VELETRI 0.5 mg, Powder for Solution for Infusion *
Pharmacy Only: Prescription

  • Company:

    Janssen-Cilag International NV
  • Status:

    No Recent Update
  • Legal 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

6352adefec708.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

6352ab8678c46.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_1628892053.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_1628891771.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_1626801519.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_1589633663.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_1589407095.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_1582325706.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_1585942282.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_1582326864.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_1582325706.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_1572459840.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_1572459282.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_1542807199.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_1532697713.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

DATE OF REVISION OF THE TEXT

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

DATE OF REVISION OF THE TEXT

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

None provided

Updated on 01 June 2017

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided