EMA/PE/0000183637

## Key facts Active substance humanised afucosylated IgG1 monoclonal antibody against CCR8 Therapeutic area Neoplasms benign, malignant and unspecified (incl cysts and polyps) Decision number EMA/PE/0000183637 PIP number EMA/PE/0000183637 Pharmaceutical form(s) Solution for injection Condition(s) / indication(s) Treatment of all conditions included in the category of malignant neoplasms (except melanoma, nervous system, haematopoietic and lymphoid tissue) Route(s) of administration Subcutaneous use Intravenous use Contact for public enquiries Bristol-Myers Squibb Pharma EEIG United Kingdom E-mail: medinfo.emea@bms.com Tel. +44 (0)189 552 3686 ax +44 (0)189 552 3788 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 21/03/2025 Compliance check done No ## Decision EMA/PE/0000183637 : EMA decision of 21 March 2025 on the granting of a product specific waiver for humanised afucosylated IgG1 monoclonal antibody against CCR8 Adopted Reference Number: EMADOC-1700519818-1974851 English (EN) (230.5 KB - PDF) First published: 04/06/2026 View