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: [email protected]. +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

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