INDICATION & USAGE

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus, approved for use in individuals 2 months of age and older.

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, any other Japanese encephalitis vaccine,  or any component of IXIARO, including protamine sulfate a compound known to cause hypersensitivity reactions in some individuals is a contraindication to administration of IXIARO.  Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals.  Individuals with a weakened immune system may have a diminished immune response to IXIARO.  Fainting may occur when receiving any injection, including IXIARO.  Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.  You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

    

INDICATION & USAGE

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus, approved for use in individuals 2 months of age and older.

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, any other Japanese encephalitis vaccine,  or any component of IXIARO, including protamine sulfate  a compound known to cause hypersensitivity reactions in some individuals  is a contraindication to administration of IXIARO.  Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals.  Individuals with a weakened immune system may have a diminished immune response to IXIARO.  Fainting may occur when receiving any injection, including IXIARO.  Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.  You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

    

 

 

 

Privacy Declaration

 

Last Updated: 01. May 2019

Valneva SE and its affiliates (“Valneva“,“we“, “us” or “our“) have created this privacy declaration (hereafter referred to as the “Privacy Declaration“) in order to demonstrate our firm commitment to privacy. The following discloses our processing of personal data (Article 4/1 Regulation (EU) 2016/679, “GDPR”) with regard to the use of our websites as well as with regard to our customers, pharmacovigilance, vendors and persons applying for a job at Valneva.

This Privacy Policy applies to individuals we deal with including consumers, patients, health care professionals and others within the health care or pharmaceutical industries (“you” or “your“), and explains how we collect, use, disclose and otherwise process and protect your Personal Data. This Privacy Policy further includes a description of your data privacy rights as a data subject.

1.    Use of the Websites

With using our websites www.valneva.com, www.valneva.at, www.valneva.se, www.valnevauk.com, www.valneva.us, www.valneva.ca, www.preventje.com and the sub-sites under the listed domains you accept that we collect and process data regarding your behaviour on our website.

This processing is based on your consent being given by the usage of this website.

The Site may collect information from visitors both by asking you specific questions and by permitting you to communicate directly with us via email and/or feedback forms. Some of the information that you submit on the Site may be Personal Data. A site may further use “cookies” and Internet Protocol (“IP”) addresses. A cookie is a bit of information that a website sends to your web browser that helps the site remember information about you and your preferences and an IP address is a number assigned to your computer by your Internet service provider. The IP address can be used to diagnose problems with a server, report aggregate information, determine the fastest route for your computer to use in connecting to a site, and administer and improve the site. Please read more here: https://www.valneva.com/en/legal/cookie-policy

Please note that if you wish to subscribe and connect your personal social media account to our Site, e.g. if you would like to share information on your own social media account, certain Personal Data will be shared with us such as Personal Data linked to your profile or your friends profiles on the applicable social media account.

2.    Pharmacovigilance

Pharmacovigilance is the process of discovering, evaluating, understanding and preventing adverse reactions or other problems related to medicines. Their notification is of great importance for public health. We will only use and share this information for pharmacovigilance purposes. This processing is necessary for compliance with a legal obligation to which Valneva is subject.

Valneva is required to store and report information relevant to pharmacovigilance to health authorities worldwide (including countries whose data protection levels differ from those of the EU). The reports contain detailed information on the incident, but only to a limited extent personal data.

With regard to patients, the notification will contain, if available, only age, date of birth, year of birth, gender and initials, depending on the information available, but never the name of the patient.

With regard to the notifier, the notification will include, depending on the information available, the name, professional activity (e.g. doctor, pharmacist), address, e-mail address and telephone number. The contact details are necessary to be able to follow up the reporting and thus obtain high-quality and complete information on adverse events.

Information on notifications will be kept for at least ten (10) years after the product is no longer on the market in any country. 

3.    Recruitment:

We will store and process your data for the purpose of your application based on your consent and based on Article 6/1 lit b General Data Protection Regulation. We will forward your personal data and the attachments you provided to the respective country organization with applicable open job opportunities. We will keep your personal data in evidence for filling additional positions for a maximum period of seven months from the date of the receipt of your application.

Your data will be kept strictly confidential, will not be passed on to any other companies except Valneva country organizations with applicable open job opportunities and will only be passed on within the company to the heads of departments where a suitable position is available.

Your data will be deleted automatically after seven (7) months from the date of receipt of your application. You can revoke your consent to data processing at any time in writing via gdpr@valneva.com. In this case please refer to your job application and we will delete your personal data.

