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Helsinn Birex Therapeutics Ltd
Damastown, Mulhuddart, Dublin 15,
Telephone: +353 1 8225417
Fax: +353 1 8225413
Medical Information e-mail: info@helsinn.com
Summary of Product Characteristics last updated on medicines.ie: 23/07/2010
SPC ByFluc 150mg 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 23/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   25-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Included:
2.             QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule also contains lactose monohydrate 141mg
Updated on 25/08/2009 and displayed until 23/07/2010
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:   01-May-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 7:  Change in MA holder from Ergha Healthcare Ltd. to Helsinn Birex Therapeutics Ltd.

Section 8 - change in MA numbers from PA 966/8/2   to PA 915/28/2
Updated on 10/08/2005 and displayed until 25/08/2009
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Fluconazole