UCB Pharma Limited

208 Bath Road, Slough, Berkshire, SL1 3WE
Telephone: +44 (0)1753 534 655
Medical Information Direct Line: +44 (0)1753 447 690
Medical Information e-mail: Medicalinformationuk@ucb.com
Customer Care direct line: +44 (0) 1773 510123

Summary of Product Characteristics last updated on the eMC: 15/07/2011
SPC Parvolex 200 mg/ml Concentrate for Solution for 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 15/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Correction of section 4.4
Excipient warning for sodium content added. 
Updated on 27/01/2011 and displayed until 15/07/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 1: Update of name to: Parvolex 200 mg/ml Concentrate for Solution for Infusion
Updated on 05/05/2010 and displayed until 27/01/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2: correction of typo - Sodium content 3.22.6 mg.
Updated on 07/04/2010 and displayed until 05/05/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   18-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 - information on haemostatic parameters and caution in children because of risk of fluid overload.
Section 4.8 - additional side effect of prothrombin time abnormal
Updated on 04/03/2010 and displayed until 07/04/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2: Addition of sodium content
Section 4.4: Sodium content warning added
Updated on 15/09/2005 and displayed until 04/03/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/01/2003 and displayed until 15/09/2005
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients
Updated on 05/10/2001 and displayed until 24/01/2003
Reasons for adding or updating:
  • New SPC for new product
Updated on 25/08/2001 and displayed until 05/10/2001
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 06/09/1999 and displayed until 25/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   acetylcysteine