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Risk Minimization Materials – UK

Adverse events reporting information can be found at the bottom of this page.

The educational materials for patients or educational materials for healthcare professionals included here are additional risk minimization measures that are intended to promote the safe and effective use of the medicinal product. Risk minimization measures are a regulatory requirement and are approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

For questions regarding the medicine, please contact our medical information service: medinfoEU@bmrn.com.

Reporting and Contact Information

Besides downloading, you can also contact BioMarin at Medinfo@bmrn.com and ask for a BioMarin employee near you or request to have all materials sent to you.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Please report suspected adverse drug reactions (ADRs) to the MHRA through the Yellow Card Scheme. You can report via:

  • The Yellow Card website www.mhra.gov.uk/yellowcard
  • The free Yellow Card app available from the Apple App Store or Google Play Store
  • Some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank) for healthcare professionals

Alternatively you can report a suspected side effect to the Yellow Card scheme by calling 0800 731 6789 for free, Monday to Friday between 9am and 5pm. You can leave a message outside of these hours.

When reporting please provide as much information as possible. By reporting side effects, you can help provide more information on the safety of this medicine.

Adverse events should also be reported to BioMarin at +1 415 506 6179 or via email to: drugsafety@bmrn.com