DYMISTA® approved in children 6 to 11 years of age with seasonal allergic rhinitis

Meda announces the approval by FDA (U.S. Food and Drug Administration) of
Dymista, a single formulation azelastine hydrochloride and fluticasone
propionate nasal spray for the relief of symptoms of seasonal allergic rhinitis
in patients 6-11 years of age who require treatment with both components.
Dymista was previously indicated only for adults and children 12 and older. The
approved dosing for Dymista in children 6 to 11 is 1 spray/nostril BID (same as
the dosing for adolescents and adults with SAR).

The efficacy and safety of Dymista was demonstrated in 2 pediatric trials where
children 6 to 11 were treated with Dymista (1 spray per nostril twice daily).
One of these trials was a 2-week trial comparing efficacy of Dymista and placebo
in 304 children 6 to 11 years of age with SAR. The other trial was a 12-week
open-label trial comparing the safety of Dymista and fluticasone nasal spray in
353 children 6 to 11 years of age with allergic rhinitis.

According to William Berger, MD, practicing allergist, Allergy and Asthma
Associates of Southern California and Medical Director at Southern California
Research Center, Mission Viejo, California, “The approval of Dymista for
pediatric patients 6 to 11 years provides for a new, effective and safe
treatment option for those suffering from Seasonal Allergic Rhinitis. Patients
with SAR struggle to bring their symptoms under control; Dymista offers rapid
onset of symptom improvement within 30 minutes of administration and allows for
nasal symptom relief patients are seeking, all with a single nasal spray.”

The efficacy and safety of Dymista has been documented in several studies
involving over 4,000 patients, including long-term safety studies with more than
600 patients 12 years and older and in more than 350 patients aged 6 to 11
years.

For further inquiries, please contact:
Paula Treutiger, VP Corporate Communications & Sustainability
ph: +46 733-666 599

paula.treutiger@meda.se

MEDA AB (publ) is a leading international specialty pharma company. Meda’s
products are sold in more than 150 countries worldwide and the company is
represented by its own organizations in over 60 countries. The Meda share is
listed under Large Cap on Nasdaq Stockholm. Find out more, visit www.meda.se.