4.    Vendor, customer or other business partners:

We will not use your personal data for marketing activities unless you have consented to receive marketing communications from us. 

Based either on consent or, when applicable, on the fulfilment of contractual obligations, we will store your name, contact details and your position within your company being a vendor, customer or other business partner.

Based on your consent, we will publish your data as a health care professional on our website www.reisemedizincheck.at (for Austria) or www.bewareofthebugs.com (for United Kingdom).

5.    Medical Requests:

Your medical requests regarding our products will be stored due to legal obligations and in the legitimate interests of Valneva to have evidence about the information provided when replying to medical requests. We will store your name, contact details, content of your request and content of our reply to your request.

We will store this data for a period of 30 years after having received your medical request.

6.    Security

We take reasonable steps to protect your Personal Data using physical (locked filing cabinets and restricted access to offices), electronic (especially firewalls) or procedural security measures appropriate to the sensitivity of the information. Valneva will take appropriate steps to ensure that Personal Data about you is protected from loss or theft, as well as unauthorised access, disclosure, copying, use or modification.

Although we have enacted security measures, we cannot guarantee the security of any information that you submit via email or over the Internet. To the extent permitted under applicable law, we make no warranty, express or implied, concerning the security or integrity of any Personal Data. You submit your Personal Data using such networks at your own risk, since no Internet transmission is ever 100% secure or error-free (in particular, emails sent to or from the Site may not be secure). You should take special care in deciding what information you send to us via email or posting on the Site. Moreover, where you use passwords, ID numbers or other special access features on the Site, it is your responsibility to safeguard them.

7.    Links to other Websites

The Site may contain links or references to other websites to which this Privacy Policy does not apply. Valneva is not responsible for the data collection and use practices of companies or organisations to which the Site may provide links. We encourage you to read the privacy statement/policy of every website you visit.

Valneva makes no representations whatsoever about any other website which you may access through this Site. In addition, a link to a website does not mean that Valneva endorses or accepts any responsibility for the content, or the use, of such website

8.    Collection of Personal Data from Children

This Site is not directed to individuals under the age of sixteen (16) (or such other lower age determined by applicable laws), and we do not knowingly collect any Personal Data from children under such age. 

Should we need to process Personal Data of an individual under the age of sixteen (16) (or such other lower age determined by applicable laws) consent to such processing must be given by an authorized person with parental responsibility for the child.

9.    Privacy Policy Changes

This Privacy Policy may be revised from time to time. If we intend to use or disclose Personal Data for purposes materially different than those described in this Privacy Policy, we will make reasonable efforts to notify affected individuals, if necessary, including by posting the revised Privacy Policy on this Site. We recommend that you review this Privacy Policy frequently.

10.    Information Regarding Your Rights

If you would like to access your Personal Data or get it rectified, updated, erased or transferred to other organizations please contact us at the address below. You also have the right to object or to restrict some processing and, where we have asked for your consent to process your Personal Data, to withdraw your consent at any time and we will stop any future use of your Personal Data (unless there is a legitimate interest that prevents us from doing so). We may request a reasonable fee for administering certain requests. Authorised employees, agents and representatives of Valneva who require access to your Personal Data in order to fulfil their job requirements will have access to your Personal Data.

You may contact us by writing to us at the following address:

Valneva Austria GmbH, Campus Vienna Biocenter 3, A-1030 Vienna, Austria

You may also contact Valneva`s Data Protection Officer at:

gdpr@valneva.com

NOTE: If you are a physician or other health care professional and would like to record an adverse event, please contact safety@valneva.com

11.    Contact the Supervisory Authority

If you have any comments or complaints regarding the way your Personal Data is being handled, you have the right to contact the supervisory authority in your country of residence to lodge a complaint. Please click here to obtain relevant contact information to supervisory authorities:  http://ec.europa.eu/justice/article-29/structure/data-protection-authorities/index_en.htm

 

 

 

Indication & Usage

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus, approved for use in individuals 2 months of age and older.

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, other Japanese encephalitis vaccine, any or any component of IXIARO, including protamine sulfate ─ a compound known to cause hypersensitivity reactions in some individuals ─ is a contraindication to administration of IXIARO. Individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals. Individuals with a weakened immune system may have a diminished immune response to IXIARO. Fainting may occur when receiving any injection, including IXIARO. Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967. You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

 

 

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