REVAXIS

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/09/19

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Summary of Product Characteristics last updated on medicines.ie: 5/1/2018
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Sanofi Pasteur

Sanofi Pasteur

Company Products

Medicine NameActive Ingredients
Medicine Name AVAXIM Active Ingredients Inactivated Hepatitis A Vaccine
Medicine Name Quadrivalent Influenza vaccine (split virion, inactivated) Active Ingredients Influenza vaccine (split virion, inactivated)
Medicine Name Rabies Vaccine BP Active Ingredients Rabies Vaccine BP
Medicine Name REVAXIS Active Ingredients Diphtheria Vaccine, Poliomyelitis Vaccine, Tetanus Vaccine
Medicine Name STAMARIL Active Ingredients Yellow Fever Vaccine
Medicine Name TYPHIM Vi Active Ingredients Vi Capsular Polysaccharide vaccine
Medicine Name ViATIM Active Ingredients Hepatitis A Vaccine, Purified Inactivated, for Adults, Typhoid Vaccine
1 - 0 of 7 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 5 September 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 6: Distributor address change

Section 6: Date of revision

Updated on 5 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 January 2018 SmPC

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

Change of MAH address from 2, avenue Pont Pasteur 69007 Lyon, France to 14 Espace Henry Vallée 69007 Lyon, France

Updated on 4 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 23 March 2017 PIL

Reasons for updating

  • Change in co-marketing arrangement

Updated on 17 January 2017 SmPC

Reasons for updating

  • Company name change or merger

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sanofi Pasteur MSD company name changed to Sanofi Pasteur

Updated on 16 January 2017 PIL

Reasons for updating

  • Company name change or merger

Updated on 3 December 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 3 December 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 2 (qualitative and quantitative composition) -  "For a full list of excipients, see section 6.1" to read "For the full list of excipients, see section 6.1"

In sections 4.3, 4.6 and 4.8 - implement the SmPC guideline requirements (September 2009), the QRD template V2 and the Adverse Events reporting (QRD template version 3, April 2013)

In section 10 - revision date changed to 31st October 2014


Updated on 19 May 2014 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 6.5 change to composition of immediate packaging

Updated on 31 March 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 24 February 2009 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 22 April 2008 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to side-effects
  • Change to warnings or special precautions for use

Updated on 17 April 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1        
 
Minor amendment to international non proprietary name

Section 4.4     
 
Addition of warning regarding administration via IV or ID route.
Addition of warning regarding GBS and BN following previous vaccination with a tetanus containing vaccine.
 

Section 4.8 - Addition of side effects

 

Updated on 24 April 2007 SmPC

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

Section 7 - updated the address of the Marketing Authorisation Holder.

Section 10 - changed date of revision to March 2007

Updated on 24 April 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 26 May 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 August 2005 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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)

Updated on 6 August 2004 SmPC

Reasons for updating

  • 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 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)