Pharmacovigilance and side effects

Dear Sir/ madam,

We are happy to answer any questions on adverse drug reactions (ADRs) in connection with the use of our products.

We will try to provide you with further information. If you report a suspected adverse reaction we would like to ask you to document your observations.

Report on a suspected adverse drug reaction (ADR)

Using this form, you can report a suspected adverse drug reaction (ADR) directly. We will reply as soon as possible.

The details will be transmitted to the following address:

medac GmbH
Pharmacovigilance
Theaterstrasse 6
22880 Wedel

e-mail-address: drugsafety@medac.de
Tel.: 04103 / 8006-777
Fax: 04103 / 8006-9130

Patient details

These data are needed to identify duplicate reports and to facilitate identification of the affected patient in case of questions.

Initials (first and last name)

Age *

Date of birth

SEX

female

male

Weight (kg)

Height (cm)

Study / observation study

no

yes

If study/observational study, please specify:

Underlying disease

Preparations (before occurrence of undesirable side-effects)

Product(s)/ substance(s) I *

Manufacturer and batch number I

Dose and unit I

Route of administration I

Therapy dates (from/until) I

Indication(s) I

Suspected causal relationship?

yes

no

Product(s)/ substance(s) II

Manufacturer and batch number II

Dose and unit II

Route of administration II

Therapy dates (from/until) II

Indication(s) II

Suspected causal relationship?

yes

no

Product(s)/ substance(s) III

Manufacturer and batch number III

Dose and unit III

Route of administration III

Therapy dates (from/until) III

Indication(s) III

Suspected causal relationship?

yes

no

Product(s)/ substance(s) IV

Manufacturer and batch number IV

Dose and unit IV

Route of administration IV

Therapy dates (from/until) IV

Indication(s) IV

Suspected causal relationship?

yes

no

If there is no suspicion of a causal relationship with the medac product, please specify the suspected cause (e.g. underlying disease, comorbidities)

Relevant history and comments

Contact details

Reported by

Physician

Pharmacist

Patient

Other

Your name *

Your address

Your telephone number

Your e-mail address *

Fields marked with an asterisk (*) are required.

Please consult our data protection policy.