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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 40 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 891/15/3
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
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 11/09/2009 and displayed until 03/11/2009
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 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Aug-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 to the product name to include the strength units, in line with the same changes that were agreed during the renewal of the 10 and 20 mcg/ml products;

Section 2: Updated cross reference to excipients section;

Section 3: Updated description of product;

Section 6.2: Inclusion of warning not to mix this product with any other medicinal products;

Section 6.4: Expanded storage advice of keeping the product in the original package in order to protect it from light;

Section 6.5: Standard statement added that not all pack sizes may be marketed;

Section 6.6: Disposal instructions for needle and cartridge added, in addition to updating section heading in line with SmPC guideline;

Sections 9 & 10: Updated to reflect approval dates of the last licence renewal.
Updated on 22/09/2008 and displayed until 11/09/2009
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   05/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 10: Correction of last revision date
Updated on 23/08/2007 and displayed until 22/09/2008
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 11/04/2006 and displayed until 30/08/2006
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Updated on 28/09/2005 and displayed until 11/04/2006
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
Updated on 27/09/2005 and displayed until 28/09/2005
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 10 - Date of revision of the text
Updated on 18/02/2004 and displayed until 27/09/2005
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 27/10/2003 and displayed until 18/02/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 30/06/2003 and displayed until 27/10/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Alprostadil