Privacy Policy

Data protection

Merz attaches great importance to the protection of personal data. In the following data protection information, we inform you about who is responsible for the processing of your data (see section A). Further information is provided depending on the particular capacity in which you contact us, for example whether you are a visitor to our website or a customer of our products (see section B). In addition, you will receive general information on the processing of your data by Merz, in particular regarding sharing of your data, the data retention period and your rights in relation to the processing of your data (see sections C. to G.).

Merz processes your data in accordance with the data protection regulations of the German Federal Data Protection Act (“BDSG”) in the version in force from 25 May 2018 and Regulation (EU) 2016/679 (General Data Protection Regulation – “GDPR”).

A. CONTROLLER FOR THE PROCESSING OF YOUR PERSONAL DATA

Controller for the processing of your personal data within the meaning of Art. 4 No. 7 GDPR is Merz Therapeutics GmbH (“Merz”, “we”, “us”, “our”), a member of the Merz group of companies, given as contact address in the imprint or through direct communication with you.

B. DATA PROCESSING IN DIFFERENT PROCESSING CONSTELLATIONS

I. Visitors to our websites

  1. What data is collected and processed when you visit the Merz websites?
    When the Merz websites are accessed, the Merz servers automatically store various data about the system accessing the site. This includes the type of browser used, the browser version, the operating system used, the website from which the Merz website is accessed, the subpages of the Merz website accessed, the date and time of access, the Internet protocol address (IP address), the Internet service provider and data that is comparable with this data. Merz uses this data to enable access to the website and to identify and correct any technical problems that may occur. The legal basis for the processing of personal usage data for this purpose is Art. 6 para. 1 sentence 1 lit. (b) GDPR. Merz further uses this data to prevent and, if necessary, tackle misuse of Merz products and services. In addition, Merz uses this data in anonymized form, i.e. without the capability of identifying the user, for statistical purposes and to improve the websites. The legal basis for this processing of personal usage data is Art. 6 para. 1 sentence 1 lit. (f) GDPR.
  2. What data is processed in areas with restricted access?
    Certain areas of the Merz websites are accessible to medical professionals only and require prior registration. As part of the registration process, the user must provide certain information, such as username, e-mail address, etc. Merz uses this information solely for the purpose of setting up and managing the user account, identifying authorized users and in order to be able to make the desired function available to the user. The legal basis for the processing of the data described above is Art. 6 para. 1 sentence 1 lit. (b) GDPR.
  3. How are cookies used?
    The Merz websites use cookies. Cookies are small text files that are stored on the user’s data carrier and exchange certain settings and data with the Merz system via the browser. A cookie usually contains the name of the domain from which the cookie data was sent, information about the age of the cookie, and an alphanumeric identifier. As far as the cookies are technically necessary to operate our websites and to enable users to use its functions, the legal basis for using such cookies is Art.6 para. 1 sentence 1 lit. (b) GDPR.

