Cisplatin 1 mg/ml Concentrate for Solution for Infusion (Latex-free vial stopper)
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal 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 16 October 2024
File name
Reg SPC gxCP 15_0 IE_clean.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 16 October 2024
File name
Reg PIL gxCP 16_0 IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 09 September 2024
File name
Reg SPC gxCP 14_2 IE_clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
- 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 09 September 2024
File name
Reg PIL gxCP 15_1 IE_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 06 December 2023
File name
Reg PIL gx CP 13 0 IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 March 2023
File name
Reg SPC gxCP 12_1 IE clean.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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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 17 March 2023
File name
Reg PIL gx CP 12_1 IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 06 September 2022
File name
RegSPCgxCP101IEclean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC is has been updated as follows:
Section 4.4 – Removal of warning statement that the vial stopper contains dry natural rubber (latex).
Section 10 – Date of Revision
This product is the same as the existing Cisplatin on medicines.ie but has a Latex-free vial stopper
Updated on 06 September 2022
File name
RegPILgxCP111IEclean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
This is the same as the existing Cisplatin listed on medicines.ie but has a Latex-free vial stopper