The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

Sanofi Pasteur MSD Limited
Mallards Reach, Bridge Avenue, Maidenhead, Berkshire, SL6 1QP
Telephone: +44 (0)1628 785 291
Fax: +44 (0)1628 671 722
Medical Information Direct Line: +44 (0)1628 587 693
Medical Information e-mail: medinfo@spmsd.com
Medical Information Fax: +44 (0)1628 635 072
Need to contact this company?
Summary of Product Characteristics last updated on the eMC: 21/11/2008
SPC AVAXIM

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 21/11/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • 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-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 2 - qualitative and quantitative composition

Changed mL to millilitre in line with current guidelines.  Added ‘Excipient(s)’ as per QRD template.

Change to section 4.1 - therapeutic indications

Wording at end of 1st paragraph changed to improve clarity.

Change to section 4.2 - Posology and method of administration

Added heading ‘Posology’ to aid navigation, information moved into more appropriate sections, cross-reference to other sections to meet QRD template.

Change to section 4.3 - Contra-indications

Re-worded contraindication on hypersensitivity as per QRD template.

Change to section 4.4 - Special warnings & precautions for use

Information moved into more appropriate sections and re-ordered as per SPC guideline.

Change to section 4.5 - Interactions with other medicaments

Re-worded to improve clarity.

Change to section 4.6 - Pregnancy and lactation

Headings added to aid navigation and text on pregnancy re-worded in line with QRD template.

Change to section 4.7 - Effects on ability to drive and use machines

Re-worded in line with QRD template.

Change to section 4.8 - Undesirable effects

Section re-organised in line with QRD template.

Change to section 4.9 - Overdose

Amended to state whether any cases of overdose have been reported.

Change to section 5.1 - Pharmacodynamic properties

Pharmacotherapeutic group has been added, as per SPC guidelines.

Change to section 5.2 - Pharmacokinetic properties

Re-worded to improve clarity.

Change to section 5.3 - Preclinical safety data

Re-worded as per QRD template.

Change to section 6.1 - List of excipients

Re-formatted to improve clarity.  Mention of phenylalanine, as per guideline on excipients.

Change to section 6.4 – Special precautions for storage

Re-worded according to QRD template.

Change to section 6.6. – Instructions for use/handling

Added sentences as per the guideline ‘Pharmaceutical aspects of the product information for human vaccines’ and as per QRD template.

Change to section 10 – Date of partial revision of the text.

October 2008
Updated on 20/09/2006 and displayed until 21/11/2008
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of the word “section” before “6.1”.

6.1 List of Excipients - The wording “the formulation contains:” has been deleted

6.2 Incompatibilities - Rewording of sentence to bring it in line with the Guideline on Pharmaceutical aspects of the product information for human vaccines.
Updated on 20/09/2005 and displayed until 20/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/09/2004 and displayed until 20/09/2005
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/01/2003 and displayed until 29/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 27/09/2002 and displayed until 13/01/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 23/08/2001 and displayed until 27/09/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  hepatitis a vaccine (inactivated, adsorbed)


Return to the top of the page

© 2009 Datapharm Communications Ltd

Go to www.medicines.org.uk