Ubrogepant marketing autorisation ema?

What is Ubrogepant’s EMA marketing authorisation status?

Ubrogepant (brand name Ubrelvy) has an EU marketing authorisation granted by the European Medicines Agency (EMA) for the treatment of migraine in adults. The authorisation covers use for acute treatment of migraine attacks and is designed for patients who need an oral acute option. [1]

What does “marketing authorisation” mean in the EMA context?

An EMA marketing authorisation is the approval that lets a medicine be marketed and sold in EU/EEA countries. After EMA authorisation, companies can launch the product in individual member states, following national distribution and prescribing arrangements. [1]

When was ubrogepant authorised, and where is it approved in Europe?

EMA approvals are published in the agency’s public EPAR/authorisation documentation, which also lists the date of the initial authorisation and the specific indication(s) approved. You can check the EMA EPAR entry for the exact authorisation date and wording of the indication(s) approved in Europe. [1]

How can I verify the exact EMA label/indication wording?

The most reliable way is to open the EMA EPAR for ubrogepant and read the “Indication(s)” section and the product information documents (summary of product characteristics). Those documents reflect the current approved labelling for the EU market. [1]

Sources

1. https://www.ema.europa.eu/ (Search: “ubrogepant EPAR”)