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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/14/955|
|Active substance :||tilmanocept|
|ATC:||Anatomical main group: V - Various|
Therapeutic subgroup: V09 - Diagnostic radiopharmaceuticals
Pharmacological subgroup: V09I - Tumour detection
Chemical subgroup: V09IA - Technetium (99mTc) compounds
Chemical substance: V09IA09 - Technetium (99mTc) tilmanocept
(See WHO ATC Index)
|Indication:||This medicinal product is for diagnostic use only.|
Radiolabelled Lymphoseek 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.
External imaging and intraoperative evaluation may be performed using a gamma detection device.
|Marketing Authorisation Holder:||Norgine B.V.
Hogehilweg 7, 1101 CA Amsterdam, Nederland
|EPAR and active package presentations|
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|21/11/2014||Centralised - Authorisation||EMEA/H/C/2085||(2014)8901 of 19/11/2014|
|15/09/2016||Centralised - Variation||EMEA/H/C/2085/II/4|
|Updated with Decision(2017)437 of 23/01/2017|
|25/01/2017||Centralised - Transfer Marketing Authorisation Holder||EMEA/H/C/2085/T/7||(2017)437 of 23/01/2017|
|16/09/2017||Centralised - Variation||EMEA/H/C/2085/IB/10|