Zoledronic acid 4 mg/5 ml concentrate for solution for infusion (plastic vial)

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 23 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 November 2017 SmPC

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

$0SmPC updated to reflect HPRA approval for Type IBMRP variation (approved 6Nov2017) to update sections 4.4 and 4.8 in-line withthe reference product (Zometa) as regards osteonecrosis of other anatomicalsites (i.e. sites other than the jaw). Corresponding changes made to the PIL (section4).$0

Updated on 20 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 November 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 2 August 2017 SmPC

Reasons for updating

  • 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 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 (sections 4.4, 4.8 and 4.9) and PIL revised via Type IB safety variation (to adopt agreed CHMP wording). Approved 14Jul2017.

Updated on 31 July 2017 PIL

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 1 October 2015 SmPC

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 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

To update sections 4.2, 4.4 and 4.8 of the Intrapharm Zoledronic acid SmPC (Type IB MRP variation approved in Ireland 24Sep2015) to reflect the current knowledge on osteonecrosis of the jaw (ONJ) following CHMP opinion (in relation to Zometa). Consequently, the Intrapharm PIL (also approved by HPRA 24Sep2015) has been updated. Patient alert card (being) implemented as a consequence.

Updated on 1 October 2015 PIL

Reasons for updating

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

Updated on 21 May 2015 SmPC

Reasons for 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 sections 4.4, 4.5, 4.6, 4.8 and 5.2 revised via MRP Type IB variation approved by HPRA on 12May2015 (alignment with reference product). PIL updated as a consequence.

Updated on 15 May 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 20 August 2014 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

medicines.ie SmPC updated to reflect 5Aug2014 IMB e-mail approval forvariation to extend finished product shelf-life from 24 to 36 months.

Updated on 18 April 2014 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 14 April 2014 PIL

Reasons for updating

  • New PIL for new product