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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 18 February 2021

File name

150_uk+ie_pil_SEHxxxxWS421 VarII Ethanol + excipient update_1613655618.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 February 2021

File name

150_ie_smpc_SEHxxxxWS421_VarII Ethanol + excipient update_1613655355.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 6.1 - List of excipients

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

Updated on 05 September 2019

File name

uk-ie-viatim-pil-distributor address change-clean_1567672430.pdf

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 08 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 08 January 2018

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 05 January 2018

File name

PIL_10941_8.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 January 2018

Reasons for updating

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

Updated on 27 July 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 14 March 2017

Reasons for updating

  • Change of distributor details

Updated on 17 January 2017

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

Reasons for updating

  • Company name change or merger

Updated on 02 March 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 02 March 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.4 addition of syncope (fainting)

Section 4.8 addition of vasovagal syncope in response to injection and inclusion of reporting of suspected adverse reactions

Section 10 revision date revised to January 2015

Updated on 02 November 2012

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC

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

Free text change information supplied by the pharmaceutical company



Section 1: Name change from Suspension and solution for injection in a prefilled dual chamber syringe to Suspension and solution for suspension for injection in pre-filled syringe.

 

Section 2: Deletion of purified Vi polysaccharide and replaced with inactivated hepatitis A vaccine and 0.5 millilitre of typhoid polysaccharide.

Section 4.2: Inclusion of Paediatric population The safety and efficacy of ViATIM in children and adolescents below 16 years have not yet been established. No data are available.

Section 4.5: specific concomitant administration stated

Section 4.6: Headings included plus; Fertility No fertility data are available.

 

Section 4.7: Included ViATIM has a minor influence on the ability to drive and use machines.

 

Section 4.8: Frequencies re-arranged

 

Section 4.9: Included the following statement; Cases of overdose have been reported with ViATIM where it was administered concomitantly with typhoid polysaccharide and/or hepatitis A vaccines. When adverse reactions were reported, they did not differ in nature from those described in section 4.8.

 

Section 5.1: ATC code updated to J07CA10 typhoid-hepatitis A. Inclusion of tables containing the Seroconversion/seroprotection rates observed 28 days after vaccination.

 

Section 6.1: re-arranged section to be consistent with the rest of the changes in section 2

 

Section 6.4: deleted if frozen the vaccine should be discarded

 

Section 6.5: re-arranged section to be consistent with the rest of the changes in section 2

 

Section 6.6: Harmonised

 

Section 9: Date of authorisation corrected

 

Section 10: date of revision changed to October 2012

 

 

 

 

Updated on 01 November 2012

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 01 November 2012

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 6.1 - List of excipients
  • 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 10 - Date of revision of the text
  • Change due to harmonisation of SPC

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

Free text change information supplied by the pharmaceutical company

Section 1: Name change from Suspension and solution for injection in a prefilled dual chamber syringe to Suspension and solution for suspension for injection in pre-filled syringe.

 

Section 2: Deletion of purified Vi polysaccharide and replaced with inactivated hepatitis A vaccine and 0.5 millilitre of typhoid polysaccharide.

Section 4.2: Inclusion of Paediatric population The safety and efficacy of ViATIM in children and adolescents below 16 years have not yet been established. No data are available.

Section 4.5: specific concomitant administration stated

Section 4.6: Headings included plus; Fertility No fertility data are available.

 

Section 4.7: Included ViATIM has a minor influence on the ability to drive and use machines.

 

Section 4.8: Frequencies re-arranged

 

Section 4.9: Included the following statement; Cases of overdose have been reported with ViATIM where it was administered concomitantly with typhoid polysaccharide and/or hepatitis A vaccines. When adverse reactions were reported, they did not differ in nature from those described in section 4.8.

 

Section 5.1: ATC code updated to J07CA10 typhoid-hepatitis A. Inclusion of tables containing the Seroconversion/seroprotection rates observed 28 days after vaccination.

 

Section 6.1: re-arranged section to be consistent with the rest of the changes in section 2

 

Section 6.5: re-arranged section to be consistent with the rest of the changes in section 2

 

Section 6.6: Harmonised

 

Section 10: date of revision changed to 08/2012

Updated on 07 December 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.2 there has been an inclusion of long term immunity
In section 5.1 there has been an insertion of serological data

Updated on 11 December 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 to section 4.8 - Undesirable effects

Update to mention both anaphylactic and anaphylactoid reactions (including shock) as immune system disorders

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

09/2009

Updated on 09 December 2009

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 08 August 2008

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 21 July 2008

Reasons for updating

  • Change due to user-testing of patient information

Updated on 19 March 2007

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 January 2007.

Updated on 19 March 2007

Reasons for updating

  • Change to marketing authorisation holder address
  • Change to date of revision

Updated on 22 January 2007

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of 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

Sections 1-10:  Removal of ® symbol in line with QRD template.

 

Sections 4.3, 4.6, 4.7, 4.8, 5.3, 6.4, and 6.5: Updated in line with QRD template


Section 9: Changed to 3rd September 2001/3rd September 2006

 

Section 10: Changed to December 2006

Updated on 22 January 2007

Reasons for updating

  • Improved electronic presentation

Updated on 26 May 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 August 2005

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)

Updated on 19 November 2004

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 26 August 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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