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Celgene Ltd
1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB , UK
Telephone: +44 (0)208 831 8300
Medical Information Direct Line: UK: 08448 010 045 Ireland: 1800 333 111
Medical Information e-mail: medinfo.uk.ire@celgene.com
Medical Information Fax: UK: 08448 010 046 Ireland: 1800 333 112

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Summary of Product Characteristics last updated on the eMC: 10/08/2011
SPC Thalidomide Celgene 50 mg Hard Capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 10/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Removal of Black Triangle
  • Change to MA holder contact details
Date of revision of text on the SPC:   03-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - The black triangle has been removed

Section 7 - The address of the MA holder has been updated
Section 10 - The date of the revision of the text has been amended
Updated on 25/05/2011 and displayed until 10/08/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.4 - Changes to Cardiovascular disorders section. Addition of section regarding MI and alteration to section regarding VTE. Addition to section regarding patients with renal/hepatic impairment.

Section 4.5 - "Non-enzymatic hydrolysis suggests that the potential for drug-drug interactions with thalidomide is low." added to first paragraph.

Section 4.6 - title altered to "Fertility, pregnancy and lactation". Addition of "hypersensitivity, hearing impaired or deafness, renal failure, myocardial infarction and worsening of Parkinson’s disease symptoms" to adverse reaction experienced in post marketing surveillance.

Section 4.8 - Pancytopenia also added. Venous and arterial thromboembolic events section altered: "An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) has been reported in patients treated with thalidomide (see section 4.4)."

5.1 - ATC code: L04AX 02. Previously read: LO4AX

5.2 - Sentence added: "Thalidomide is metabolised almost exclusively by non-enzymatic hydrolysis." Second paragraph added under Elimination. Additional information added to Hepatic and Renal insufficiency section.

10 – Date of revision 04/05/2011
Updated on 10/05/2010 and displayed until 25/05/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   23-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.4 - Tumour Lysis Syndrome added
4.8 - Tumour Lysis Syndrome added. Febrile neutropenia added as an additional AE from post marketing experience.
5.2 - Additional information added in the Metabolism, Elimination and Hepatic and Renal Insufficiency sections.
Updated on 04/11/2009 and displayed until 10/05/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   27-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change of name from Thalidomide Pharmion 50mg Hard Capsules to Thalidomide Celgene 50mg Hard Capsules
Updated on 01/04/2009 and displayed until 04/11/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   24-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section 4.2, peripheral neuropathy guidelines have been ammended.
Updated on 22/07/2008 and displayed until 01/04/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  thalidomide