Vincristine Sulphate 1 mg/ml Solution for Injection or Infusion
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal 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 gxVC 12_0 (1mg-ml) 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 gxVC 21_0 (1mg-ml) IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 13 November 2023
File name
Reg PIL gxVC 19_0 1mgml IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 November 2023
File name
Reg PIL gxVC 19_0 1mgml IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 September 2023
File name
Reg SPC gxVC 10_1 1mgml IE clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 September 2023
File name
Reg PIL gxVC 18_1 1 mg ml IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 23 September 2022
File name
RegSPCgxVC811mgmlIEClean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 September 2022
File name
RegPILgxVC1611mgmlIEclean.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 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 30 June 2022
File name
Reg PIL gx VC 15_0 1mg ml IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 30 June 2022
File name
Reg SPC gx VC 60_1 mg ml IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 May 2022
File name
Reg PIL gxVC 11_1 (1mg-ml) IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 01 November 2021
File name
Reg SPC gxVC 4_3 (1mg-ml) IE-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Sections 4.2 and 4.4 have been updated to align with the CDS in respect of administration instructions and avoidance of potential fatal medication errors.
Scetion 6.2 and 6.6 have been updated to refer to compatible diluents. Section 6.6 also includes a recommendation to label infusion bags for intravenous use only, fatal if given by other routes.
Updated on 01 November 2021
File name
Reg PIL gxVC 8_3 (1mg-ml) IE-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 31 August 2021
File name
Reg PIL gxVC 7_0 (1mg-ml) IE-clean.pdf
Reasons for updating
- 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 12 February 2021
File name
DEC202109384_Reg PIL gxVC 6_0 (1mg-ml) 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 19 January 2021
File name
DEC202103146_Reg SPC gxVC 3_3 (1mg-ml) IE-clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 January 2021
File name
DEC202103146_Reg PIL gxVC 5_1 (1mg-ml) IE-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 04 May 2020
File name
DEC202028791_Reg PIL gxVC 4_1 (1mg-ml) IE-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 22 November 2018
File name
Reg PIL gxVC 3_0 (1mg-ml) IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 02 November 2018
File name
Reg PIL gxVC 2_2 (1mg-ml) IE clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to name of medicinal product
- Correction of spelling/typing errors
Updated on 02 November 2018
File name
Reg SPC gxVC 2_2 (1mg-ml) IE clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Please update medicines.ie
SmPC section 1 – product name changed ‘Vincristine Sulfate 1 mg/ml solution for injection or infusion’
SmPC sections 2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1,5.2, 5.3, 6.2, 6.5 – QRD updates
SmPC section 10 – revision date
Updated on 05 October 2018
File name
Reg PIL gxVC 2_0 (1mg-ml) IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 05 October 2018
File name
Reg SPC gxVC 2_0 (1mg-ml) IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number
Updated on 11 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 September 2017
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Existing SPC re-submitted - Active ingredient on system updated to Vincristine Sulfate (previously listed incorrectly as Vincristine)
Updated on 07 September 2017
File name
PIL_17115_456.pdf
Reasons for updating
- New PIL for new product
Updated on 07 September 2017
Reasons for updating
- Correction of spelling/typing errors
Updated on 13 March 2017
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 March 2017
Reasons for updating
- New PIL for medicines.ie