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GILENYA World Watch

Many patients with relapsing-remitting multiple sclerosis* around the globe have already been treated with GILENYA® (fingolimod).

Click on the tallies below to learn more about the clinical trials and the global distribution of GILENYA prescriptions to date.

Privacy policy

This Privacy Statement describes the ways in which we, Novartis AG, collect, hold and use information about individual persons who visit this website. BY USING THIS WEBSITE, YOU CONSENT TO THE COLLECTION AND USE OF INFORMATION AS SET FORTH IN THIS PRIVACY POLICY. YOU ALSO ACKNOWLEDGE THAT NOVARTIS AG MAY PERIODICALLY CHANGE, MODIFY, ADD OR REMOVE OR OTHERWISE UPDATE THIS PRIVACY POLICY AT ITS DISCRETION, WITHOUT PRIOR NOTIFICATION. However, we will always handle your Personal Information in accordance with the Privacy Policy that was in effect at the time of collection. It is our intention to post changes to our privacy policy on this page so that you are fully informed concerning the types of information we are gathering, how we use it, and under what circumstances it may be disclosed. Our Privacy Policy is located on our homepage and is also available on any page where Personal Data are requested. At such data collection points, further explanation may be provided, where appropriate, as to the purposes for which the data will be used.

1. Pledge on privacy

The term "Personal Data" as used in this Privacy Policy refers to information such as your name, birth date, e-mail address, mailing address, or telephone number that can be used to identify you. Generally, we will only process your Personal Data as described in this Privacy Policy. However, we reserve the right, to conduct additional processing to the extent permitted or required by law, or in support of any legal or criminal investigation.
The next sections explain how and when we collect Personal Data from you.

2. Intended use of Personal Data

Most of our services do not require any form of registration, allowing you to visit our site without telling us who you are. However, some services may require you to provide us with Personal Data. In these situations, if you choose to withhold any Personal Data requested by us, it may not be possible for you to gain access to certain parts of the site and for us to respond to your query.

We may collect and use Personal Data to provide you with products or services, to bill you for products and services you request, to market products and services which we think may be of interest to you, or to communicate with you for other purposes which are evident from the circumstances or about which we inform you when we collect Personal Data from you.

3. Non-disclosure of Personal Data

We will not sell, share, or otherwise distribute your Personal Data to third parties except as provided in this Privacy Policy. We may disclose your Personal Data to other Novartis affiliates worldwide that agree to treat it in accordance with this Privacy Policy. Personal Data may also be transferred to third parties who act for or on our behalf, for further processing in accordance with the purpose(s) for which the data were originally collected or may otherwise be lawfully processed, such as services delivery, evaluating the usefulness of this website, marketing, data management or technical support. These third parties have contracted with us to only use Personal Data for the agreed upon purpose, and not to sell your Personal Information to third parties, and not to disclose it to third parties except as may be required by law, as permitted by us or as stated in this Privacy Policy.

Personal Data collected from you may also be transferred to a third party in the event that the business of this site or a part of it and the customer data connected with it is sold, assigned or transferred, in which case we would require the buyer, assignee or transferee to treat Personal Data in accordance with this Privacy Policy. Also, Personal Data may be disclosed to a third party if we are required to do so because of an applicable law, court order or governmental regulation, or if such disclosure is otherwise necessary in support of any criminal or other legal investigation or proceeding here or abroad.

4. Right of access, correction and objection

Whenever we process Personal Data, we take reasonable steps to ensure that your Personal Data is kept accurate and up-to date for the purposes for which it was collected. We will provide you with the ability to object to the processing of your Personal Data if such processing is not reasonably required for a legitimate business purpose as described in this policy or our compliance with law. In the case of electronic direct marketing, we will provide you with a method to opt out of receiving further marketing materials or with a method to opt in if required by law. If you wish to contact us regarding our use of your Personal Data or object to the processing of your Personal Data, please email us at corporate.enquiries@group.novartis.com. If you contact us, please note the name of the website where you provided the information, as well as the specific information you would like us to correct, update or delete plus a proper identification of you. Requests to delete personal data will be subject to any applicable legal and ethical reporting or document filing or retention obligations imposed on us.

5. Security and confidentiality

To ensure the security and confidentiality of Personal Data that we collect online, we use data networks protected, inter alia, by industry standard firewall and password protection. In the course of handling your Personal Data, we take measures reasonably designed to protect that information from loss, misuse, unauthorized access, disclosure, alteration or destruction.

