Oncaspar 750 U/ml powder for solution for injection/infusion
*Company:
Servier Laboratories Ireland LtdStatus:
UpdatedLegal 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
Updated on 13 May 2026
File name
Ireland SPC-3789 Final 30.04Clean.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated to remove NI details in product information due to the Windsor Framework.
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
Address:
1st Floor, Building Two, The Green Dublin Airport Central , Dublin Airport, Swords, Co. Dublin, K67 E2H3Medical Information E-mail:
medicalinformation-dublin@servier.comTelephone:
+353 1 663 8110Fax:
+353 1 663 8120