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Fachinformation

Fachinformation is the professional information document that accompanies a medicinal product and is intended primarily for healthcare professionals. It contains legally required, scientifically validated data about a medicine to support safe and effective use. The document is written in technical language and differs from patient-oriented information (Patienteninformation), which targets laypeople.

Typical content includes indications and dosage, contraindications, warnings and precautions, interactions with other medicines, use in

In the European Union and Germany, the Fachinformation forms part of the marketing authorization and is updated

Access to up-to-date Fachinformation is usually provided via regulatory databases and the manufacturer, and may also

special
populations
(pregnancy,
lactation,
children,
elderly),
adverse
reactions,
pharmacology
and
pharmacokinetics,
and
practical
details
such
as
storage,
excipients,
and
packaging.
It
is
designed
to
provide
a
comprehensive
reference
for
prescribers
and
pharmacists
to
support
clinical
decision-making
and
safe
handling
of
the
product.
by
the
sponsor
in
coordination
with
national
authorities.
It
is
aligned
with
the
Zusammenfassung
der
Merkmale
des
Arzneimittels
(SmPC)
and
serves
as
the
primary
technical
reference
for
professionals.
The
document
is
typically
maintained
by
the
manufacturer
and
regulatory
authorities
ensure
that
the
latest
version
is
accessible
to
medical
staff.
appear
in
the
printed
packaging
materials.
It
complements
the
patient-focused
information
and
forms
part
of
the
official
framework
that
governs
the
safe
use
of
medicines
in
clinical
practice.