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
- Name:
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 Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/12/19
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Pfizer Healthcare Ireland
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 17 December 2019 SmPC
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
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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 PIL
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 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 17 April 2019 SmPC
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
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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 4 January 2019 PIL
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 SmPC
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
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The SPC has been updated as follows: |
Updated on 11 September 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 September 2018 SmPC
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 SmPC
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 PIL
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 SmPC
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 PIL
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 3 November 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 November 2017 SmPC
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 1 November 2017 PIL
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 1 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 23 June 2017 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 November 2016 SmPC
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 SmPC
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 PIL
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 6 October 2016 SmPC
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 5 October 2016 PIL
Reasons for updating
- New PIL for medicines.ie