    Bitte aktivieren Sie Javascript, um die Liste aller deklarierten Cookies und ähnlicher Techniken zu sehen.
  4. LinkedIn Insight Tag
    This website of Merz Therapeutics GmbH (“Merz”, “we”) uses LinkedIn Insight Tag, a service of LinkedIn Ireland Unlimited Company, Gardner House, Wilton Plaza, Dublin 2, Ireland (“LinkedIn”).The LinkedIn Insight Tag, a conversion tracking cookie, is used if the user has reached our website via LinkedIn. In this way, we can recognise that the user has interacted with our ad and has been redirected to our website.LinkedIn collects the URL, referrer, IP address, information about your device and browser (user agent), time of access and your usage behaviour on our website. We receive aggregated anonymised reports on the demographics of our target audience and the performance of our ads and can draw conclusions for our products. We also have the ability to retarget, which allows us to display targeted ads outside of our website. For more information on how LinkedIn processes your data, please see LinkedIn’s privacy policy at: https://de.linkedin.com/legal/privacy-policy?.LinkedIn also transfers personal data to the US and other third countries outside the European Economic Area that are not covered by an adequacy decision of the EU Commission. Corresponding information can be found at: https://www.linkedin.com/help/linkedin/answer/62533?trk=microsites-frontend_legal_privacy-policy&lang=de. Accordingly, LinkedIn regularly uses the standard data protection clauses approved by the EU Commission in accordance with Art. 46 para. 2 lit. c GDPR. The collected data is transferred to LinkedIn servers and stored there for 90 days.The legal basis for the processing is the consent of the user pursuant to Art. 6 para. 1 sentence 1 lit. a GDPR.As a user, you have the option to revoke your consent at any time with future effect by adjusting your cookie settings. Alternatively, you can change your settings at any time via the link “Cookie settings”. You will find the link in the footer on our website.You can prevent the collection of the data generated by the cookies and related to your use of the website, as well as the processing of this data by LinkedIn, by declaring your withdrawal to LinkedIn using the following link https://www.linkedin.com/psettings/guest-controls/retargeting-opt-out. As a LinkedIn member, you can control the use of your data for advertising purposes via your account settings at the following link: https://www.linkedin.com/psettings/advertising/actions-that-showed-interest.
    Joint Controllership of Merz and LinkedIn Ireland Unlimited Company for the use of LinkedIn Insights.
    In order to better assess the success of our LinkedIn presence, to evaluate interactions on our page and in our group and to draw conclusions about our reach, we can access various statistical values using the LinkedIn Insights tool.In this context, Merz and LinkedIn Ireland Unlimited Company act as joint controllers within the meaning of Art. 26 GDPR. For this purpose, we have concluded a Joint Controller Agreement with LinkedIn pursuant to Art. 26 GDPR. You can view the content of the agreement and the division of responsibilities between Merz and LinkedIn Ireland Unlimited Company at https://legal.linkedin.com/pages-joint-controller-addendum.
  5. How is Matomo used?
    With your consent, we also use the web analytics service Matomo (formerly Piwik) from InnoCraft Ltd., 150 Willis St, 6011 Wellington, New Zealand, NZBN 6106769 („Matomo“) on our website. Matomo uses cookies for analysing the usage of the website. The information generated by the cookies about the use of this website is stored on servers of Matomo located in the European Union. The cookies collect the following information about the users: Usage data (e.g. websites visited, interests in content, times of access), location (country, region, city) and meta / communication data (e.g. information about the device and browser, IP address). The IP address of the user is anonymized before storage. The cookies used by Matomo expire after 13 months at the latest. You can find further information about the data processing performed by Matomo under https://matomo.org/privacy-policy/. The legal basis for the processing of personal data via the use of the web analytics service Matomo is the user’s consent, Art. 6 para. 1 sentence 1 lit. (a) GDPR. The user can withdraw his / her consent at any time. The cookies placed by Matomo can be deactivated or deleted if the user adapts the cookie settings of his / her browser or deactivates marketing cookies in the cookie settings on our website.
  6. Watching Vimeo videos
    Videos from Vimeo are embedded on our websites. The Vimeo service is operated by Vimeo, Inc. 555 West 18th Street, New York, New York 10011, USA (“Vimeo”). When the user visits one of our pages on which a video is embedded via Vimeo, and the user has given us prior consent to the use of marketing cookies, a connection is established to the Vimeo servers. At the same time, the IP address, technical information (e.g. browser type, operating system, information to the end user device and its settings) and other data required for the service, as well as the information that the user has visited a specific page of our website and how he / she has interacted on this site, are transmitted to Vimeo. If the user interacts with the video (e.g. if the user clicks on the play button), this data is also transmitted to Vimeo. If the user has an account with Vimeo and is logged in at the time of his / her visit to our website, Vimeo can match the user’s browsing activity to his / her user account with Vimeo. The cookies used by Vimeo are stored for no longer than two years. Further information on data processing by Vimeo can be found at https://vimeo.com/privacy. The legal basis for the processing of personal data when using videos embedded via Vimeo is the consent of the user, Art. 6 para 1 sentence 1 lit. (a) GDPR. The user can withdraw his / her consent at any time. The cookies set by Vimeo can be deactivated or deleted by the user changing the cookie settings of his / her browser or deactivating marketing cookies in the cookie settings on our website.
  7. How long will my personal data be stored?
    Personal data of visitors to our website will be deleted when their data is no longer required for the purposes described above, unless longer storage is required by law. Usage data in the meaning described in Section B.I.1 above is regularly stored for a period of seven days. Cookies that are necessary for the operation of our website from a technical perspective are stored for a period of up to one year.