6. Data transfer abroad

We are part of the Novartis Group which is a global group of companies and has databases in different countries, some of which are operated by the local Novartis Group Company, and some of which are operated by third parties on behalf of the local Novartis Group Company. We may transfer your data to one of the Group's databases outside your country of domicile, potentially including countries which may not require an adequate level of protection for your Personal Data compared with that provided in your country.

7. "Cookies" and internet tags

We may collect and process information about your visit to this website, such as the pages you visit, the website you came from and some of the searches you perform. Such information is used by us to help improve the contents of the site and to compile aggregate statistics about individuals using our site for internal, market research purposes. In doing this, we may install "cookies" that collect the domain name of the user, your internet service provider, your operating system, and the date and time of access. A "cookie" is a small piece of information which is sent to your browser and stored on your computer’s hard drive. Cookies do not damage your computer. You can set your browser to notify you when you receive a "cookie," this will enable you to decide if you want to accept it or not. If you do not want us to install cookies, please email us at corporate.enquiries@group.novartis.com. We would like to inform you, however, that if you do not accept you may not be able to use all functionality of your browser software. We may obtain the services of outside parties to assist us in collecting and processing the information described in this Section.

Occasionally, we may use internet tags (also known as action tags, single-pixel GIFs, clear GIFs, invisible GIFs and 1-by-1 GIFs) and cookies at this site and may deploy these tags/cookies through a third-party advertising partner or a web analytical service partner which may be located and store the respective information (including your IP-address) in a foreign country. These tags/cookies are placed on both online advertisements that bring users to this site and on different pages of this site. We use this technology to measure the visitors' responses to our sites and the effectiveness of our advertising campaigns (including how many times a page is opened and which information is consulted) as well as to evaluate your use of this website. The third-party partner or the web analytical service partner may be able to collect data about visitors to our and other sites because of these internet tags/cookies, may compose reports regarding the website’s activity for us and may provide further services which are related to the use of the website and the internet. They may provide such information to other parties if there is a legal requirement that they do so, or if they hire the other parties to process information on their behalf. If you would like more information about web tags and cookies associated with on-line advertising or to opt-out of third-party collection of this information, please visit the Network Advertising Initiative website http://www.networkadvertising.org.

8. Personal information and children

Most of the services available on this site are intended for persons 18 years of age and older. Any individual who requests information about a medicine indicated for use in children must be 18 or over. We will not knowingly collect, use or disclose Personal Data from a minor under the age of 18, without obtaining prior consent from a person with parental responsibility (e.g., a parent or guardian) through direct off-line contact. We will provide the parent with (i) notice of the specific types of personal data being collected from the minor, and (ii) the opportunity to object to any further collection, use, or storage of such information. We abide by laws designed to protect children.

9. Links to other sites

This Privacy Policy applies only to this website, and not to websites owned by third parties. We may provide links to other websites which we believe may be of interest to our visitors. We aim to ensure that such websites are of the highest standard. However, due to the nature of the internet, we cannot guarantee the privacy standards of websites to which we link or be responsible for the contents of sites other than this one, and this Privacy Policy is not intended to be applicable to any linked, non-Novartis site.

10. Contact us

If you have any queries or complaints about our compliance with this Privacy Policy, or if you would like to make any recommendations or comments to improve the quality of our Privacy Policy, please email us at corporate.enquiries@group.novartis.com.

Terms

1. Acceptance

Your access to and use of this Site is subject to the following terms and conditions and all applicable laws. By accessing and browsing this Site, you accept, without limitation or qualification, these Terms and Conditions and acknowledge that any other agreements regarding the use of this Site between you and Novartis AG are superseded and of no force or effect.

2. Medical information/conditions

Product information on this web site is provided by Novartis AG and is intended for general information purposes only. Many pharmaceutical and medical device products listed are available upon prescription from a medical doctor or qualified medical professional only, and not all such products may be available in all countries. The product information is not intended to provide complete medical information. SHOULD YOU HAVE A MEDICAL CONDITION, PROMPTLY SEE YOUR OWN MEDICAL DOCTOR OR HEALTH CARE PROVIDER. WE DO NOT OFFER PERSONALIZED MEDICAL DIAGNOSIS OR PATIENT-SPECIFIC TREATMENT ADVICE. You should always obtain complete medical information about your prescription medicines or medical devices (including their beneficial medical uses and possible adverse effects) by discussing the appropriate use of any medicine(s) or medical devices directly with your prescribing physician or, where appropriate, other medical advisor. Medical professionals may obtain complete medical information from the product's information leaflet. Information on these products may vary by country. Patients, physicians and other medical professionals should check with local medical resources and regulatory authorities for information appropriate to their country. In addition, current regulations in many countries limit (or even prohibit in some instances) the ability of Novartis AG to provide information and/or to respond directly to patient questions regarding its prescription products. Novartis AG, however, will respond to inquiries from and provide information to your qualified health care professional in accordance with local regulations.

