LYMPHOSEEK® (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life.

Summary 

• Due to manufacturing difficulties, a supply shortage of LYMPHOSEEK on the EU market is foreseen until Q2 2022.
• 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 May 2022:

Lot numbers
347446    349863    349878
347447    349864    349882
347448    349865    349883
349046    349866    349885
                   349867

• This information must be shared with those who will be administering the product.
• The 6-month extension of expiry date from 30 November 2021 to 31 May 2022 is based on an analysis of the stability data for LYMPHOSEEK and applies to the above lots only.

Background 
Navidea Biopharmaceuticals Europe Ltd has now replaced Norgine B.V. as the new Marketing Authorisation Holder for Lymphoseek. LYMPHOSEEK (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.

Stability data for LYMPHOSEEK have been submitted to the EMA and in view of ongoing manufacturing issues, it has been exceptionally agreed to allow use of the above mentioned lots for a further 6 months after expiry date, until 31 May 2022. After this date any remaining stock should be disposed of as per usual procedure.

No safety concerns were identified during the data review which led to a decision to permit use of the above identified lots until 31 May 2022.

Published on: 07 December 2021