Noxafil 300 mg concentrate for solution for infusion

  • Name:

    Noxafil 300 mg concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Posaconazole

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/11/19

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Summary of Product Characteristics last updated on medicines.ie: 13/11/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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1 - 0 of 81 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 13 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Changes to Section 2, Section 4 and Section 6

Updated on 13 November 2019 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8: Tabulated list of adverse reactions is updated & Section 10- Date of revision of test is updated

Updated on 25 July 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 23 July 2018 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to section 7. Marketing Authorisation Holder and Section 10 – Date of revision of the text following approval of MA Transfer

Updated on 26 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 May 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 23 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 May 2017 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC change details: Updates to sections 4.4, 4.5, and 10 as a result of approval of Type II variation EMEA/H/C/000610/II/0048 to strengthen language on drug-drug interaction for azole antifungals, including posaconazole, with vincristine

Updated on 30 September 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 28 September 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Reasons for submission: Approval of EMEA/H/C/000610/IB/0046 (Add information on sodium content)

Updated on 10 May 2016 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 1 September 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 24 August 2015 SmPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.6 – Special Precautions for disposal and handling and Change to Section 10 – Date of revision
Reasons for submission: Approval of EMEA/H/C/000610/II/0036

Updated on 28 April 2015 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 27 April 2015 PIL

Reasons for updating

  • New PIL for medicines.ie