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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Fax: +353 1 294 5104
Medical Information e-mail: info@mundipharma.ie
Summary of Product Characteristics last updated on medicines.ie: 21/07/2011
SPC Codalax and Codalax Forte Capsules

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 21/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-May-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2 - Deleted "Excipient: The printing ink contains a trace amount of soyal oil.

Section 4.3 - Deleted "Peanut or soyal allergies"

Section 7.  Marketing Authorisation Holder is now 

Mundipharma Pharmaceuticals Limited

Millbank House

Arkle Road

Sandyford

Dublin 18

Section 8 - MA Numbers have changed  now reads CODALAX capsules   PA 1688/3/1
                                                                                   CODALAX forte capsules PA 1688/3/2
Updated on 23/08/2009 and displayed until 21/07/2011
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   14-Nov-2008
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
correct SPC uploaded
Updated on 01/09/2003 and displayed until 23/08/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • 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
Updated on 23/06/2003 and displayed until 01/09/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Poloxamer 188
  Dantron