Cytarabine 100 mg/ml Solution for Injection
*Company:
Pfizer Healthcare IrelandStatus:
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 14 December 2023
File name
Reg PIL gxCY 11_0 100 mgml inj IEclean.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 13 February 2023
File name
DEC202126497_Reg SPC gxCY 5_1 100mg-ml inj IE_clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 April 2021
File name
DEC202126497_Reg SPC gxCY 5_1 100mg-ml inj IE_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
The SPC has been updated as follows: Section 2 – Excipient update regarding sodium (20 mg/ml only) Section 4.4 – Update concerning excipient information for sodium Section 4.8 – Update to AE Reporting details Section 10 – Revised date of revision
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Updated on 20 April 2021
File name
DEC202126497_Reg PIL gxCY 7_1 100mg-ml inj IE_clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 22 June 2020
File name
DEC202041589_Reg PIL gxCY 5_1 100mg-ml inj 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 31 October 2018
File name
Reg PIL gxCY 4_0 100mg-ml inj IE_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 October 2018
File name
Reg PIL gxCY 3_0 100mg-ml inj 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 05 October 2018
File name
Reg SPC gxCY 3_1 100mg-ml inj 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 28 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 November 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
100mg/ml SPC update:
Section 2: QRD update
Section 4.1: changed the title by making the ‘I’ in indications a capital
Section 4.2: QRD updates
Section 4.3: QRD updates
Section 4.4: QRD updates
Section 4.6: QRD updates
Section 4.8: add side-effect ‘sinus bradycardia’
Section 5.1: QRD updates
Section 5.2: QRD updates
Section 6.4: v minor font update
Section 6.6: QRD updates
Section 10: QRD heading update and new revision date.
Updated on 23 November 2017
File name
PIL_16942_227.pdf
Reasons for updating
- New PIL for new product
Updated on 23 November 2017
Reasons for updating
- 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 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Improved presentation of PIL
Updated on 06 October 2016
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 06 October 2016
Reasons for updating
- New PIL for medicines.ie