NIPENT 10mg Powder for solution for injection or 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 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