VELETRI 0.5 mg, Powder for Solution for Infusion
*Company:
Janssen Sciences IrelandStatus:
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 21 October 2022
File name
PI-Veletri-0.5 mg-POW-Ireland-English-WS 650-Update instructions for use_EDMS-RIM-65403_6.0.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 21 October 2022
File name
PIL-Veletri-POW-Ireland-English-WS 650-Update instructions for use_EDMS-RIM-387805_7.0.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change of special precautions for disposal
- Change to dosage and administration
Updated on 13 August 2021
File name
IRE-Veletri-0.5mg SmPC C04 Clean 09Aug21 EDMS-RIM-65403 V4.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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)
Free text change information supplied by the pharmaceutical company
Alignment with EU Excipients guideline (sodium statement).
Updated on 13 August 2021
File name
IRE-Veletri 0.5mg and 1.5mg-PIL C04 clean 09Aug21 EDMS-RIM-387805 V5.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Alignment with EU Excipients guideline (sodium statement). Change to manufacturing site responsible for finished product batch release.
Updated on 20 July 2021
File name
IRE-Veletri-0.5mg and 1.5mg-PIL C03 Clean 14 July 21.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change manufacturing site responsible for batch release
Updated on 16 May 2020
File name
IRE-Veletri-0.5mg PIL C02 clean 11May20.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
change to batch release site.
Updated on 13 May 2020
File name
IRE-Veletri-0.5mg SmPC C02 clean 11May20.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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)
Free text change information supplied by the pharmaceutical company
Editorial changes and addition of date of license renewal.
Updated on 13 May 2020
File name
IRE Veletri 0.5 mg PIL C01_clean 20 Feb 2020.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to batch release site
Updated on 03 April 2020
File name
IRE Veletri 0.5 mg SmPC C02_Clean 3 April 2020.pdf
Reasons for updating
- 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
Correction to marketing authorisation number
Updated on 21 February 2020
File name
IRE Veletri 0.5 mg SmPC C01_Clean 20 Feb 2020.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Addition of new pump CADD Solis VIP
Updated on 21 February 2020
File name
IRE Veletri 0.5 mg PIL C01_clean 20 Feb 2020.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Addition of new pump CADD Solis VIP.
Updated on 30 October 2019
File name
Veletri 0.5 mg PIL_Dec 2018_Ireland.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 30 October 2019
File name
Veletri 0.5 mg SmPC_Dec 2018_Ireland.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 November 2018
File name
Veletri 0.5 mg PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 27 July 2018
File name
IRL Veletri SmPC 0.5mg.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 June 2018
File name
Veletri PIL 0.5mg, 1.5mg.docx
Reasons for updating
- 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
Cardiac Disorders: High output cardica failure (Unknown)
Updated on 21 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 February 2018
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
Updated on 21 February 2018
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 20 February 2018
File name
PIL_17168_521.pdf
Reasons for updating
- New PIL for new product
Updated on 01 June 2017
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 01 June 2017
Reasons for updating
- New SPC for medicines.ie