ViATIM
- Name:
ViATIM
- Company:
Sanofi Pasteur
- Active Ingredients:
Hepatitis A Vaccine, Purified Inactivated, for Adults, Typhoid Vaccine
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/09/19
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Sanofi Pasteur
Company Products
| Medicine Name | Active 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 TETRAVAC | Active Ingredients Diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated) 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 |
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 8 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 8 January 2018 SPC
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 5 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 5 January 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 27 July 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 14 March 2017 PIL
Reasons for updating
- Change of distributor details
Updated on 17 January 2017 SPC
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
Updated on 16 January 2017 PIL
Reasons for updating
- Company name change or merger
Updated on 2 March 2015 SPC
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 2 March 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 2 November 2012 SPC
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 1 November 2012 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 1 November 2012 SPC
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 7 December 2011 SPC
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 5.1 there has been an insertion of serological data
Updated on 11 December 2009 SPC
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.
09/2009Updated on 9 December 2009 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 8 August 2008 PIL
Reasons for updating
- Change to packaging
- Change to date of revision
Updated on 21 July 2008 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 19 March 2007 PIL
Reasons for updating
- Change to marketing authorisation holder address
- Change to date of revision
Updated on 19 March 2007 SPC
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
Updated on 22 January 2007 PIL
Reasons for updating
- Improved electronic presentation
Updated on 22 January 2007 SPC
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 26 May 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 10 August 2005 SPC
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 SPC
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 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)