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Detrusitol SR 2 mg, prolonged-release, hard;

  • Name:

    Detrusitol SR 2 mg, prolonged-release, hard;

  • Company:
    info
  • Active Ingredients:

    Tolterodine tartrate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/07/15

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Summary of Product Characteristics last updated on medicines.ie: 31/7/2015
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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 231 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 31 July 2015

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 31 July 2015 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



The SPC has been updated as follows.

Section 4.8 Reporting of suspected adverse reactions – QRD text added.

Updated on 28 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 July 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 17 February 2012 PIL

Reasons for updating

  • PIL re-instated

Updated on 23 January 2012 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 7 - updated with Pfizer Healthcare Ireland; Section 8 - updated with new PA number

Updated on 21 October 2011 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC MAH name change from Pharmacia Ireland Limited to Pharmacia Ireland

Updated on 18 October 2011 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 27 September 2011 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 November 2010 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC (Section 6.5 Pack size amended to refer number of units instead of number of blisters)

Updated on 8 November 2010 PIL

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 29 July 2010 PIL

Reasons for updating

  • Change of manufacturer

Updated on 18 February 2009 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 11 December 2008 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated to include the most common side effects with the tabulated listing.

Updated on 10 December 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 15 July 2008 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Nature of changes:
Section 4.5 has been updated to include an additional CYP2D6 enzyme.
Section 4.8 has been update to add a number of additional side effects.

Updated on 15 July 2008 PIL

Reasons for updating

  • Change to drug interactions
  • Change to side-effects

Updated on 7 December 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 7 December 2007 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

7.0 – Marketing Authorisation Holder (Address)

Updated on 14 June 2007 PIL

Reasons for updating

  • Change to side-effects

Updated on 14 June 2007 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8 – Revision of section to more closely align with the core data sheet

Updated on 20 April 2007 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 17 April 2007 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

Section 2 addition of wording to increase clarity

Section 4.2 amended wording regarding paediatric use

Section 4.5 minor grammatical change to text

Section 4.8 inclusion of text on experience with paediatric use

Section 4.9 minor grammatical change to text 

Section 5.1 inclusion of text on experience with paediatric use

Section 5.2 inclusion of text on experience with paediatric use

Section 6.6 Update in line with current EU guidelines

Updated on 28 November 2005 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 11 November 2005 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 12 August 2005 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 22 September 2004 SPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 July 2004 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 July 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)