The ACPM advised that implementation by the sponsor of the recommendations outlined above to the satisfaction of the TGA, in addition to the evidence of efficacy and safety provided would support the safe and effective use of this product. Outcome on a review of quality, safety and efficacy, TGA approved the registration of Harvoni (ledipasvir/sofosbuvir 90 mg/400 mg) indicated for: Harvoni (ledipasvir/sofosbuvir dose combination) is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. Specific conditions of registration applying to these goods The EU RMP (Version: 0.2, dated 19 August 2014) with an ASA (Version: 0.1, dated February 2015) must be implemented for the Harvoni (ledipasvir/sofosbuvir 90 mg/400 mg) tablet. Attachment 1. Product Information The PI approved for Harvoni at the time this AusPAR was published is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report
The ACPM advised that implementation by the sponsor of the recommendations outlined above to the satisfaction of the TGA, in addition to the evidence of efficacy and safety provided would support the safe and effective use of this product. Outcome on a review of quality, safety and efficacy, TGA approved the registration of Harvoni (ledipasvir/sofosbuvir 90 mg/400 mg) indicated for: Harvoni (ledipasvir/sofosbuvir dose combination) is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. Specific conditions of registration applying to these goods The EU RMP (Version: 0.2, dated 19 August 2014) with an ASA (Version: 0.1, dated February 2015) must be implemented for the Harvoni (ledipasvir/sofosbuvir 90 mg/400 mg) tablet. Attachment 1. Product Information The PI approved for Harvoni at the time this AusPAR was published is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report
auspar-ledipasvir-sofosbuvir-151008.docx