Data Protection Policy

As operator of this website, we also process certain personal data. This might – unintentionally – occur with regard to persons residing within the European Union, leading to the applicability of the General Data Protection Regulation (GDPR). If not indicated to the contrary, the terms and definitions of the GDPR will be used in this policy.

This document is meant to give you an overview of the data processing activities, your rights as a data subject and other important information. You may access, print and/or save this document at any time.

I.​ Who we are

We are a German private limited liability company engaged in the research, development and commercialization of PET tracers for certain biomarkers, e.g. amyloid plaques for the detection of Alzheimer’s disease. As such, the person responsible for the data processing on this website is:

Life Molecular Imaging GmbH, represented by the Managing Directors Dr. Ludger Dinkelborg and Michel Jongens, registered business address at Tegeler Str. 6-7, 13353 Berlin, Germany.

We are registered with the German Trade Register at the District Court of Berlin-Charlottenburg under no. HRB 136823 B. You may contact us by phone (+49 30 461 124603) or via email (info[at]life-mi.com).

II.​ General Data Usage

The use of this website generally and easily is possible without directly providing any personal data. There are some exceptions to that rule:

II.1 ​Internal Section

The internal section of our website is intended for certain groups of persons in the United States and can only be accessed after registering. Following such registration, you may log in to this internal section by providing the username and password you chose during registration.

Further information regarding this registration process and the data processed can be found in this internal section.

II.2 Contact Form

You may also use the contact form provided by this website if you intend to get in contact with us. Here, we collect certain data that is needed to reply to you and to answer your requests.

II.3 Usage Data

Then there is data we collect and process in order to enable and ease the use of this website. This is mostly of technical nature, such as the IP address of users accessing this website.

II.4​ Cookies

We use cookies on our website. These are, in effect, small data files placed on a visitor’s browser and by which it is possible to recognize this device when other websites are called or when the user returns to this website. The use of cookies can identify a user; it is considered to be personal data. That being said, we use cookies for and from Google Analytics, LinkedIn and Drupal. You may choose to reject these cookies so that you opt out of their use. Otherwise, you consent to their use. For additional details, please see below section IV.1.

III.​ Special Categories of Data

We do not process any data of the special categories enumerated in Article 9 GDPR.

IV.​ Data Processing in Detail

Throughout all data processing on this website, we strictly adhere to the principles of data minimization and purpose limitation. This means that we only collect the data that is necessary to achieve the intended effect, and that all data is processing in accordance with the purpose it has been collected for. In all cases, there is an appropriate legal justification given for the processing in question.

IV.1​ Certain Processing Situations

With regard to the processing situations outlined above, this means the following:

Insofar the internal section is accessed, we refer to that section and the specific Data Protection Policy to be found there. Lawfulness of processing results from your consent (Article 6 no. 1 lit. a) GDPR).

Contact data is collected and processed when you use the contact form. We ask you to provide us with an email address, a phone number and your name and surname. This is needed to get back to you with the requested information. Again, your consent serves as the legal basis for this processing.

As for the collection of usage data, we limit such processing to the extent that is absolutely necessary. This concerns the (shortened) IP address of the device you are accessing our website from, the browser type and version you are using, your time zone settings, details on your browser plug-ins, and the operating system you use. We need this information to deliver the contents of this website in a version that is suited best for the equipment you use, i.e. adapted to your screen resolution and making use of specific features of your browser application. As detailed above and below, this data is anonymized.

Generally speaking, the lawfulness of this data processing is based on a legitimate interest (enabling and providing the best possible user experience by anonymization) in accordance with Article 6 no. 1 lit f) GDPR.

This data is stored on our servers, but only insofar as the IP address is shortened and stripped of any personal data it might contain and then cannot be traced back to a specific place, device or person anymore. As anonymous data, it is not subject to the GDPR anymore. The de-identification and anonymization itself constitutes processing of data that is – up to that point – personal data. The legal basis here is also our legitimate interest, taking into account that any contravening interest of a data subject does not exist.

Cookies are used and the respective data is collected and processed, unless you choose to opt out of their use. We refer to the respective Cookie Policies of Drupal and LinkedIn:

https://drupal.docs.cern.ch/cookie-policy/

https://www.linkedin.com/legal/cookie-policy

We use some services of Google Analytics. Yet this does not concern personal data as only shortened IP addresses and therefore anonymized data is transmitted.

IV.2​ Cross-Border Data Transmission

We do not transfer any personal data into third countries outside the European Union.

IV.3 ​Transfer to Third Parties

We do not sell any personal data to any third party.

V.​ Your Rights

As the data subject, you have the right to:

  • Withdraw your consent: If and to the extent that processing of your personal data is based on consent, you have the right to withdraw that consent without cause at any time by contacting us via any of the means mentioned on this website;
  • Be informed by us about your personal data processed by us;
  • Request the rectification of incorrect data or the deletion of your personal data;
  • Request that we restrict the processing of your personal data; and
  • Data portability, i.e. receiving your personal data in a structured, commonly used and machine-readable format.

You have the right to complain to a data protection supervisory authority about our processing of your personal data. For more information, please contact the local Berlin data protection authority:

Berliner Beauftragte für Datenschutz und Informationsfreiheit 

Alt-Moabit 59-61, 10555 Berlin, Germany 

Tel.: +49 30 13889-0 / Fax: +49 30 2155050 / mailbox[at]datenschutz-berlin.de

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:  Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline, and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.

 

NEURACEQ IMPORTANT SAFETY INFORMATION:

 

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

  • Risk for Image Misinterpretation and other Errors
    NEURACEQ Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. [see Section 5.1 of the full prescribing information]
  • Radiation Risk
    NEURACEQ, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration in the full prescribing information].

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/application site erythema (1.7%), and injection site irritation (1.1%).

USE IN SPECIFIC POPULATIONS:

  • Pregnancy : All radiopharmaceuticals, including NEURACEQ, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering NEURACEQ administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation : Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for 24 hours after NEURACEQ administration.
  • Pediatric Use:  The safety and effectiveness of NEURACEQ have not been established in pediatric patients.
  • Geriatric Use: No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.

OVERDOSAGE:
 In the event of administration of a radiation overdose with NEURACEQ, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to NEURACEQ administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS: please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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