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

*
Pharmacy Only: Prescription

  • Company:

    Servier Laboratories Ireland Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to restricted prescription (C)

  • Active Ingredient(s):

    Pegaspargase

    This medicinal product is subject to additional monitoring.

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

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Updated on 31 July 2024

File name

ema-combined-h-3789 PIL_cl VOD_clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 31 July 2024

File name

ema-combined-h-3789 SmPC_cl VOD_clean.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 20 October 2022

File name

Oncaspar PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 19 September 2022

File name

Oncaspar SmPC.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 19 September 2022

File name

Oncaspar PIL.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 28 February 2022

File name

Oncaspar PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 21 February 2022

File name

Oncaspar SPC.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 21 February 2022

File name

Oncaspar PIL.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 08 March 2021

File name

SmPC Oncaspar.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.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.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.pdf

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 19 May 2020

File name

Oncaspar powder for solution.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.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.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.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.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.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.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.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 January 2019

File name

SmPC lyo.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

Servier Laboratories Ireland Ltd

Servier Laboratories Ireland Ltd