Arelix Tablets 6mg

  • Name:

    Arelix Tablets 6mg

  • Company:
    info
  • Active Ingredients:

    Piretanide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/05/15

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 15/3/2017
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Medicine Name Arelix Tablets 6mg Active Ingredients Piretanide
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1 - 0 of 176 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 15 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 15 March 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Type II.C.1.4 – Update SmPC to align with Piretanide CCSIv2

Updated on 15 May 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 May 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 5 June 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 5 March 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3: shelf-life reduced from 5 years to 3 years

Updated on 2 September 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 2 September 2011 SmPC

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Improved presentation

Updated on 19 August 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Addition of statement re breakability of tablet.

Updated on 21 December 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 16 September 2010 SmPC

Reasons for updating

  • 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 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

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

Free text change information supplied by the pharmaceutical company

Changes made to above sections to bring SPC in line with the core SPC.

Updated on 20 May 2010 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Administrative changes.

Updated on 19 May 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 August 2009 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 24 July 2008 SmPC

Reasons for updating

  • 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

Update section 10 Date of Revision

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2006 SmPC

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

Update Section
7 - Change MAH to sanofi-aventis Ireland Ltd.
10 - Date of Revision

Updated on 13 April 2006 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 9 - Date of renewal of authorisation

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

Updated on 4 April 2006 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

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

Updated on 12 January 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 14 November 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 14 December 2004 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 February 2004 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 18 September 2003 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Updated on 5 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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