# Thalidomide

Thalidomide (Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + melphalan and prednisone | 1st line | Aged ≥ 65 years or ineligible for high dose chemotherapy |

## Products

### Thalidomide Lipomed

- Company: Lipomed GmbH
- Target: Immunomodulatory agent
- ATC: L04AX02
- EU approval: 19 Sep 2022
- Label revised: 14 May 2024
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/thalidomide-lipomed-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/thalidomide-lipomed-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-lipomed

Mechanism (SmPC section 5.1): Thalidomide may act by suppressing excessive TNF-α production, down-modulating cell surface adhesion molecules involved in leukocyte migration, and through anti-angiogenic activity.

### Thalidomide BMS (previously Thalidomide Celgene)

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: Immunomodulatory agent
- ATC: L04AX02
- EU approval: 16 Apr 2008
- Label revised: 22 Jan 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/thalidomide-bms-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/thalidomide-bms-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-bms

Mechanism (SmPC section 5.1): Thalidomide's immunomodulatory and anti-neoplastic effects may relate to suppression of excess TNF-α production, down-modulation of leukocyte adhesion molecules and anti-angiogenic activity.

## Label wording

- **Thalidomide** (Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed), Multiple myeloma, 1st line: “Thalidomide BMS in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/thalidomide-bms-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/thalidomide