Menitorix powder and solvent for solution for injection
*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 18 February 2022
File name
ie-pl-menitorixissue7draft1-compendia.pdf
Reasons for updating
- Change to other sources of information section
Updated on 24 December 2019
File name
ie-pl-menitorixissue6draft2.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Information for healthcare professionals: Added information on the use and handling of Plastic Rigid Tip Cap (PRTC) syringes containing the solvent used for the reconstitution of the vaccine.
Section 5: Replaced the statement that the vaccine should be discarded if not used within 24 hours of reconstitution with a statement that the vaccine should not be administered.
Section 4: Updated the HPRA details for adverse event reporting.
Section 6: Deleted Poland from the list of countries where the vaccine is authorised.
Section 6: Changed the date of revision to 10/2019.
Updated on 24 December 2019
File name
ie-spc-menitorixissue7draft2.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Section 6.6: Added information on the use and handling of Plastic Rigid Tip Cap (PRTC) syringes containing the solvent used for the reconstitution of the vaccine.
Sectrion 6.3: Replaced the statement that the vaccine should be discarded if not used within 24 hours of reconstitution with a statement that the vaccine should not be administered.
Section 4.8: Updated the HPRA details for adverse event reporting.
Section 10: Changed the date of revision to 19 December 2019.
Updated on 27 September 2019
File name
ie-pl-menitorixissue5draft1-medsie.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Deletion of Poland under the following section: This medicinal product is authorised in the Member States of the EEA under the following names
Updated on 27 September 2019
File name
ie-spc-menitorixissue6draft1-medsie.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
section 6.3 - shelf life has changed from 3 years to 5 years
Updated on 17 April 2019
File name
ie-spc-menitorixissue5draft1-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 has been updated 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 Menitorix.’
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 Menitorix.’
Updated on 26 February 2019
File name
ie-pl-menitorixissue4draft1 - Meds ie.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 February 2019
File name
ie-spc-menitorixissue4draft1 - Meds ie.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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)
Updated on 17 August 2018
File name
ie-spcmenitorix.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 June 2018
File name
ie-spcmenitorix.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 May 2018
File name
ie-spcmenitorixsgds09issue3draft1-2.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 May 2018
File name
menitorix.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 May 2018
File name
menitorix.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 May 2018
File name
menitorix.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 March 2017
File name
PIL_16724_919.pdf
Reasons for updating
- New PIL for new product
Updated on 13 March 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Improved presentation of PIL
Updated on 06 May 2016
Reasons for updating
- New PIL for medicines.ie