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Review Reports: Regenerative Medical Products

The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.

The review reports were selected for translation among those of new regenerative medical products that recently received marketing approval, in consideration of relevant factors including the novelty and priority.

EN, English; JP, Japanese

Brand Name Generic Name Approved In PDF
HeartSheet human (autologous) skeletal myoblast-derived cell sheet September 2015 PDF PDF
Initial Approval
human (autologous) epidermal cell sheet October 2007 PDF PDF
Partial Change Approval
human (autologous) epidermal cell sheet September 2016 PDF PDF
Temcell human (allogeneic) bone marrow-derived mesenchymal stem cells September 2015 PDF PDF

* This product was approved as a medical device under the previous regulatory framework.

JCN 3010005007409

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Review Reports: Regenerative Medical Products