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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 (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

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Rifampicin Package Insert

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Rifampicin/Isoniazid

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Rifampicin/Isoniazid

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Rifampicin/Isoniazid

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Rifampicin/Isoniazid (Isonarif)

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Rifampicin/Isoniazid/Pyrazinamide/Ethambutol Hydrochloride

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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) Risk List

The following serious and life-threatening side effects have been associated with the use of rilpivirine:

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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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RSC Veeva Vault eTMF Submission Form

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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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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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