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REVAXIS

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Pharmacy Only: Prescription

Updated on 12 July 2024

File name

087 IE-NL mockup PIL_new pack share.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • 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

Updated on 13 September 2023

File name

087_IE_SmPC_VarIB-addition for acronym_clean (2).pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 13 September 2023

File name

087_IE_SmPC_VarIB-addition for acronym_clean (2).pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 13 September 2023

File name

087_IE_SmPC_VarIB-addition for acronym_clean (2).pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 15 June 2023

File name

087_IE_SmPC_VarIB-addition for acronym_clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Updated on 15 June 2023

File name

087 - UK-IE - leaflet mockup - DEHxxxxWS1211.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for

Updated on 18 April 2023

File name

087 - Revaxis_UKIE_mockup PIL_EMEAHCXXXXWS2326G (2).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 - excipient warnings

Updated on 17 April 2023

File name

087_IE_SmPC_VarIIG_Update to qualitative and quantitative composition_WS2326G (1).pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Updated on 01 March 2023

File name

087 - UK-IE - leaflet mockup - SEHxxxxWS555.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 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

Updated on 01 March 2023

File name

087 - IE - spmc clean - SEHxxxxWS555.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 15 February 2021

File name

087_uk-ie_mockup leaflet_Change of barcode + update of Med Info number.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 27 July 2020

File name

087_uk-ie_pil_DEHxxxxWS477_Removal of abnormal toxicity test CCDSv6.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 27 July 2020

File name

087_ie_smpc clean_DEHxxxxWS477_Removal of abnormal toxicity test CCDSv6.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 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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

Sections 2, 4.4, 4.8, 6.1, 6.5 and 10 of the SPC have been updated.

Updated on 05 September 2019

File name

uk-ie-pil--revaxis-distributor address change-clean.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 05 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 05 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 04 January 2018

File name

PIL_10942_935.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 January 2018

Reasons for updating

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

Updated on 23 March 2017

Reasons for updating

  • Change in co-marketing arrangement

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 03 December 2014

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 03 December 2014

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 19 May 2014

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

Reasons for updating

  • Improved electronic presentation

Updated on 24 February 2009

Reasons for updating

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

Updated on 22 April 2008

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

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

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

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 26 May 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 August 2005

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 06 August 2004

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

Reasons for updating

  • New SPC for medicines.ie

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