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UCB (Pharma) Ireland Limited
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Telephone: +353 1 463 7395
Fax: +353 1 463 7396
Medical Information Direct Line: +44 (0)1753 447 690
Medical Information e-mail: medicalinformationuk@ucb.com
Medical Information Facsimile: +44 (0)1753 447 858
Summary of Product Characteristics last updated on medicines.ie: 17/05/2012
SPC Viridal Duo 10 micrograms/ml, Powder and Solvent for Solution for Injection.

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 17/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   14-May-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Shelf life reduced to 36 months
Updated on 22/09/2010 and displayed until 17/05/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   13-Aug-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Change in PA holder name/address to UCB Pharma Ireland Ltd and PA number  PA 891/15/1
Updated on 03/11/2009 and displayed until 22/09/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
4.3:- use of standardised wording concerning hypersensitivity to the active substance or to any other ingredients;
4.4:- deletion of statement concerning diseases associated with prolonged erections that are already contraindicated in section 4.3;
- included greater detail for physicians in section on patients with blood clotting disorders;
4.6:- included information from CCDS re use during pregnancy and moved existing non-clinical data to section 5.3;
4.8:- re-ordered according to frequencies and organ class;
5.3:- included information that was previously listed in section 4.6.
Updated on 21/05/2009 and displayed until 03/11/2009
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   01-Mar-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 1: Update of product name
Section 2: Updated to include standard statement to cross-refer to section 6.1
Section 3: Updated to include additional information concerning pharmaceutical form in line with SmPC guideline
Section 6.2: Replaced "Not applicable" with clear statement that the product should not be mixed with other products.
Section 6.4: Storage statement expanded to include reason for storing in original package.
Section 6.5: "Not all pack sizes may be marketed" added.
Section 6.6: Heading updated and inclusion of disposal instructions for needles and cartridge added.
Sections 9 & 10: Updated to refelct licence renewal approval.
Updated on 23/08/2007 and displayed until 21/05/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 1 (trade name) - The word 'duo' has been inserted
Updated on 20/06/2007 and displayed until 23/08/2007
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.4 - Storage conditions added
Updated on 30/08/2006 and displayed until 20/06/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   05/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 7 (change of address) - the old Marketing Authorisation Holder address has been removed:
SCHWARZ PHARMA Limited
East Street
Chesham
Buckinghamshire, HP5 1DG
England 

 
It has been replaced by the new address for the Marketing Authorisation Holder which is:
SCHWARZ PHARMA Limited
5 Hercules Way
Leavesden Park
Watford
WD25 7GS
United Kingdom
Updated on 04/08/2005 and displayed until 30/08/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Change to section 6.4 - Special precautions for storage
Updated on 21/07/2005 and displayed until 04/08/2005
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
Updated on 08/04/2004 and displayed until 21/07/2005
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Updated on 18/02/2004 and displayed until 08/04/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Updated on 21/08/2003 and displayed until 18/02/2004
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 30/06/2003 and displayed until 21/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Alprostadil