Valcyte 50mg/ml Powder for Oral Solution
- Name:
Valcyte 50mg/ml Powder for Oral Solution
- Company:
Roche Products (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/01/21
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Roche Products (Ireland) Ltd
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| Medicine Name Madopar 50mg/12.5mg, 100mg/25mg Dispersible Tablets | Active Ingredients Benserazide Hydrochloride, Levodopa |
| Medicine Name Pulmozyme 2500 U/2.5ml Nebuliser Solution | Active Ingredients Dornase Alfa |
| Medicine Name Rivotril 0.5mg Tablets | Active Ingredients Clonazepam |
| Medicine Name Roaccutane 10mg Soft Capsules | Active Ingredients Isotretinoin |
| Medicine Name Roaccutane 20mg Soft Capsules | Active Ingredients Isotretinoin |
| Medicine Name Rocephin 1g Powder and Solvent for IM Injection Only | Active Ingredients Ceftriaxone sodium |
| Medicine Name Rocephin 1g Powder for Solution for Injection or Infusion | Active Ingredients Ceftriaxone sodium |
| Medicine Name Valcyte 450 mg Film-coated Tablets | Active Ingredients valganciclovir hydrochloride |
| Medicine Name Valcyte 50mg/ml Powder for Oral Solution | Active Ingredients valganciclovir hydrochloride |
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 11 January 2021 SPC
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 PIL
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 SPC
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 PIL
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 PIL
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 29 August 2018 SPC
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 PIL
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 15 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 10 April 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 21 August 2014 PIL
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 4 July 2013 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 21 December 2011 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 28 July 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to how the medicine works
Updated on 21 July 2010 PIL
Reasons for updating
- Change to dosage and administration
Updated on 5 March 2010 PIL
Reasons for updating
- New PIL for new product