We are an international biopharmaceutical company dedicated to meeting the real medical needs of patients with serious diseases. We invest billions in Research and Development (R&D), including the discovery and development of new medications.
Below is a list of products marketed by our company. All linked documents and websites are intended for residents 18 years or older only, as the availability of medicines and the indications for which they are approved may vary by country and region.
Please refer to the full prescribing information approved by the relevant government authorities in your country of residence and consult your physician for professional medical advice and services.
If you suspect an adverse reaction, we recommend that you contact your treating physician.
We would appreciate it if you would also report possible side effects of our products to us. Reporting them allows us to monitor and promote the safety and effectiveness of our medicines. Your reports will also be shared with the relevant government authorities. You can submit your reports by using the following e-mail address: firstname.lastname@example.org
You can also report side effects to the Nederlands Bijwerkingen Centrum Lareb. The Lareb is the national contact point for adverse drug reactions in the Netherlands. By collecting all reports at one central point, Lareb is able to monitor the safety of medicines in the Netherlands. It is therefore important that as many side effects as possible are actually reported!
To do this, you can consult the following website: www.meldpuntbijwerkingen.nl.
If you have a complaint about any of our products (this can be about the quality, efficacy, authenticity or satisfaction of a medicine), we would like to hear from you at email@example.com
Black triangle - drugs under additional monitoring
The European Union (EU) has introduced a new procedure for the product information of medicines that supervisory authorities are monitoring extra closely. The package insert for these medicines states that they are subject to 'additional monitoring'.
The package insert and the product information for medical professionals, the so-called "summary of product characteristics", of medicines subject to this additional monitoring contain a black inverted equilateral triangle with a short sentence indicating what the triangle means: this medicine is subject to additional monitoring.
The black triangle will be used in all EU member states to identify medicines under this additional surveillance. The symbol will appear on the relevant package leaflets from autumn 2013. It will not appear on the outer packaging or label of medicines.
Patients and medical professionals are strongly advised to report all suspected adverse drug reactions with a black triangle so that new information that becomes available can be analyzed in a targeted manner.
For more information on the black triangle, please refer to the website of the Medicines Evaluation Board (CBG): www.cbg-meb.nl.
ORENCIA 250 mg powder for concentrate for solution for infusion (abatacept)
ORENCIA 125 mg solution for injection in a prefilled syringe (abatacept)
ORENCIA 125 mg solution for injection in a prefilled pen (abatacept)
KENACORT A-10 (triamcinolonacetonide)
KENACORT A-40 (triamcinolonacetonide)