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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 09/03/2011
SPC Menitorix

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 09/03/2011 and displayed until Current
Reasons for adding or 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
2. Statement on sodium chloride
4.2 Method of administration heading
4.4 Information on sodium content
4.6 Change in heading (Fertility)
4.8 Minor administrative changes to format
6.4 Administrative changes re storage
10 Date  (Approved 3 March 2011 and includes changes from 26 January 2011, but section 10 backdatged to 19 December 2010 in line with the expiry date of previous licence)
Updated on 03/02/2011 and displayed until 09/03/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2 Deletion of long term immonogenicity statement
4.8 Typographical changes and re-arrangement of the order of Immune sysem disorder
5.1 Update of the long-term persistence data (studies Hib-MenC-TT-028 EXT:013 M24 and Hib-MenC-TT-024 EXT:010 M42
10 26 January 2011
Updated on 03/06/2009 and displayed until 03/02/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 - Updated to include information on risk of apnoea in very premature infants

 

Section 4.8 - Addition of apnoea as adverse event seen in post-marketing experience

 

Section 5.1 - Updated information describing post-marketing surveillance following UK immunisation campaign

 

Section 10 - Date of MHRA approval
Updated on 06/11/2008 and displayed until 03/06/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - Black triangle removed

Section 10 - Updated to date of MHRA advisory
Updated on 02/05/2008 and displayed until 06/11/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 1 - change in generic name
Section 2 - formatting
Section 3 - change in description
Section 4.1 - formatting
Section 4.2 - section re-arranged
Section 4.4 - minor changes - includes definition of Hib diagnostic tests needed post vaccination
Section 4.5 - minor changes including comment on concomitant use of other vaccines
Section 4.8 - change in formatting and addition of undesirable effects from post marketing
Section 5.1 - change in ATC code: clinical data expanded on a larger cohort of vaccinees
Section 5.2 - clarification statement
Section 6.1 - Trometamol for Tris: Water for Injections added
Section 6.3 - addition of in use stability data and storage information
Section 6.5 - needles in packs clarified
Section 6.6 - description of vaccine update
Section 10 - date updated
Updated on 22/12/2005 and displayed until 02/05/2008
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  hib meningococcal group c combined vaccine