IDEOGEN Group GmbH
Version 1.0 | March 2026
This Pharmacovigilance and Medical Information Disclaimer ("Disclaimer") explains IDEOGEN Group GmbH's obligations and practices in relation to pharmacovigilance and the medical information provided on this website. It also explains the rights and responsibilities of users who access medical or pharmaceutical information on www.ideogen.com.
If you are experiencing a medical emergency, call your local emergency services immediately. Do not use this website to seek emergency medical assistance.
IDEOGEN Group GmbH, as a holder of licences for the importation, exportation, and wholesale distribution of medicinal products, and as a company involved in marketing authorisations and managed access programs for pharmaceutical products in Switzerland, the European Union, and other jurisdictions, is subject to pharmacovigilance (PV) obligations under the following primary regulatory frameworks:
Switzerland:
(a) Swiss Therapeutic Products Act (TPA/HMG), Bundesgesetz über Arzneimittel und Medizinprodukte, SR 812.21, as amended — in particular the provisions requiring marketing authorisation holders and distribution licence holders to establish pharmacovigilance systems, collect adverse event reports, and notify Swissmedic of reportable safety events;
(b) Ordinance on Adverse Events (TAMV), Verordnung über die Meldung von unerwünschten Ereignissen bei Heilmitteln, SR 812.213.3, which governs the content, format, and timing of adverse event notifications to Swissmedic; and
(c) **Swissmedic Guidelines on Pharmacovigilance**, including requirements for safety signal detection, periodic safety update reports (PSURs), risk management plans (RMPs), and urgent safety restrictions.
European Union (applicable to IDEOGEN's EU operations through its subsidiaries):
(d) **EU ** amending on the Community code relating to medicinal products for human use with regard to pharmacovigilance — establishing the strengthened EU pharmacovigilance framework, including requirements for the EudraVigilance database, risk management systems, and healthcare professional and patient reporting;
(e) **** amending Regulation (EC) No 726/2004 as regards the pharmacovigilance of medicinal products for human use — applicable to centrally authorised products and establishing uniform requirements across EU member states;
(f) Commission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC; and
(g) ** Guidelines on (GVP)** — the authoritative European guidelines on pharmacovigilance practice.
Advanced Therapy Medicinal Products (ATMPs):
(h) **** on advanced therapy medicinal products, as applicable to IDEOGEN's handling of cell therapies and ATMPs, which imposes enhanced pharmacovigilance and traceability requirements, including a minimum data retention period of thirty (30) years from expiry of the product's shelf life.
IDEOGEN maintains a pharmacovigilance system in accordance with applicable legal requirements. IDEOGEN's pharmacovigilance function is managed on its behalf by:
APCER Life Sciences A globally active pharmacovigilance service provider operating on behalf of IDEOGEN.
All adverse event reports and pharmacovigilance communications received by IDEOGEN (whether through this website, by email, by telephone, or in person) are forwarded to APCER Life Sciences for processing, assessment, and regulatory reporting.
Healthcare professionals, patients, carers, and members of the public are strongly encouraged to report any suspected adverse reaction or safety concern in relation to any IDEOGEN product. Reporting is a vital contribution to ongoing post-market safety surveillance and protects patient and public health. Underreporting of adverse events is a recognised global challenge; every report is valuable.
You do not need to be certain that a product caused a reaction or event in order to file a report. Suspected associations are equally important.
You may report any of the following:
Adverse events, product quality complaints, and other safety information may be reported to IDEOGEN through the following channels:
IDEOGEN aims to acknowledge all pharmacovigilance reports within 24 hours of receipt.
In addition to, or as an alternative to, reporting to IDEOGEN, healthcare professionals and patients may also report directly to the relevant national competent authority:
IDEOGEN strongly encourages parallel reporting to both IDEOGEN and the relevant national authority.
