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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 medicines.ie: 25/01/2011
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 medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 25/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   01-Dec-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Changes in line with current guidelines and resulted from the grant of the Renewal application.
Updated on 07/08/2008 and displayed until 25/01/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
Date of revision of text on the SPC:   07/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to section 4.2 incude adding a maximum ceiling weight of 110 kg when calculating the dose for obese patients.
Changes to section 4.4 include additional warning for patients at risk of fluid overload.
Changes to section 4.5 include possible interaction with carbamazapine.
Changes to section 4.8 include additional possible adverse effects of abnormal thinking, gait disturbance and increase or decrease in prothrombin times.
Updated on 28/08/2007 and displayed until 07/08/2008
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
General update of statutory infomation
Updated on 12/08/2005 and displayed until 28/08/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Updated on 27/09/2004 and displayed until 12/08/2005
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
Updated on 17/06/2003 and displayed until 27/09/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Acetylcysteine