Consumer Product Safety Improvement Act.

The Consumer Product Safety Improvement Act of 2008 (CPSIA) requires manufacturers and importers of certain consumer products (including certain drug products) manufactured on or after November 12, 2008, to certify that their products comply with all applicable rules, bans, standards, or regulations enforced by the Consumer Product Safety Commission (CPSC). Under the CPSIA, manufacturers and importers must make available to customers a certificate specifying that the product complies with the applicable CPSC rule, ban, standard, or regulation. Such certification must be based on a test of each product or upon a reasonable testing program.

Corlanor® (ivabradine)

Corlanor® is sold in special child-resistant packaging that must meet the requirements of the Poison Prevention Packaging Act. Accordingly, Amgen furnishes below links to the General Conformity Certificates for the product identified by corresponding finished drug product batch number.

2014 General Conformity Certificates identified by corresponding finished drug product batch number.

7.5 mg.
1078829    

2015 General Conformity Certificates identified by corresponding finished drug product batch number.

5 mg.
1059602 1059603 1059604
1059605 1059674 1059675
1060111 1060112 1060580
1061397 1065693 1078828
7.5 mg.
1059607 1059608 1060113
1060581

2016 General Conformity Certificates identified by corresponding finished drug product batch number.

5 mg.
1068060 1069973 1083597
7.5 mg.
1068941 1083599

For questions, please call Amgen Medical Information at 1-800-77AMGEN (1-800-772-6436).