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

Summary of Product Characteristics last updated on the eMC: 16/08/2011
SPC Refludan 50 mg powder for solution for injection or infusion

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 16/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
  • Change to MA holder contact details
Date of revision of text on the SPC:   11-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.8 - correction of typing error from Refuldan to Refludan.

Section 7 - MA Holders address updated

Section 10 - Date of revision updated to 11 August 2011
Updated on 04/09/2007 and displayed until 16/08/2011
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.8 (undesirable effects) - Brought in line with MedDRA
 
Section 9 - Change to Date of Renewal
Updated on 15/02/2007 and displayed until 04/09/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   lepirudin