3. Use of information

You may freely browse the Site, but you may only access, download or use information from this Site, including any text, images, audio, and video (the "Information") for your own non-commercial use. You may not distribute, modify, transmit, reuse, repost, or use the Information for commercial purposes, without written permission of Novartis AG. You must retain and reproduce each and every copyright notice or other proprietary rights notice contained in any Information you download. You should assume that everything you see or read on this Site is copyrighted unless otherwise noted and may not be used except as provided in these Terms and Conditions or in the text on the Site without the written permission of Novartis AG. Except as otherwise permitted in this paragraph, Novartis AG neither warrants nor represents that your use of materials displayed on the Site will not infringe rights of third parties not owned by or affiliated with Novartis AG. With the exception of the foregoing limited authorization, no license to or right in the Information, or any copyright of Novartis AG or of any other party is granted or conferred to you.

4. Trademarks/proprietary rights

You should assume that all product names appearing on this Site, whether or not appearing in large print, italics or with the trademark symbol are trademarks of Novartis. This Site may also contain or reference patents, proprietary information, technologies, products, processes or other proprietary rights of Novartis AG and/or other parties. No license to or right in any such trademarks, patents, trade secrets, technologies, products, processes and other proprietary rights of Novartis AG and/or other parties is granted to or conferred upon you. All product names published in italics on this Site are trademarks owned by or licensed to the Novartis Group.

5. Disclaimer of warranties

While Novartis AG uses reasonable efforts to ensure that the Information is accurate and up to date, the Information may contain inaccuracies or typographical errors. Novartis AG reserves the right to make changes, corrections and/or improvements to the Information, and to the products and programs described in such Information, at any time without notice. Novartis AG makes no warranties or representations as to the accuracy of any of the Information. Novartis AG assumes no liability or responsibility for any errors or omissions in the content of the Site. ALL INFORMATION IS PROVIDED "AS IS." NOVARTIS PROVIDES NO WARRANTIES ABOUT THE COMPLETENESS OR ACCURACY OF THE INFORMATION ON THIS SITE OR ITS POSSIBLE USES. CONSEQUENTLY, THE INFORMATION SHOULD BE CAREFULLY EVALUATED BY SITE VISITORS. NEITHER NOVARTIS AG, NOR ANY OTHER NOVARTIS GROUP COMPANY, NOR ANY OTHER PARTY INVOLVED IN CREATING, PRODUCING OR DELIVERING THIS SITE TO YOU SHALL BE LIABLE FOR ANY DIRECT, INCIDENTAL, CONSEQUENTIAL, INDIRECT OR PUNITIVE DAMAGES ARISING OUT OF ACCESS TO, USE OF OR INABILITY TO USE THIS SITE, OR ANY ERRORS OR OMISSIONS IN THE CONTENT OF THE SITE. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you. Novartis AG also assumes no responsibility, and shall not be liable for, any damages to, or viruses that may infect, your computer equipment or other property on account of your access to, or use of the Information. Novartis AG reserves the right to discontinue this Site at any time without notice and without liability.

6. Information you supply to us

Except for information covered by our Privacy Policy, any communication or material you transmit to the Site by electronic mail or otherwise, including any data, questions, comments, suggestions or the like is, and will be treated as, non-confidential and nonproprietary. Anything you transmit or post becomes the property of Novartis AG or its affiliates and may be used for any purpose, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and posting. Furthermore, Novartis AG is free to use, without compensation to you, any ideas, concepts, know-how, or techniques contained in any communication you send to the Site for any purpose whatsoever including, but not limited to, developing, manufacturing and marketing products using such information.

7. Worldwide products

This Site may contain information on worldwide products and services, not all of which are available in every location. A reference to a product or service on this Site does not imply that such product or service is or will be available in your location. The products referred to on this Site may be subject to different regulatory requirements depending on the country of use. Consequently, visitors may be notified that certain sections of this Site are intended only for certain kinds of expert users or only for audiences in certain countries. You should not construe anything on this Site as a promotion or advertisement for any product or for the use of any product that is not authorized by the laws and regulations of your country of residence.

8. Disclaimer

Nothing on this Site constitutes an invitation or offer to invest or deal in the securities or American Depositary Receipts of Novartis. In particular, actual results and developments may be materially different from any forecast, opinion or expectation expressed on this Site and the past performance of the price of securities must not be relied on as a guide to their future performance.

