Valcyte 50 mg/ml Powder for Oral Solution * Pharmacy Only: Prescription
Company:
Roche Products (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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