EMA — authorised 31 December 2009
- Application: EMEA/H/C/001069
- Marketing authorisation holder: Glaxo Group Limited
- Local brand name: Bosatria
- Pathway: orphan
- Status: withdrawn
🇪🇺 Nucala in European Union
EMA authorised Nucala on 31 December 2009
Marketing authorisations
EMA — authorised 1 December 2015
- Application: EMEA/H/C/003860
- Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
- Local brand name: Nucala
- Indication: Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older . Chronic rhinosinusitis with nasal polyps (CRSwNP)Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. Eosinophilic granulomatosis with polyangiitis (EGPA)Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting
- Status: approved
Nucala in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in European Union
Frequently asked questions
Is Nucala approved in European Union?
Yes. EMA authorised it on 31 December 2009; EMA authorised it on 1 December 2015.
Who is the marketing authorisation holder for Nucala in European Union?
Glaxo Group Limited holds the EU marketing authorisation.