Attention: on 4th of July 2022 the Federal Agency for Medicines and
Health Products (FAMHP) launched
a new public medicines database. Consequently, the website notices.fagg-afmps.be you are
currently on will not be updated any further. For the most recent
version of all documents please visit the new public medicines
database.
Patient information leaflets (PIL) and summaries of product
characteristics (SPC) of medicinal products for human use
Each medicine has a patient information leaflet (which is in the
packaging of the medicine) and a summary of product characteristics or
SPC (designed specifically for healthcare professionals). Both
documents were approved at the time of the marketing authorization or
the registration of the medicine and constitute the information and the
reference for the appropriate and sure prescription, delivery and use
of the medicine.
This part of the site enables you to view and print the patient
information leaflet and the SPC of the medicines for human use approved
in Belgium, whether the medicines are under prescription or not.
The patient information leaflet and the SPC of medicines are made
available for information purposes only.
Always consult your doctor or pharmacist before taking any
medication.
The objective is to publish the patient information leaflet and the SPC
of all medicines for human use authorized in Belgium. The patient
information leaflet is available in French, Dutch and German. The SPC
in French and Dutch. Appendix V referred to in documents relating to
medicinal products authorized through the centralized procedure,
contains the details of the system for reporting adverse reactions in
each member state. Here attached the data of the Belgian
system.
However, it is always possible that the documents concerning some
authorized medicines are not available. The absence of a medicine in
the list on this site does not mean that it is not authorized or that
its use is not recommended. The database of
the authorised medicines allows you to check if the sought-for
medicine is authorized or registered. If you want to receive the
package leaflet or the SPC of an authorized medicine that is not in the
list published on this site, you can send an information request to: info.medicines@fagg-afmps.be
On the other hand the fact that the SPC and the patient
information leaflet of an authorized medicine indicated as marketed are
published on that page does not guarantee that it is currently
available or that all the presentations listed in these documents are
actually marketed in Belgium.
If the authorisation of a medicinal product is radiated, the
patient information leaflet and the SPC of this medicinal product go on
being published for a considerable time.
For the medicines that are subject to a parallel import
authorisation, please see the patient information leaflet and the SPC
of the reference product. Medicines that are subject to a parallel
import authorisation are identified by the letters "IP" in the
authorisation number and the words "imported by ... " mentioned on
their packaging. This information also appears on the patient
information leaflet of these medicines.
The publication of the patient information leaflets and the SPC
is regularly updated. However there might be a delay between the
authorisation date of a new medicine and the date of the publication of
the patient information leaflet and the SPC on this site. The patient
information leaflets and the SPC may also be subject to changes. You
find on this site the latest version of the patient information
leaflets and the SPC of the authorized medicines. However, a waiting
time is possible between the date of the approval of a modification of
the patient information leaflet and/or the SPC of an existing medicine
and the date of publication on this site of the amended documents.
However if the changes concern essential data for the safe and
effective use of a medicine, the documents will be updated as soon as
possible. These changes, sometimes successive, also mean that the
leaflet enclosed in the packaging of a medicine manufactured before the
date of implementation of these changes may be different from that
published on this site.
How to search?
1. Enter the name or at least the first 3 letters of the name of
the sought-for medicine in the ad hoc adjoining field and click on the
magnifier.
2. You get an overview of the data sheet(s) of the medicine or the
medicines that match the query, together with the pictograms
corresponding to the public leaflet in the three national languages and
the SPC in French and Dutch.
If there are no documents available
in the column SPC, the SPC and leaflet are identical. You can then find
the SPC via the pictogram “leaflet”.
3. Click on the pictogram of the document you want to consult:
you can open or save the file and then print it if you wish.
4. To start a new query, click on "Reset" (x)
and start again from step 1.
Disclaimer
Despite all the care given to this publication of the patient
information leaflets and the SPC of the authorized medicines in
Belgium, the FAMHP cannot guarantee the completeness and the conformity
of these documents with the approved data at the time of the marketing
authorization or registration.
Don't hesitate to send your remarks or comments to info.medicines@fagg-afmps.be.
The FAMHP declines all liability for any direct or indirect
damage resulting from the use of this database. The FAMHP also reminds
readers that this information in no way replaces the necessary advice
of your doctor or pharmacist for any use of a medicine. The FAMHP gives
no guarantee that the information included in this database does not
violate the right of the intellectual property.