Agenzia Italiana del Farmaco
Direct communication with healthcare professionals on LYMPHOSEEK® (tilmanocept) - Direct communication with healthcare professionals on LYMPHOSEEK® (tilmanocept)
Direct communication with healthcare professionals on LYMPHOSEEK® (tilmanocept)
Summary:
- Due to manufacturing difficulties, a supply shortage of LYMPHOSEEK on the EU market is foreseen until Q1 2023.
- To allow continued use of LYMPHOSEEK, it has been exceptionally agreed with the EMA that the shelf life of the following lots can be extended until 31 March 2023:
Lot numbers
347446 | 349863 | 349878 |
347447 | 349864 | 349882 |
347448 | 349865 | 349883 |
347449 | 349866 | 349885 |
349046 | 349867 | - |
- This information must be shared with those who will be administering the product.
- The 16-month extension of expiry date from 30 November 2021 to 31 March 2023 is based on an analysis of the stability data for LYMPHOSEEK and applies to the above lots only.
Published on: 31 January 2023