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VFEND 200 mg powder and solvent for solution for infusion

  • Name:

    VFEND 200 mg powder and solvent for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Voriconazole

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/03/21

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Summary of Product Characteristics last updated on medicines.ie: 25/3/2021

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Pfizer Healthcare Ireland

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1 - 0 of 233 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 25 March 2021 SPC

Reasons for updating

  • 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 not be renewed (A)

Updated on 25 March 2021 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 14 October 2020 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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

Updated on 14 October 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 20 August 2020 SPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Update to section 4.5 regarding the interaction between voriconazole and letermovir & tolvaptan. 
The AE reporting details for the HPRA have been updated in line with the new truncated wording
Separate UK and IE SPCs have been created as part of the Brexit split pack project. Both UK and IE SPCs contain the updates to section 4.5

Please note that the Powder and solvent for solution for infusion licence is not marketed in UK or IE and so has not been separated into a separate UK and IE SPC. The updated joint UK and IE SPC will therefore be added to the EMC/Medicines.ie and maintained until the expiry date of the last batch has passed.

Updated on 20 August 2020 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 12 April 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 April 2019 SPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 18 December 2018 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4 and 4.8 – addition of DRESS

Updated on 31 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 31 October 2018 SPC

Reasons for updating

  • 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

 

The SPC has been updated as follows:

  • Section 10: DATE OF REVISION OF THE TEXT has been updated

Updated on 11 October 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 11 October 2018 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 7 - MA transfer from Pfizer Limited Sandwich to Pfizer Europe MA EEIG Bruxelles.

Section 4.8 – UK Adverse Event reporting information is updated

Updated on 30 August 2018 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: SmPC sections 6.5 and 8 updated to introduce new blister type following addition of Ascoli and, as a result, new EU MA numbers.

Updated on 11 June 2018 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: SmPC sections 6.5 and 8 updated to introduce new blister type following addition of Ascoli and, as a result, new EU MA numbers.

Updated on 5 June 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 3 March 2017 PIL

Reasons for updating

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

Updated on 3 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 June 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 18 December 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 25 June 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 8 October 2014 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 4 September 2014 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 August 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 1 July 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Changes to therapeutic indications

Updated on 25 February 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 21 February 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 3 December 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 1 August 2013 PIL

Reasons for updating

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

Updated on 12 November 2012 PIL

Reasons for updating

  • New PIL for medicines.ie