II. Adverse event reports from customers

We are grateful if you report to us any adverse reactions to our products. Such reports are of vital importance as regards public health. If you believe that you have experienced an adverse event while using one of our products, please let us know.

When you contact us, we may collect and process various (health) data relating to you. This includes, for example, information about the incident, age, gender, etc. The sole purpose of providing this data is to help us investigate the incident. For this purpose, your data will be passed on to Merz Therapeutics GmbH, which is responsible for the central administration of incoming adverse event reports within the Merz companies (with the exception of the Merz companies in the USA). Merz Therapeutics GmbH submits all adverse event reports from Europe to the European Medicines Agency. Where required by law, the data will also be shared with other competent authorities. The legal basis for the processing of the data is Art. 6 para. 1 sentence 1 lit. (c) GDPR and Art. 9 para. 2 lit. (i) GDPR.

The adverse reaction reports shall be kept [for at least 10 years for public health reasons] after the product has ceased being marketed in any country.

C. PROCESSING WHEN DIRECT CONTACT IS MADE WITH MERZ (E.G. USING CONTACT FORM OR BY E-MAIL)

When you contact Merz, e.g. using a contact form on a website or by e-mail, the personal data you provide to Merz, e.g. e-mail address, name, content of the inquiry, etc., will be used exclusively for processing the particular inquiries. Your data may be passed on to other Merz companies if and to the extent necessary to respond to your inquiry.

The legal basis for the processing of the data described above is, depending on the content of the respective contact, Art. 6 para 1 sentence 1 lit. (b) or (f) GDPR. The sharing of data with other Merz companies for internal administrative purposes is also based on Art. 6 para 1 sentence 1 lit. (f) GDPR. Insofar as data is to be transferred to Merz companies outside of the European Union or the European Economic Area in order to respond to the inquiry, and if the Merz company is located in a country for which the European Commission has not decided that this country ensures an adequate level of data protection, the necessary guarantees for the protection of personal data are contained in the standard contractual clauses adopted by the European Commission. These can be viewed here: https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/standard-contractual-clauses-scc/standard-contractual-clauses-international-transfers_en.

D. DISCLOSURE OF PERSONAL DATA TO (OTHER) THIRD PARTIES

For the technical processing of personal data, Merz is supported by specialized technical service providers. These service providers are carefully selected and are legally and contractually obligated to ensure a high level of data protection. The legal basis for the cooperation with these service providers is Art. 28 GDPR.

Merz will only pass on personal data to third parties for purposes other than those mentioned in this data protection notice if there is a legal obligation to do so (Art. 6 para 1 sen-tence 1 lit. (c) GDPR) or if you have given your express consent (Art. 6 para 1 sentence 1 lit. (a) GDPR).

If personal data is transferred by us to parties outside the European Union or the European Economic Area, these are either in a country for which the European Commission has decided that this country ensures an adequate level of data protection, or an adequate level of data protection is established by standard contractual clauses approved by the European Commission and concluded between us and the respective party. The standard contractual clauses can be viewed here: https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/standard-contractual-clauses-scc/standard-contractual-clauses-international-transfers_en.

E. DURATION OF THE RETENTION OF YOUR DATA

Unless otherwise specified in this data protection notice, personal data will be deleted by Merz when it is no longer needed for the purposes for which it was processed and legal retention periods have expired. Contract-relevant data will be kept for up to ten years after termination of the respective contract with Merz.

