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Abbott Healthcare Products Limited
2.1 Woodford Business Park, Santry, Dublin 9, Ireland
Telephone: +353 1 8468793
Fax: +353 1 8468701
Medical Information Direct Line: +44 (0)2380 467 000
Medical Information e-mail: medinfo.shl@abbott.com
Medical Information Facsimile: +44 (0)2380 467052
Summary of Product Characteristics last updated on medicines.ie: 05/09/2011
SPC Duphaston 10mg Film-Coated Tablets

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 05/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   29-Aug-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Removal of the Solvay logo 'S' embossed on the film coated tablets
Updated on 05/04/2011 and displayed until 05/09/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Mar-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 7

 

The following has been updated as highlighted;

 

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom
Updated on 03/09/2009 and displayed until 05/04/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   26-Feb-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
The changes are as follows:

- Update section 4.6 with a contraindication for known or suspected progesterone dependant neoplasma and as a consequence update section 4.8 of the SPc.

- Update section 4.4 of the SPC with additional information about caution for use in patient with liver function problems.

- Update section 4.6 and as a consequence section 5.3 of the SPC with information relating to the use in pregnant and lactating patients.

- Update the medical sections (4.2, 4.5, 4.7, 4.9 and 5.1) to be in line with SPC guidelines.

- Update the pharmaceuticals sections (2, 6.4, 6.6) in line with SPC guidelines.
Updated on 05/04/2007 and displayed until 03/09/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/02/2006 and displayed until 05/04/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Updated on 08/08/2005 and displayed until 24/02/2006
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 6.1 - List of excipients
Updated on 25/11/2004 and displayed until 08/08/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Updated on 26/06/2003 and displayed until 25/11/2004
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Dydrogesterone