Drug safety

Our top priority is that our medicinal products are safe. 

Therefore,

  • continuous improvements regarding the use,
  • comprehensive information about our medicinal products and
  • tracking and following up on adverse reactions

are an important concern for us.

On these pages, you will find important information about drug safety. If you have any further questions about the use of our medicinal products or adverse drug reactions (ADRs), please do not hesitate to ask us.

We are legally obliged to - and in the interest of a high degree of drug safety strive to - assess each case of a suspected adverse drug reaction. For this purpose, it is required that you precisely document your observations whenever adverse drug reactions occur and that you furthermore tell us which medicines you are taking and which underlying and concomitant disorders you have.

The purpose of the following information is to provide you with further instructions and support

Which adverse drug reactions (ADRs) are important and must be reported?

Depending on whether an adverse drug reaction is labelled in the Patient Information Leaflet, we differentiate between expected and unexpected drug reactions. In general, we are interested in any ADR reports, and in particular those that are not labelled in the Patient Information Leaflet or have an unexpectedly severe course.

However, please do note that reporting the ADR must not replace a visit to the doctor under any outcome.

Whom can I contact in a case of an adverse drug reaction?

Whom can I contact in a case of an adverse drug reaction?

You can report suspected adverse reactions directly to us:

APOGEPHA Arzneimittel GmbH
Drug Safety Department
E-Mail: Pharmacovigilance

or via the national reporting system to the

Federal Institute for Drugs and Medical Devices
Pharmacovigilance Department:

Bundesinstitut für Arzneimittel und Medizinprodukte
Abt. Pharmakovigilanz
Kurt-Georg-Kiesinger Allee 3
D-53175 Bonn

Website: www.bfarm.de

How should a suspected adverse drug reaction be reported?

For your report, please use our standardized report form for adverse drug reactions (147 KB). If you want to report adverse drug reactions directly to the Federal Institute for Drugs and Medical Devices, please use the form provided on the authority's website.

What will happen then with these reports to APOGEPHA?

Your report will be documented in our drug safety database and assessed by a doctor or pharmacist. In order to be able to perform a thorough assessment of the suspected adverse drug reaction, queries may arise. In this context, it may be helpful if you provide us with lab findings or hospital reports. We will in any case inform you about the result of our assessment We are legally obliged to notify the competent authorities of adverse drug reaction reports. This notification will be in pseudonymized form; only the patient's initials will be shared, no contact Details Our drugs undergo regular benefit-risk assessments based on the reports from patients, doctors and scientific publications. If required, risk minimization measures are initiated. These may for instance also include updating the product information by including new adverse drug reactions, contraindications or warnings.

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