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Rilpivirine (Edurant)

The following serious side effects have been associated with the use of rilpivirine: Depression or mood changes. Be sure to contact your health care provider immediately if you are feeling sad or hopeless, feeling anxious or restless, or have thoughts of hurting yourself (suicide) or have tried to…

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Rilpivirine (TMC278, Edurant) Investigator Brochure

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Ritonavir (Norvir) Tablets/Oral Solution, Package Insert

NORVIR is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

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RSV 276

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RSV 6120/DeltaNS2/1030s

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RSV D46/NS2/N/deltaM2-2-HindIII

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RSV DeltaNS2-Delta1313-I1314L

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rVSV HIV Vaccines

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Safety Workshop October 2016

.zip file contains: Case review on adverse events Safety training presentations on adverse events, expedited reporting and assessment, Expedited reporting via DAERS a safety training case study handout Training given in the Republic of South Africa in October 2016.

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SAR441236

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Selzentry (maraviroc) Tablets and Oral Solution, Package Insert

SELZENTRY is a CCR5 co-receptor antagonist indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older weighing at least 10 kg.

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Signature Requirement Guidance

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Sofosbuvir/Velapatasvir (Epclusa)

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Study Physician Attestation and Agreement for Electronic Signatures

This form is to document that the signator of this document is authorized to use the DAIDS-ES system, and understands that their electronic signature (eSignature) is used to electronically sign database records.

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Study Statuses

Study statuses and milestones handout.

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Tamoxifen Citrate Package Insert

Tamoxifen Citrate Tablets USP, a nonsteroidal antiestrogen, are for oral administration.

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Tenofovir Alafenamide/Elvitegravir

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Tenofovir Disoproxil Fumarate (Viread) Package Insert

VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1) VIREAD is indicated…

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Tenofovir Disoproxil Fumarate (Viread) Risk List

The following side effects have been associated with the use of tenofovir:

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Tenofovir Gel

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Tenofovir Vaginal Ring

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Translation Confirmation Document

DAIDS protocol registration translation confirmation document.

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Trimethoprim/Sulfamethoxazole (Septra) Package Insert

SEPTRA (trimethoprim and sulfamethoxazole) is a synthetic antibacterial combination product. Each SEPTRA Tablet contains 80 mg trimethoprim and 400 mg sulfamethoxazole and the inactive ingredients docusate sodium (0.4 mg per tablet), FD&C Red No. 40, magnesium stearate, povidone, and sodium…

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Uganda - DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events

Presentation from webinar on using the Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0.

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Uganda - Expedited Reporting to DAIDS and DAERS Refresher June 2014

Zip file contains: Presentation slides from ACTG June 2014 network meeting Presentation to ACTG about expedited reporting on Adverse Events Presentation to ACTG about reporting via DAERS Case study on Adverse Events Case Study on chest pain

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