Oncaspar 750 U/ml powder for solution for injection/infusion
*Company:
Servier Laboratories Ireland LtdStatus:
No Recent UpdateLegal 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 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)