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Galen Ireland

Seagoe Industrial Estate, Craigavon, BT63 5UA, Ireland
Telephone: 0483 833 4974
Fax: 0483 835 0206
E-mail: customer.services@galen-pharma.com
WWW: http://www.galen-pharma.com
Summary of Product Characteristics last updated on medicines.ie: 09/07/2012
SPC Laxido Orange, powder for oral solution

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 09/07/2012 and displayed until Current
Reasons for adding or updating:
  • 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 4.6 - 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:   22-Jun-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Sections 4.4, 4.5, 4.6, 4.8 and 5.3 updated.
Updated on 12/02/2009 and displayed until 09/07/2012
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • SPC retired pending re-submission
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company


Section 10:
  Date of revision updated
Updated on 12/02/2009 and displayed until 12/02/2009
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   02/2009
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 6.5  an additional pack size (100 sachet) has been added

Updated on 28/10/2008 and displayed until 12/02/2009
Reasons for adding or updating:
  • New SPC for new product

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