9. Links to this site

Novartis AG has not reviewed any or all of the third-party websites which contain links to this Site and is not responsible for the content of any such off-site pages or any other sites linked to the Site. If you wish to link your website to this Site, you may only link to the home page. You may not link to any other pages within this Site without the prior written consent of Novartis AG. Quotation or use of one or more portions of this Site in the site of any third parties without written consent is likewise prohibited.

10. Links to other sites

Links to third-party sites may be provided for the interest or convenience of visitors to this Site. We will endeavor to inform you when you are leaving this Site that the terms of use and privacy policy of the third-party site may be different. However, Novartis AG accepts no liability for links from us to others, and in particular we are not responsible for the accuracy or legality of the content thereof. We accept no liability deriving from a breach or omission in the privacy policies of third parties.

11. Postings to this site

Although Novartis AG may from time to time monitor or review discussions, chats, postings, transmissions, message boards, and the like on the Site, Novartis AG is under no obligation to do so and assumes no responsibility or liability arising from the content of any such locations nor for any error, defamation, libel, slander, omission, falsehood, promotional materials, obscenity, pornography, profanity, danger, privacy disclosure or inaccuracy contained in any information within such locations on the Site. You are prohibited from posting or transmitting any unlawful, promotional, threatening, libelous, defamatory, obscene, scandalous, inflammatory, pornographic, or profane material or any material that could constitute or encourage conduct that would be considered a criminal offense, give rise to civil liability, or otherwise violate any law. Novartis AG will fully cooperate with any law enforcement authorities or court order requesting or directing Novartis AG to disclose the identity of anyone posting any such information or materials.

12. Consequences

If we become aware that you have violated any of the terms and conditions contained in this Legal Statement, we may immediately take corrective action, including preventing the user from using the services offered by Novartis AG and removing any information, data and content put on the Site by the user, at any moment and without notice. If we have been injured by your violation we may, in our sole discretion, seek to recover damages from you.

13. Revisions

Novartis AG may at any time revise these Terms and Conditions by updating this posting. You are bound by any such revisions and should therefore periodically visit this page to review the then current Terms and Conditions to which you are bound.

Most common adverse reactions in the FREEDOMS trial (%) §

  GILENYA (n=425) placebo (n=418)
Upper respiratory tract infection 49.9 50.5
Headache 25.2 23.0
Abnormal liver function test 15.8 5.0
Influenza virus infection 12.9 9.8
Diarrhoea 11.8 7.4
Back pain 11.8 6.9
Fatigue 11.3 10.8
Cough 10.1 8.1
Urinary tract infection 8.0 11.2

§Occurring in ≥10%.

Safety data presented are placebo-controlled and refer to 0.5 mg/day.

Additional areas for consideration:

Liver transaminases: In clinical trials, treatment with GILENYA was associated with asymptomatic liver transaminase elevations of 3x the upper limit of normal (ULN) in 8% of patients and of 5x ULN in 2% of patients. A majority of these occurred within the first 12 months, although they can occur at any time during treatment with GILENYA.

Macular oedema: In clinical trials, 0.4% of patients treated with GILENYA developed macular oedema, predominantly in the first 3-4 months.

Bradyarrhythmia: Initiation of GILENYA treatment results in a transient decrease in heart rate, maximal at 4-5 hours, and may also be associated with atrioventricular conduction delays.

Infections: GILENYA may increase the risk of infections.

Blood pressure: In clinical trials, GILENYA was associated with an average increase of ~2 mm Hg in systolic and ~1 mm Hg in diastolic pressure after approximately 2 months of treatment.

Pregnancy/breastfeeding: Women of childbearing potential should be counseled about the risk for foetal harm with GILENYA and the need for effective contraception during treatment and for 2 months after discontinuation. Women receiving GILENYA should not breastfeed.

GILENYA should not be used in:

The European Medicines Agency is undertaking a review of the benefits and risks of Gilenya following concerns over its effects on the heart after the first dose. While the review is ongoing, the Agency’s Committee for Medicinal products for Human Use (CHMP) is advising doctors to increase the level of monitoring of patients after the first dose. Please click on the link to Prescribing Information in the upper right hand corner of this page for more information.

Reference: 1. Kappos L, Radue E-W, O'Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387-401.

See Prescribing information

*INDICATION

Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following adult patient groups:

- Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (refer to EU Product Information for exceptions and information about washout period). 

- Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI. 

Numbers estimated as of August 2015. Data on file.

Includes doses ranging from 0.5-5 mg/day. GILENYA 0.5 mg/day is the only approved dose.

#Planned recruitment targets