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Recombinant oligomeric gp145 C.6980 Clade C HIV Env protein

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Required Documentation Based on 45 CFR 46

Required documentation of risk/benefit category and approval of clinical studies for inclusion of children by institutional review boards/ethics committees based on 45 CFR 46, Subpart D.

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Ribavirin

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Ribavirin (Ribasphere) Package Insert

Ribasphere is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients…

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Ribavirin Tablet, Package Insert

Ribavirin is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients…

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Rifabutin Package Insert

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Rifafour e-276 (Rifampin/Isoniazid/Pyrazinamide/Ethambutol)

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Rifampicin Package Insert

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Rifampin

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Rifampin Capsules, Package Insert

Rifampin is indicated in the treatment of all forms of tuberculosis.

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Rifapentine

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Rifapentine (Priftin)

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

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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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RV460 (ALF43)

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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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Semaglutide (Ozempic) Package Insert

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