Dymista filed in Europe


Dymista filed in Europe

The marketing authorization application for Dymista (a novel formulation
of azelastine hydrochloride and fluticasone propionate) has been filed
in Europe. The application uses a decentralized procedure and the
reference member state is Germany.

Dymista is a nasal spray formulation for patients with symptomatic
treatment of moderate to severe allergic rhinitis and
rhinoconjuctivitis. The efficacy and safety of Dymista has been
documented in several studies involving over 4,000 patients, including a
long-term safety study with more than 600 patients.

"The regulatory filing for Dymista in Europe is important for our
azelastine franchise. Earlier this year, Dymista was filed in the US and
we will continue now with filings in other key markets", said Anders
Lönner, CEO of Meda AB.

The marketing authorization application for Dymista (a novel formulation
of azelastine hydrochloride and fluticasone propionate) has been filed
in Europe. The application uses a decentralized procedure and the
reference member state is Germany.

Dymista is a nasal spray formulation for patients with symptomatic
treatment of moderate to severe allergic rhinitis and
rhinoconjuctivitis. The efficacy and safety of Dymista has been
documented in several studies involving over 4,000 patients, including a
long-term safety study with more than 600 patients.

"The regulatory filing for Dymista in Europe is important for our
azelastine franchise. Earlier this year, Dymista was filed in the US and
we will continue now with filings in other key markets", said Anders
Lönner, CEO of Meda AB.

For further inquiries, please contact:

Anders Larnholt, Vice President Corporate Development & IR ph: 46
709-458 878

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