Drug safety
Our top priority is that our medicinal products are safe.
Therefore,
- continuous imprnvements 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. lf 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 disorder you have.
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 reaction. In general, we are interested in any ADR reports, and particular those that are not labelled in the Patient Information Leaflet or have an unexprectedly 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?
You can report suspected adverse reactions directly to us
APOGEPHA Arzneimittel GmbH
Drug Safety Department
E-Mail: Pharmakovigilanz
or via national reporting system to the
Federal Institute for Drugs and Mediacal Devices
Pharmacovigilance Department:
Bundesinstitut für Arzneimittel und Medizinprodukte
Abt. Pharmakovigilanz
Kurt-Georg-Kiesinger Allee 3
D-53175 Bonn
Website: www.bfarm.de
What happens to these reports at APOGEPHA afterwards?
Your report will be recorded in our drug safety database and assessed by a doctor or pharmacist. In order to be able to make a precise assessment of the side effect, there may be further questions. In this context, it is helpful if you provide us with laboratory findings or hospital reports. In any case, we will inform you of the result of our assessment.
We are legally obliged to report adverse drug reactions to the competent authorities. The report is made in pseudonymised form; only the patient's initials are passed on, but no contact details.
Based on the reports from patients, doctors and scientific publications, we subject our medicinal products to a regular risk-benefit assessment. If necessary, risk minimisation measures are initiated. This includes, for example, updating the product information by including new side effects, contraindications or warnings.