary There are no data with Effient use…

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Dulera (formoterol fumarate, mometasone furoate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 USE IN SPECIFIC POPULATIONS PLLR Conversion: Pregnancy Risk Summary There are no randomized clinical studies… Powered by WPeMatico

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Dexilant (dexlansoprazole delayed-release capsules)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 ADVERSE REACTIONS Clinical Trials Experience Pediatrics (additional section added) The safety of DEXILANT…

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Clinolipid (lipid injectable emulsion)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 ADVERSE REACTIONS Post-marketing Experience Immune System Disorders: Hypersensitivity with the manifestations of rash..

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Asmanex HFA (mometasone furoate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 USE IN SPECIFIC POPULATIONS PLLR Conversion: Pregnancy Risk Summary There are no randomized clinical studies…

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Alinia (nitazoxanide)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 PLR Conversion; please refer to label. ADVERSE REACTIONS (updated) Clinical Trials Experience Because clinical…

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Thallous Chloride T1201 Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Risk of Extravasation and Tissue Damage (and Tissue Damage added) Addition of:  Confirm…

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Dysport (abobotulinumtoxinA)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in labeling: (additions) …

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Yondelis (trabectedin)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Hepatotoxicity Assess LFTs prior to each administration of YONDELIS and as clinically…

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