To ensure that your report can be assessed and processed in accordance with regulatory requirements, IDEOGEN requests the following minimum information:
Minimum required:
Additional information that enhances report quality (not required but helpful):
The collection and processing of personal data — including health data (special category data under ) — submitted through pharmacovigilance reports is carried out by IDEOGEN on the basis of:
(a) Legal obligation ( and Article 9(2)(i)): Processing is necessary for compliance with IDEOGEN's legal pharmacovigilance obligations under the TPA/HMG (Switzerland), EU and (EU), and applicable national pharmaceutical legislation;
(b) Substantial public interest (GDPR Article 9(2)(i) and equivalent provisions under Swiss nFADP): Processing of health data for pharmacovigilance purposes serves a substantial public interest in pharmaceutical safety and the protection of public health.
Personal and health data submitted through pharmacovigilance reports will be shared with:
(a) APCER Life Sciences: IDEOGEN's contracted pharmacovigilance service provider, acting as a data processor on IDEOGEN's behalf, who processes the data for regulatory compliance and signal detection purposes;
(b) ****: as required under Swiss TPA and applicable pharmacovigilance ordinances;
(c) ** and national competent authorities** within the EU: including through the EudraVigilance database, where IDEOGEN has reporting obligations in respect of EU-authorised or EU-distributed products;
(d) Other competent health authorities globally: where IDEOGEN has pharmacovigilance reporting obligations in relation to marketing authorisations or distribution licences in other jurisdictions (including but not limited to Turkey, MENA region, and CIS countries); and
(e) Other marketing authorisation holders or license partners: where a reportable adverse event relates to a product co-developed or co-licensed with another pharmaceutical company, and where regulatory obligations require information sharing.
Data sharing with competent authorities is conducted in accordance with applicable pharmacovigilance regulations and is not subject to the ordinary rules of personal data transfers, as such transfers are mandated by law.
Pharmacovigilance data, including personal data contained in adverse event reports, is retained in accordance with applicable regulatory requirements:
Data subjects who have provided personal data in connection with pharmacovigilance reports should note that:
(a) the exercise of rights to erasure, restriction, or objection may be limited under applicable law where the processing is required for the fulfilment of a legal pharmacovigilance obligation;
(b) IDEOGEN will, however, make every reasonable effort to respond to data subject requests and to anonymise or pseudonymise data where this is compatible with regulatory requirements; and
(c) full information on data subject rights and how to exercise them is available in IDEOGEN's Privacy Policy at www.ideogen.com.
For data protection enquiries in connection with pharmacovigilance: [email protected]
The medical and pharmaceutical information provided on this website is for general informational and educational purposes only. It does not constitute medical advice, professional medical diagnosis, treatment recommendations, or a substitute for consultation with a qualified healthcare professional. IDEOGEN is not a healthcare provider.
You should not rely on information obtained from this website as a basis for any medical decision, including decisions about diagnosis, treatment, or the prescribing of medicinal products. Always consult a qualified physician, pharmacist, or other licensed healthcare professional before making any medical decision or before beginning, modifying, or discontinuing any medical treatment.
Information about pharmaceutical products published on this website, including references to indications, dosage, route of administration, contraindications, and safety profiles, is provided for background informational purposes only. This information:
(a) may not correspond to the prescribing information or Summary of Product Characteristics (SmPC) approved in your jurisdiction;
(b) may reflect information from a jurisdiction other than your own;
(c) may not have been updated to reflect the most recent approved version of the SmPC; and
(d) does not replace or supersede the locally approved SmPC, patient information leaflet (PIL), or any guidance issued by your national competent authority.
Healthcare professionals must always consult the locally approved prescribing information (SmPC) for any IDEOGEN product before prescribing or dispensing.
IDEOGEN makes reasonable efforts to keep product information on this website current and accurate. However, product information may change following approval of label variations, updated risk management measures, or new safety findings. IDEOGEN cannot guarantee that all information published on this website reflects the most current approved product information at all times.
