Keppra 100mg/ml concentrate for solution for infusion
*Company:
UCB (Pharma) Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 01 March 2023
File name
Keppra Solution for Infusion.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 March 2023
File name
Keppra Injection PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 10 September 2021
File name
PIL IV.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Var II - CCDS.v.5.0 - Neuroleptic Malignant Syndrome
Updated on 10 September 2021
File name
SPC IV.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Var II - CCDS.v.5.0 - Neuroleptic Malignant Syndrome
Updated on 27 July 2021
File name
IE SPC IV.pdf
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
IA - Change of container closure (Removal of grey rubber stopper)
Updated on 13 January 2021
File name
PIL IV.pdf
Reasons for updating
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Update to recommend the same dosing for monotherapy and adjunctive therapy – SmPC Section 4.2 - PIL section 3
Updated on 13 January 2021
File name
SPC IV.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to recommend the same dosing for monotherapy and adjunctive therapy – SmPC Section 4.2
Updated on 20 October 2020
File name
PIL IV.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Correction to the stated Manufacturer in section 6
Updated on 20 October 2020
File name
PIL IV.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 6 - date of revision
Free text change information supplied by the pharmaceutical company
Addition of warning and adverse reaction of QT Prolongation – Section 2 & 4
Updated on 20 October 2020
File name
SPC IV.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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of warning and adverse reaction of QT Prolongation – Section 2 & 4
Updated on 31 July 2020
File name
pil IV ie .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 6 - date of revision
Free text change information supplied by the pharmaceutical company
Addition of the warning and ADR on “Worsening Seizures”
Updated on 31 July 2020
File name
spc IV ie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of the warning and ADR on “Worsening Seizures”
Updated on 18 October 2019
File name
ie spc iv 100 mgml.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 October 2019
File name
keppra pil i.v. injection.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 01 April 2019
File name
20190328-ie-pil-conc-en-approved-current.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 March 2019
File name
20190328-ie-spc-conc-en-approved-current.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 March 2019
File name
20180426-ema-ie-pil-conc-h277-en-approved-current.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 13 March 2019
File name
20180426-ema-ie-spc-conc-h277-en-approved-current.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Pregnancy wording update, dysgeusia, pregnancy malformation update and gait disturbance
Updated on 02 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 December 2016
File name
PIL_11237_598.pdf
Reasons for updating
- New PIL for new product
Updated on 23 December 2016
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 07 September 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 24 March 2014
Reasons for updating
- Change to side-effects
Updated on 09 January 2014
Reasons for updating
- Change to side-effects
Updated on 10 August 2012
Reasons for updating
- Change to side-effects
Updated on 16 December 2011
Reasons for updating
- Correction of spelling/typing errors
Updated on 28 November 2011
Reasons for updating
- Change to side-effects
Updated on 19 October 2011
Reasons for updating
- Change of manufacturer
- Change to side-effects
Updated on 13 May 2011
Reasons for updating
- Change to MA holder contact details
Updated on 06 December 2010
Reasons for updating
- Change to improve clarity and readability
Updated on 06 April 2010
Reasons for updating
- Change to dosage and administration
Updated on 10 March 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 18 February 2008
Reasons for updating
- Change of manufacturer
Updated on 09 August 2007
Reasons for updating
- Change of manufacturer
Updated on 05 February 2007
Reasons for updating
- Change to, or new use for medicine
Updated on 14 August 2006
Reasons for updating
- New PIL for new product