You have reached the TranslarnaTM (ataluren) website developed by
PTC Therapeutics to provide you with information about this medicine

Please click on the link appropriate for you:

The list below contains links to the Medicines & Healthcare products Regulatory Agency for the UK excluding Northern Ireland and to the European Medicines Agency for Northern Ireland and the Republic of Ireland. Through these websites, you will find links to the European Public Assessment Report (EPAR) as well as the Patient Information Leaflets (PIL) and Summary of Product Characteristics (SPC) for Translarna (ataluren).

Please note that this information is not intended to replace the advice of a qualified healthcare professional.

Translarna (ataluren) SmPC PIL for the UK excluding Northern Ireland:
https://products.mhra.gov.uk/search/?search=ataluren&page=1
Translarna (ataluren) SmPC PIL for Northern Ireland and the Republic of Ireland:
https://www.ema.europa.eu/en/medicines/human/EPAR/translarna

For Medical Information please contact us as follows: medinfo@ptcbio.com Tel: 0345 075 4864 in the UK including Northern Ireland and 01447 5165 in the Republic of Ireland

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects.

UK: Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk. Adverse events should also be reported to PTC on 0345 075 4864 or pharmacovigilance@ptcbio.com.

Ireland: Adverse events should be reported to the Pharmacovigilance Unit at the Health Products Regulatory Authority (HPRA) at: www.hpra.ie. Adverse events should also be reported to PTC on 01447 5165 or pharmacovigilance@ptcbio.com.

Conditional marketing authorisation granted in the European Economic Area is subject to annual reassessment and renewal by the EMA and the European Commission. The information contained within is intended for healthcare professionals only.

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