Certain sections of this website and the IDEOGEN Partner Platform contain information that is intended exclusively for healthcare professionals, including physicians, pharmacists, hospital pharmacists, clinical nurses, and other regulated healthcare professionals. This content may include:
(a) detailed clinical and scientific information about IDEOGEN products, including in-depth prescribing information, clinical study data, and managed access program criteria;
(b) materials intended to support evidence-based clinical decision-making;
(c) information about products that are not available to the general public; and
(d) information about managed access programs, compassionate use, or named patient supply, which is available only to qualified prescribers and authorised institutions.
By accessing any section of this website or the Partner Platform designated as restricted to healthcare professionals, or by requesting HCP-specific information, you confirm and warrant that:
(a) you are a licensed healthcare professional (physician, pharmacist, nurse, or other regulated healthcare professional) duly authorised to practise in your jurisdiction;
(b) you are authorised under applicable law in your jurisdiction to access detailed pharmaceutical prescribing information; and
(c) you will use any HCP-directed content solely for legitimate professional purposes in connection with your clinical practice or scientific research.
IDEOGEN reserves the right to verify professional status and to restrict access to HCP content where it cannot be satisfied of a user's professional qualification.
IDEOGEN's HCP-directed communications are conducted in accordance with:
(a) the (Verhaltenskodex der Pharmaindustrie Schweiz) of scienceindustries;
(b) Articles 31–32 of the Swiss Therapeutic Products Act (TPA/HMG), which regulate the advertising of therapeutic products to healthcare professionals;
(c) the EFPIA Code of Practice on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals; and
(d) applicable national codes of conduct in the jurisdictions in which IDEOGEN's subsidiaries operate.
Not all IDEOGEN products described on this website are available in all countries. Product availability is subject to:
(a) marketing authorisation or equivalent regulatory approval granted by the competent health authority in the relevant country;
(b) compliance with local import, wholesale distribution, and dispensing licensing requirements;
(c) national pricing and reimbursement decisions; and
(d) in the case of investigational or pre-approval products, eligibility under a managed access program, compassionate use program, or named patient supply arrangement.
IDEOGEN specialises in managed access programs, which enable eligible patients to access pharmaceutical products outside of standard commercial channels, typically prior to or in the absence of local marketing authorisation. Managed access through IDEOGEN is subject to:
(a) applicable national compassionate use, named patient supply, or hospital exemption legislation;
(b) approval from the relevant competent health authority or ethics committee, where required;
(c) execution of an applicable managed access program agreement or named patient supply agreement; and
(d) eligibility criteria established in consultation with the originator manufacturer and relevant regulatory authorities.
For information about whether a specific product is available through a managed access program in your jurisdiction, please contact IDEOGEN at [email protected].
References to products on this website do not constitute a guarantee or representation that any product is available for immediate supply or that any managed access program application will be approved. IDEOGEN's ability to supply any product is subject to supply chain conditions, regulatory authorisations, and commercial agreements.
In the event of a medical emergency — including any serious adverse event, suspected overdose, anaphylaxis, or other acute medical crisis — contact your local emergency services immediately:
Do not attempt to use the IDEOGEN website, pharmacovigilance report form, or IDEOGEN contact details as a substitute for emergency medical services.
If you are a healthcare professional with an urgent patient safety concern relating to an IDEOGEN product, please contact the IDEOGEN 24/7 safety hotline:
24/7 Safety Hotline: +800 22 44 77 00
For pharmacovigilance, medical information, and safety enquiries:
Postal Address:
IDEOGEN Group GmbH Pharmacovigilance / Medical Affairs Hurdnerstrasse 119 CH-8640 Hurden SZ Switzerland
Telephone: +41 43 311 52 52
IDEOGEN's pharmacovigilance function is managed by APCER Life Sciences on IDEOGEN's behalf. For regulatory purposes, APCER Life Sciences receives and processes all pharmacovigilance reports, maintains the pharmacovigilance database, and is responsible for regulatory submissions on IDEOGEN's behalf.
© 2013–2026 IDEOGEN Group GmbH. All rights reserved.
Version 1.0 — March 2026