F. RIGHTS IN RELATION TO PROCESSING

If you would like detailed information about or a copy of the personal data Merz has stored about you, you can contact Merz. You may also receive the data that you have provided to Merz in a structured, commonly used and machine-readable format in accordance with legal requirements, or you may request that Merz transfers this data to a third party. Should you discover that the personal data stored about you is incorrect or incomplete, you may at any time request that this data be corrected or completed without delay. Under the conditions specified in Art. 17 and 18 GDPR, you may also demand the deletion or restriction of the processing of personal data. If you have declared your consent to the processing of your personal data, you have the right to withdraw your consent at any time without affecting the lawfulness of the processing carried out on the basis of the consent until its withdrawal.

You also have the right to lodge a complaint with the competent data protection supervisory authority.

Insofar as the processing of your personal data is based on our legitimate interests within the meaning of Art. 6 para 1 sentence 1 lit. (f) GDPR, you have the right to object to the processing of personal data concerning you at any time for reasons related to your particular situation; this also applies to any profiling based on this provision. Merz will then no longer process the personal data, unless Merz can demonstrate compelling legitimate grounds for the processing which override your interests, rights and freedoms, or the processing serves the purpose of establishing, exercising or defending legal claims.

G. CONTACT INFORMATION

If you have any questions regarding the processing of personal data by Merz or if you wish to exercise your rights with respect to such processing, you may contact Merz at any time. For this purpose, it is sufficient to send a notification to:

Merz Therapeutics GmbH
Data protection
Eckenheimer Landstrasse 100
60318 Frankfurt am Main
Germany
Merz’s data protection officer can be contacted at dataprotection@merz.com.

In addition, we refer to our Merz Data Protection Notice in which we provide general information about the processing of personal data in various constellations (for example, whether you contact us as a visitor to our website, as a study participant, as a customer of our products or as a healthcare professional) (https://merztherapeutics.com/fin).

Hepa-Merz® – Summary of prescribing information

Hepa-Merz® Granules. Composition: One sachet with 5 g of Granules contains: Active substance: 3 g L-ornithine- L-aspartate. Excipients: citric acid, aspartame (E951), povidone 25, fructose, flavorings, orange yellow S (E110). Note for diabetics: One sachet of Hepa-Merz® Granules contains 1.13 g of fructose (corresponds to approx. 0.11 BU). Therapeutic indications: Treatment of concomitant disease and sequelae due to impaired detoxification activity (e.g. in cirrhosis of the liver) with the symptoms of latent and manifest hepatic encephalopathy. Contraindications: Absolute: Hypersensitivity to L-ornithine-L-aspartate, orange yellow S or any of the other excipients. Severely impaired renal function (renal insufficiency). A serum creatinine value over 3 mg/100 ml can be used as a guideline value. Relative: Pregnancy and lactation: No clinical data are available relating to intake of Hepa-Merz® Granules in children and during pregnancy. No exhaustive animal studies have been performed for L-ornithine-L-aspartate, to investigate its toxicity in relation to reproduction. Administration of Hepa-Merz® Granules during pregnancy should therefore be avoided. If, however, treatment with Hepa-Merz® Granules is considered necessary, careful consideration should be given to the benefit versus risk ratio. It is not known whether L-ornithine-L-aspartate is excreted into the breast milk. Administration of Hepa-Merz® Granules should therefore be avoided during lactation. If, however, treatment with Hepa-Merz® Granules is considered necessary, careful consideration should be given to the benefit versus risk ratio. No data regarding fertility. Undesirable effects: Uncommon (³ 1/1,000 to < 1/100): Nausea, vomiting, stomach ache, flatulence, diarrhea. Very rare (< 1/10,000): Pain in the limbs. These undesirable effects are usually transient and do not require withdrawal of the medicine. Orange yellow S (E110) can trigger allergic reactions. Warnings: Hepa-Merz® Granules contain fructose. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Aspartame (E951): Contains a source of phenylalanine. May be harmful for people with phenylketonuria. Further precautions: As a result of the disease, the ability to drive and operate machinery may be impaired during treatment with L-ornithine-L-aspartate.

