FAQs

Adverse event reporting and additional monitoring

Safety Data Sheets can be accessed on the Roche global website.

For information on the safe handling of Roche products please consult section 6.6, Special precautions for disposal and other handling, of the Summary of Product Characteristics (SPC), which are available via the following links: Great Britain (England, Scotland, Wales): https://www.medicines.org.uk/emc. Northern Ireland https://www.emcmedicines.com/en-GB/northernireland/

Information is also available in the Safety Data Sheets, which can be accessed on the Roche website

If you have any further questions, please contact Roche Medical Information on Freephone 0800 328 1629 or medinfo.uk@roche.com.

For the Summary of Product Characteristics for all Roche products available in Great Britain (England, Scotland, Wales) visit:
https://www.medicines.org.uk/emc. For Northern Ireland visit: https://www.emcmedicines.com/en-GB/northernireland/

For Roche Products that have a European licence, copies of the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) are available in other European languages on the European Medicines Agency (EMA) website.

Please then search for and select the product you are interested in. To access copies of the SPC and PIL in European languages, select the “Product information” tab. “EPAR - Product Information” can then be viewed in a variety of languages using the dropdown menu. Annex I of this document contains the SPC, whilst Annex IIIB contains the PIL.

Roche recommend that our products are stored as described in their respective Summary of Product Characteristics (SPC) which are available via the following links Great Britain (England, Scotland, Wales): https://www.medicines.org.uk/emc. For Northern Ireland visit: https://www.emcmedicines.com/en-GB/northernireland/

Roche UK do not provide general stability data for our products. In the event of a temperature excursion we assess the likely impact of the temperature excursion on a case-by-case basis. This is to ensure that the information we provide is as accurate and useful as possible to help you make an informed decision about whether or not the product is suitable for use and in the interest of patient safety.

The stability data held by Roche is dependent on batch. It is also important to consider the storage of a product throughout the supply chain when assessing the likely impact of a temperature excursion on its quality. It is therefore necessary for us to assess temperature excursions on a case-by-case basis rather than providing general stability data which, when used in isolation, would not allow for an accurate assessment to be made.

Following a temperature excursion, please print and complete a copy of the Temperature Excursion form which can be requested from the Roche Medical Information team. A signed copy of this form should then be scanned and emailed to medinfo.uk@roche.com.

Please note that for some temperature excursions, it may take 5 to 10 business days for us to make a full assessment: We will let you know if this is necessary.

Please also be aware that Roche are unable to assess the stability of products which have been stored outside of their licensed storage conditions for more than 28 days, and these products should not be used.

If you require any further information about this process, please contact Roche Medical Information on Freephone 0800 328 1629 or medinfo.uk@roche.com for further information.

For information regarding clinical trials, please see; clinicaltrials.gov or www.ukctg.nihr.ac.uk.

Roche is committed to data sharing, as we know the value that clinical data can have in making informed decisions. We are also aware of the impact that data sharing can have within the scientific community and the broader public.

If you are a qualified healthcare professional or researcher, and would like to request access to clinical study documents, please see the Roche global website for further information.

Downloadable patient materials may be accessed here. For the availability of other materials please contact Roche Medical Information on Freephone 0800 328 1629 or medinfo.uk@roche.com.

Medicinal products that display the black triangle symbol ▼ are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 36 7554. For medicines which are biological, healthcare professionals should report adverse reactions by brand name and batch number.