Dear Healthcare Professional Letter on the important information on stickers on vials as precaution measure for safe use of Erivedge 150 mg hard capsules (vismodegib)
03.12.2014
Roche d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines agency (EMA) has sent a letter to healthcare professionals on the important information on stickers on vials as a precaution measure for safe use of Erivedge 150 mg hard capsules (vismodegib).
Summary
- There is a multilayer sticker containing information on the product use indicated also in the product information
- In very rare cases the following errors have been detected on the backside of this multilayer sticker:
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- the information is cut and first letters are missing.
- the glue is too strong and may decrease readability.
- The most important information indicated on the front side of the sticker is not encompassed.
- Roche is currently seeking for solutions to resolve discovered errors in the future.
- As a precaution measure, healthcare professionals should remind patients to the following:
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- When under Erivedge treatment, patients should always keep the package leaflet that is attached to the vial.
- In the case that the information on the backside of the multilayer sticker is not completely readable, patients should read the package leaflet.
Additional information
Described errors are discovered in very rare cases. The most important information indicated on the front page of the sticker is not encompassed, whereas the information on the backside of the sticker is indicated in the product information. Therefore the risk of the discovered error on the sticker is estimated minimal for the patient’s safety. The letter is addressed as a precaution measure aimed at informing healthcare professionals to ensure the safe use of the medicine.
Here you may view the Dear Healthcare Professional Letter.
This Dear Healthcare Professional Letter is sent with the other letter, informing healthcare professionals on teratogenic effects of the medicine and the Pregnancy prevention programme with the attached adequate education material and authorised by HALMED. Here you may read about the other Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
