Valcyte 50 mg/ml Powder for Oral Solution *
Pharmacy Only: Prescription

Updated on 26 August 2021

File name

PIL Valcyte_POS_Art 61.3_23Aug2021_Clean_1629996366.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 11 January 2021

File name

Irish SPC Valcyte Syrup_V7.0_IB-078_30-Dec-2020_Clean_1610383642.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Updated inline with QRD template and/or excipient guideline

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

Updated on 11 January 2021

File name

Irish PIL Valcyte Syrup_V7.0_IB-078_30-Dec-202_clean_1610383563.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change of licence holder
  • Change to improve clarity and readability

Updated on 22 June 2020

File name

Valcyte_SmPC_IB-075_15-Jun-2020_Clean_1592825590.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • 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

NL/H/0323/002/IB/075 POS dispenser change (mg to ml) Powder for oral solution: Update for new dispenser and addition of mg to mL conversion table. Updates to SmPC and leaflet including IFU.

Updated on 22 June 2020

File name

Valcyte_PIL_IB-075_15-Jun-2020_clean_1592825416.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

NL/H/0323/002/IB/075 POS dispenser change (mg to ml) Powder for oral solution: Update for new dispenser and addition of mg to mL conversion table. Updates to SmPC and leaflet including IFU.

Updated on 14 April 2020

File name

PIL_Valcyte_POS_Art61.3_30-Mar-2020_clean_1586873134.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

NL/H/0323/001-002/P/003 - Valcyte FCT and POS. The changes  in this notification were:
1. Roche no longer holds a Marketing Authorisation for Valcyte film-coated tablets (FCT) in Malta, Romania and Slovak Republic therefore references to these countries were removed from the FCT patient information leaflet.2. Roche no longer holds a Marketing Authorisation for Valcyte powder for oral solution (POS) in Bulgaria, Malta, Romania and Slovak Republic therefore  references to these countries were removed from the POS patient information leaflet. 

Updated on 29 August 2018

File name

ie-pil-Valcyte-clean-180628-50mg-pos_1535543493.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 29 August 2018

File name

ie-spc-valcyte-clean-180628-50mg-pos_1535543545.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

MAH Transfer from RPL to Roche Products (Ireland) Limited issue of new PA licence number(s).

Updated on 15 November 2017

File name

PIL_14606_865.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 November 2017

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 2 - pregnancy, breast feeding and fertility
  • 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 10 April 2015

Reasons for updating

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

Updated on 21 August 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Addition of information on reporting a side effect.

Updated on 04 July 2013

Reasons for updating

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

Updated on 21 December 2011

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 28 July 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to how the medicine works

Updated on 21 July 2010

Reasons for updating

  • Change to dosage and administration

Updated on 05 March 2010

Reasons for updating

  • New PIL for new product