Pharmacovigilance

Dear Sir or Madam,

if you have any questions concerning Adverse Drug Reactions (ADR) of our products please ask us at any time.

We will try to help you and provide you with further information. If you report about an ADR-case we will furthermore ask you for documentation of the case.

Contact Pharmacovigilance Department

EU-Qualified Person for Pharmacovigilance

medac GmbH
Referat Arzneimittelsicherheit
Theaterstrasse 6
22880 Wedel

E-Mail: drugsafety@medac.de
Phone: +49 (0)4103 8006-777
Fax: +49 (0)4103 8006-9130

Which ADR reports are important?

In general we are interested in all reports of adverse drug reactions of our drugs, independent if expected, unexpected, serious, frequent or rare. Special attention is paid to serious and unexpected cases.

A continuous surveillance of the benefit and risk of our drugs is only possible by the help of all concerned persons.

How to report an ADR?

It would be very helpful for us if you could report your case on the ADR-form in order to achieve a standardized recording.

We will mail the ADR-form on request to you. If it is more convenient for you, please use this online form:

Please send the filled-in form to us and add if necessary further information, e.g. pseudonymous doctor`s letter.

What will medac do with your report?

Your report will be assessed by a physician or pharmacist of medac and concerning patient`s name pseudonymously registered in our data base. Normally you receive a confirmation letter from us and - if requested - further information.

Urgent questions concerning pharmacovigilance out of working hours

Out of working hours you can reach us for urgent questions concerning pharmacovigilance. In this case please contact medac by phone +49-41038006-0. You will be informed about the phone numbers to reach us.

In case of acute symptoms please call an ambulance.

Abbreviations, specific terms

ADR = adverse drug reaction

Adverse reaction = A response to a medicinal product which is noxious and unintended.

Serious drug adverse reaction = An adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.

Unexpected drug reaction = An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.

If you are interested you are allowed to copy and hand out this text provided that you mention the source (Pharmacovigilance Department, medac GmbH).