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VFEND 40mg/ml powder for oral suspension

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Voriconazole

    *Additional information is available within the SPC or upon request to the company

Updated on 09 April 2024

File name

Adv SPC VF 59_0 IEclean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Updated on 09 April 2024

File name

Adv PIL VF 53_0 40mgml POS IE NI clean.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 09 November 2023

File name

Adv SPC VF 58_0 IE clean.pdf

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)

Updated on 09 November 2023

File name

Adv PIL VF 52_0 40mgml Powder Oral Susp IE NI clean.pdf

Reasons for updating

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

Updated on 12 October 2023

File name

Adv SPC VF 57_1 IE clean.pdf

Reasons for updating

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

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

Updated on 12 October 2023

File name

Adv PIL VF 51_1 40 mgml Powder Oral Susp IE NI clean.pdf

Reasons for updating

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

Updated on 07 June 2023

File name

Adv SPC VF 560 IE clean.pdf

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)

Updated on 07 June 2023

File name

Adv PIL VF 500 40mg ml Powder Oral Susp IE NI clean.pdf

Reasons for updating

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

Updated on 14 June 2022

File name

Adv PIL VF 49_0 40mgml Powder Oral Susp IE & NI - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

The PIL IE has been updated to include:

  • Malta ADR reporting
  • Malta Local Representative information


Updated on 10 May 2022

File name

AdvSPCVF550IEclean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 13 January 2022

File name

Adv SPC VF 54_0 IE - clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

The SPC IE and SPC NI have been updated as follows:

Update of sections 4.4 and 4.8 of the SmPC to include cutaneous SCC, or Bowen’s disease in order to reinforce physicians’ level of awareness of this voriconazole-associated risk.

Section 4.4
Addition of “(including cutaneous SCC in situ, or Bowen’s disease)” to information on Squamous cell carcinoma of the skin (SCC)

Section 4.8
Addition of “(including cutaneous SCC in situ, or Bowen’s disease)” to information on Squamous cell carcinoma of the skin (SCC) in the ADR table

The PIL is not affected.

Updated on 12 January 2022

File name

Adv PIL VF 48_0 40mgml Powder Oral Susp IE & NI - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section
  • Individual PILs superseded by joint PIL

Updated on 26 October 2021

File name

Adv SPC VF 53_0 IE - clean.pdf

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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.3 Contraindications:

- Addition of naloxegol, tolvaptan and lurasidone (following review concerning the classification of voriconazole as a strong CYP3A4 inhibitor);

- Change in position of existing information on coadministration with St John’s Wort.

Section 4.4 Special warnings and precautions for use:

- Addition of clarifying text regarding adrenal insufficiency and Cushing’s syndrome;

- Deletion of text on coadministration of naloxegol from Section 4.4 (Consequential to its addition to Section 4.3).

Section 4.5 Interaction with other medicinal products and other forms of interaction:

- Addition of the DDI with lurasidone

- Change in position of information on naloxegol, tolvaptan and everolimus (Interactions table)

- Addition of clarification text to the recommendations for statins and addition of midazolam PK DDI data

Updated on 26 October 2021

File name

Adv PIL VF 44_0 40mgml Powder Oral Susp IE - clean.pdf

Reasons for updating

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

Updated on 13 October 2021

File name

Adv PIL VF 43_0 40mgml Powder Oral Susp IE - clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 13 October 2021

File name

Adv SPC VF 52_0 IE - clean.pdf

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

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

Update to Section 4.4 Special warnings and precautions for use - addition of glasdegib and tyrosine kinase inhibitors

 

Section 4.5

Update to Section 4.5 Interaction with other medicinal products and other forms of interaction - addition of glasdegib, tretinoin and tyrosine kinase inhibitors metabolised by CYP3A4.

 

Updated on 26 March 2021

File name

DEC202119666_Adv PIL VF 42_0 40mgml Powder Oral Susp IE - clean.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

File name

DEC202119666_Adv SPC VF 51_0 IE - clean.pdf

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

File name

DEC202119666_Adv PIL VF 42_0 40mgml Powder Oral Susp IE - clean.pdf

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

File name

DEC202066872_Adv SPC VF 50_0 IE-clean.pdf

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

File name

DEC202066872_Adv PIL VF 41_0 40mgml Powder Oral Susp IE-clean.pdf

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

File name

DEC202050224_Adv SPC VF 49_0 IE-clean.pdf

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

File name

DEC202050224_Adv PIL VF 40_0 40mgml Powder Oral Susp IE-clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 05 December 2019

File name

DEC201968083_Adv PIL VF 38_0 40mgml Powder Oral Susp UK & IE_clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 April 2019

File name

DEC201919269_Adv PIL VF 37_0 40mgml Powder Oral Susp UK & IE_clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 April 2019

File name

DEC201919269_Adv SPC VF 47_0 UK & IE_clean.pdf

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

File name

Adv SPC VF 46_0 UK & IE clean.pdf

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

File name

Adv PIL VF 36_0 40mgml Powder Oral Susp UK & IE.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 31 October 2018

File name

Adv SPC VF 45_0 UK & IE.pdf

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

File name

Adv PIL VF 35_0 40mgml Powder Oral Susp UK IE.pdf

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

File name

Adv SPC VF 44_0 UK IE.pdf

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

File name

Adv_SPC_VF_43_0_UK_&_IE_clean.pdf

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

File name

Adv_SPC_VF_43_0_UK_&_IE_clean.docx

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 05 June 2018

File name

Vfend VF 42_0.docx

Reasons for updating

  • New SPC for new product

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

Updated on 03 March 2017

File name

PIL_9862_984.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 March 2017

Reasons for updating

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

Updated on 21 June 2016

Reasons for updating

  • Change to date of revision

Updated on 18 December 2015

Reasons for updating

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

Updated on 22 September 2015

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 25 June 2015

Reasons for updating

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

Updated on 08 October 2014

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 04 September 2014

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 August 2014

Reasons for updating

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

Updated on 01 July 2014

Reasons for updating

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

Updated on 25 February 2014

Reasons for updating

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

Updated on 21 February 2014

Reasons for updating

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

Updated on 03 December 2013

Reasons for updating

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

Updated on 01 August 2013

Reasons for updating

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

Updated on 10 January 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

Updated on 28 February 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 09 January 2012

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • Change to dosage and administration

Updated on 13 September 2011

Reasons for updating

  • Change to drug interactions

Updated on 17 January 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions

Updated on 14 September 2010

Reasons for updating

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

Updated on 25 February 2009

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 07 May 2008

Reasons for updating

  • Improved electronic presentation

Updated on 20 February 2008

Reasons for updating

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

Updated on 01 August 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 14 June 2007

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Improved electronic presentation
  • Change to dosage and administration
  • Change of special precautions for disposal

Updated on 07 August 2006

Reasons for updating

  • Change to drug interactions

Updated on 01 August 2006

Reasons for updating

  • Change to drug interactions

Updated on 01 March 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to dosage and administration
  • Change to side-effects

Updated on 01 June 2005

Reasons for updating

  • New PIL for medicines.ie