NIPENT 10mg Powder for solution for injection or infusion
*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 18 November 2025
File name
Reg PIL gxNI 12_0 IE_Clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes.
Updated on 18 November 2025
File name
Reg SPC gxNI 6_2 IE_Clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- 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
The SPC has been updated as follows:
Sections 4.4 and 4.6 - addition of information providing advice on adequate duration of contraception for female patients & advice to lactating women on the adequate duration to abstain from breastfeeding. addition of information on contraception for male patients
-Section 5.3 – addition of information regarding incompletely reversible seminiferous tubular atrophy and degeneration in rats and in dogs
-Correction of minor typos throughout.
Updated on 02 September 2025
File name
Reg PIL gxNI 11_0 IE_Clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 October 2024
File name
Reg PIL gxNI 9_0 IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 October 2024
File name
Reg SPC gxNI 5_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 20 December 2023
File name
Reg PIL gx NI 8 0 IE CLEAN.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 February 2023
File name
DEC202101094_Reg SPC gxNI 4_1 IE_clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 February 2021
File name
DEC202108309_Reg PIL gxNI 7_0 IE_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 11 January 2021
File name
DEC202101094_Reg SPC gxNI 4_1 IE_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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:
Addition of excipient – sodium information to section 4.4.
Update to section 4.8 Irish reporting details in line with QRD guidelines.
Updated on 11 January 2021
File name
DEC202101094_Reg PIL gxNI 6_1 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 - marketing authorisation holder
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 11 October 2018
File name
Reg PIL gxNI 4_1 UK IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 11 October 2018
File name
Reg SPC gxNI 2_1 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 08 October 2018
File name
Reg PIL gxNI 4_1 UK IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 08 October 2018
File name
Reg SPC gxNI 2_1 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 08 August 2018
File name
Reg PIL gxNI 3_0 UK IE-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 31 July 2018
File name
Reg PIL gxNI 2_4 UK IE-clean.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 16 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 15 November 2017
File name
PIL_17354_219.pdf
Reasons for updating
- New PIL for new product
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363