MENJUGATE 10 micrograms suspension for injection (PFS)
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
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 04 October 2021
File name
ie-spc-pfs-menjugate liquid-issue5draft1- medie.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)
Updated on 10 January 2020
File name
ie-spc-pfs-menjugate liquid-issue4draft1medsie.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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
Renewal date added to section 9
Updated on 17 April 2019
File name
ie-spc-pfs-menjugate liquid-issue3draft1-medsie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 corrected from:
Individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis group C even following vaccination with Menjugate.’
to:
‘Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group C, even if they develop antibodies following vaccination with Menjugate.’
Updated on 26 February 2019
File name
ie-pil-vial-pfs-menjugate liquid-issue2draft1-MED.IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 26 February 2019
File name
ie-spc-pfs-menjugate liquid-issue2draft1-MED.IE.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
4.4 Special warnings and precautions for use - ” update to section relative to individuals receiving treatment that inhibits terminal complement activation (for example eculizumab)
Updated on 12 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 February 2018
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Change from joint to individual SPCs
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration - minor update for sentence to read better.
4.4 Special warnings and precautions for use - minor updates to read better.
4.8 Undesirable effects - addition of General disorders and administration site conditions
Very rare: Extensive swelling of the vaccinated limb
Plus change from joint to individual SPCs
Updated on 09 February 2018
File name
PIL_16454_666.pdf
Reasons for updating
- New PIL for new product
Updated on 09 February 2018
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
Updated on 21 December 2015
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
Updated on 18 December 2015
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 17 August 2015
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 13 August 2015
Reasons for updating
- New PIL for medicines.ie