Hepa-Merz® Granules. Composition: One sachet with 5 g of Granules contains: Active substance: 3 g L-ornithine- L-aspartate. Excipients: citric acid, saccharin sodium, sodium cyclamate, povidone 25, fructose, flavorings, orange yellow S (E110). Note for diabetics: One sachet of Hepa-Merz® Granules contains 1.13 g of fructose (corresponds to approx. 0.11 BU). Therapeutic indications: Treatment of concomitant disease and sequelae due to impaired detoxification activity (e.g. in cirrhosis of the liver) with the symptoms of latent and manifest hepatic encephalopathy. Contraindications: Absolute: Hypersensitivity to L-ornithine-L-aspartate, orange yellow S or any of the other excipients. Severely impaired renal function (renal insufficiency). A serum creatinine value over 3 mg/100 ml can be used as a guideline value. Relative: Pregnancy and lactation: No clinical data are available relating to intake of Hepa-Merz® Granules in children and during pregnancy. No exhaustive animal studies have been performed for L-ornithine-L-aspartate, to investigate its toxicity in relation to reproduction. Administration of Hepa-Merz® Granules during pregnancy should therefore be avoided. If, however, treatment with Hepa-Merz® Granules is considered necessary, careful consideration should be given to the benefit versus risk ratio. It is not known whether L-ornithine-L-aspartate is excreted into the breast milk. Administration of Hepa-Merz® Granules should therefore be avoided during lactation. If, however, treatment with Hepa-Merz® Granules is considered necessary, careful consideration should be given to the benefit versus risk ratio. No data regarding fertility. Undesirable effects: Uncommon (³ 1/1,000 to < 1/100): Nausea, vomiting, stomach ache, flatulence, diarrhea. Very rare (< 1/10,000): Pain in the limbs. These undesirable effects are usually transient and do not require withdrawal of the medicine. Orange yellow S (E110) can trigger allergic reactions. Warnings : Hepa-Merz® Granules contain fructose. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Further precautions: As a result of the disease, the ability to drive and operate machinery may be impaired during treatment with L-ornithine-L-aspartate.

Hepa-Merz® Infusion concentrate. Composition: One ampoule of 10 ml contains: Active substance: 5 g L-ornithine-L-aspartate. Excipients: Water for injections. Therapeutic indications: Latent and manifest hepatic encephalopathy. Contraindications: Absolute: Hypersensitivity to L-ornithine-L-aspartate. Severe renal impairment (renal failure). A serum creatinine level in excess of 3 mg/100 ml can be taken as a guide. Relative: Pregnancy and lactation: There are no clinical data available on the use of Hepa-Merz® Infusion concentrate in children and during pregnancy. L-ornithine L-aspartate has been investigated for reproduction toxicity only to a limited extent in experimental animal studies. The administration of Hepa-Merz® Infusion concentrate in pregnancy should therefore be avoided. If treatment with Hepa-Merz® is nevertheless thought to be necessary, the benefits and risks should be carefully assessed. It is not known whether L-ornithine-L-aspartate passes into breast milk. Administration of Hepa-Merz® should therefore be avoided during lactation. If treatment with Hepa-Merz® is nevertheless thought to be necessary, the benefits and risks should be carefully assessed. No data regarding fertility. Undesirable effects: Uncommon (³ 1/1,000 to < 1/100): Nausea. Rare (³ 1/10,000 to < 1/1,000): vomiting. Frequency not known (frequency cannot be estimated from the available data): hypersensitivity, anaphylactic reaction. Generally however, the gastrointestinal symptoms are transient, and do not necessitate discontinuation of treatment. They disappear on reduction of the dose or the infusion rate. Further precautions: Hepa-Merz concentrate for solution for infusion can be mixed with the usual infusion solutions. So far, no peculiarities have been observed with regard to miscibility. However, the ampoules should be admixed to the infusion solution only immediately before application. At high doses of Hepa-Merz® Infusion concentrate, serum and urine urea levels should be monitored. If liver function is substantially impaired, the infusion rate must be adjusted to the individual patient in order to prevent nausea and vomiting. Depending on the underlying disease, the ability to drive and operate machines may also be impaired on treatment with L-ornithine L-aspartate. Hepa-Merz® Infusion concentrate must not be injected into an artery. Status: January 2016. Merz Pharmaceuticals GmbH, 60048 Frankfurt.