Nivestim 12 MU/ 0.2 ml solution for injection/infusion, Nivestim 30 MU/ 0.5 ml solution for injection/infusion, Nivestim 48MU/ 0.5 ml solution for injection/infusion
*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 11 April 2024
File name
Adv SPC bNT 13_0 IE clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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 28 February 2024
File name
AdvSPCbNT120IEclean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
SPC has been updated as follows:
Section 4.4 – removal of warning for cytogenic abnormalities
Section 10 – Date of Revision
Updated on 25 May 2023
File name
AdvPILbNT160IENIclean (1).pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 17 January 2023
File name
AdvSPCbNT110IEclean.pdf
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 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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
SPC has been updated as follows:
Sections 2, 4.1, 4.2, 5.1, 5.3 and 6.6 – minor typographical changes and change from µg to mcg.
Section 4.4 – addition of information on Myelodysplastic Syndrome and AML
Section 4.8 – IE only – Adverse Event Reporting details amended
Updated on 17 January 2023
File name
AdvPILbNT150IENIclean.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 28 September 2022
File name
AdvPILbNT140IENIclean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 29 May 2020
File name
DEC202035112_Adv SPC bNT 10_0 IE_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Updated on 29 May 2020
File name
DEC202035112_Adv PIL bNT 11_0 UK & IE_clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 29 May 2020
File name
DEC202035112_Adv SPC bNT 10_0 IE_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Updated on 29 May 2020
File name
DEC202035112_Adv PIL bNT 11_0 UK & IE_clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 17 December 2019
File name
DEC201970885_Adv SPC bNT 9_0 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 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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
|
The SPC has been updated as follows: The major changes are for: Section 2: ‘Excipient with known effect’ additional reference for sorbitol and to section 4.4. Section 4.4: Sub-section for ‘Traceability’ added; Sub-section for ‘All patients’ has additional wording concerning hereditary fructose intolerance (HFI) for all patients, including babies and young children. Section 10: Revision date updated. Minor editorial/typographical changes to Sections1, 2, 4.1, 4.2, 4.4, 4.6, 4.8, 5.1, 5.3, 6.3, 6.4 & 6.5.
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Updated on 17 December 2019
File name
DEC201970885_Adv PIL bNT 10_0 UK & IE_clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Updated on 17 April 2019
File name
DEC201920331_Adv PIL bNT 8_0 UK & IE_clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 17 April 2019
File name
DEC201920331_Adv SPC bNT 8_0 IE_clean.pdf
Reasons for updating
- 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 10, date of revision has been updated to 12 April 2019.
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Updated on 04 January 2019
File name
Adv PIL bNT 7_0 UK IE_clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- 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 - 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 contains
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 20 November 2018
File name
Adv SPC bNT 7_0 IE_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: |
Updated on 11 September 2018
File name
Adv PIL bNT 6_0 UK IE_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 September 2018
File name
Adv SPC bNT 6_0 IE_clean.pdf
Reasons for updating
- 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 10 – Date of Revision updated to 07 September 2018
Updated on 30 August 2018
File name
Adv SPC bNT 5_1 IE_clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 7 – Change to Marketing Authorisation Holder
Section 10 – Date of Revision updated to 23 August 2018
Updated on 28 August 2018
File name
Adv PIL bNT 5_1 UK & IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 29 May 2018
File name
Adv_SPC_bNT_4_0_IE_clean.docx
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated in section 4.4, Special warnings and precautions for use, with additional information on aortitis in cancer patients and normal stem cell donors and in section 4.8, Undesirable effects, with aortitis as a rare adverse reaction. Reporting of adverse events in section 4.8 is also updated in line with REG30-REG31-WI-GBR01.
Updated on 29 May 2018
File name
Adv PIL bNT 4_0 UK & IE_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 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 03 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 03 November 2017
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.4 - Special precautions for storage
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 4.8, UK Adverse event reporting details have been updated in line with the current Appendix V to include Google Play and Apple App Store.
Section 6.4, revised to reflect extension of out of fridge stability from maximum 7 days to 15 days.Updated on 01 November 2017
File name
PIL_16940_856.pdf
Reasons for updating
- New PIL for new product
Updated on 01 November 2017
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 23 June 2017
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 November 2016
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 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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
Updates to sections 1, 2 4.2, 4.4, 4.6, 4.7, 4.8. 4.9, 5.1, 5.3, 6.4, 6.5, 8 and 10 to make changes in-line with the latest QRD template version 10.
Updated on 24 October 2016
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 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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
Updates to sections: 1 , 2 4.2, 4.4, 4.6, 4.7, 4.8. 4.9, 5.1, 5.3 6.4, 6.5, 8 and 10 in line with brand SPC & QRD updates.
Updated on 20 October 2016
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
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 05 October 2016
Reasons for updating
- New PIL for medicines.ie