THALIDOMIDE CELGENE Hard capsule Ref.[8640] Active ingredients: Thalidomide

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands

Product name and form

Thalidomide Celgene 50 mg hard capsules.

Pharmaceutical Form

Hard capsule.

White opaque capsules marked “Thalidomide Celgene 50 mg”.

Qualitative and quantitative composition

Each capsule contains 50 mg of thalidomide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Thalidomide

Thalidomide shows immunomodulatory, anti-inflammatory and potential anti-neoplastic activities. Thalidomide is also a non-barbiturate centrally active hypnotic sedative. It has no antibacterial effects.

List of Excipients

Capsule contents:

Starch, pregelatinised
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)

Printing ink:

Shellac
Black iron oxide (E172)
Propylene glycol

Pack sizes and marketing

PVC/PCTFE/aluminium blister containing 14 capsules.

Pack sizes: 28 capsules (two blisters) in a wallet card.

Marketing authorization holder

Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands

Marketing authorization dates and numbers

EU/1/08/443/001

Date of first authorisation: 16 April 2008
Date of latest renewal: 08 February 2018

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