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EMA Product

Rolufta Ellipta (previously Rolufta)

Product approved by European Medicines Agency (EU)

Basic Information

Rolufta Ellipta (previously Rolufta)

Regulatory Information

EMEA/H/C/004654

Authorised

March 20, 2017

January 26, 2017

14

March 28, 2025

Company Information

Ireland

12 Riverwalk Citywest Business Campus Dublin 24 D24 YK11

GLAXOSMITHKLINE TRADING SERVICES LIMITED

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Rolufta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Overview Summary

Rolufta Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Rolufta Ellipta is used for maintenance (regular) treatment. Rolufta Ellipta contains the active substance umeclidinium bromide.

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