Oncaspar 750 U/ml powder for solution for injection/infusion *

  • Company:

    Servier Laboratories Ireland Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to restricted prescription (C)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 08 March 2021

File name

SmPC Oncaspar_1615201136.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

Legal category:Product subject to restricted prescription (C)

Updated on 26 November 2020

File name

Oncaspar SmPC_1606403819.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

Legal category:Product subject to restricted prescription (C)

Updated on 26 November 2020

File name

Oncaspar PIL_1606403764.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 20 May 2020

File name

PIL Oncaspar powder for solution_1589960281.pdf

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 19 May 2020

File name

Oncaspar powder for solution_1589882393.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • 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 06 May 2020

File name

SmPC Oncaspar powder for solution for injection_1588759218.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 17 February 2020

File name

SmPC Oncaspar LYO_1581928153.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to restricted prescription (C)

Updated on 03 October 2019

File name

Oncaspar Lyophilisate SMPC_1570112619.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to restricted prescription (C)

Updated on 03 October 2019

File name

Oncaspar Lyophilisate PIL_1570112568.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents

Updated on 03 October 2019

File name

SmPC ONCASPAR Lyo_1570112404.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to restricted prescription (C)

Updated on 03 October 2019

File name

Oncaspar lyo PIL_1570112350.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents

Updated on 07 January 2019

File name

PIL lyo_1546872908.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 January 2019

File name

SmPC lyo_1546872967.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)