EC – media

Shingrix approved in Europe and Japan for the prevention of shingles in adults aged 50 and over

The only shingles vaccine to achieve ≥90% efficacy across all age groups studied
- Source: gsk
- 630
- May 7, 2018
EC GSK post-herpetic neuralgia Shingrix
TiGenix and Takeda announce Alofisel® (darvadstrocel) receives approval to treat complex perianal fistulas in Crohn’s disease in Europe

First allogeneic stem cell therapy to receive central marketing authorization approval in Europe. Alofisel offers a new treatment option for patients who do not respond to current available therapies and may be subject to numerous invasive surgeries1
- Source: tigenix
- 612
- March 27, 2018
Alofisel EC New Approvals perianal fistulas Takeda
GSK announces positive EU approval for labelling update to Relvar Ellipta in patients with asthma

GlaxoSmithKline plc (LSE/NYSE:GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the European Commission has approved a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS) / long-acting β2-agonist (LABA) combination, in patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting β2-agonist.
- Source: us.gsk
- 917
- March 12, 2018
asthma EC GSK Relvar Ellipta
Joining ICH–Opportunity or Challenge?

Ddu has gradually made its way through Europe by attending the CPhI Worldwide 2017 in Frankfurt and Medica 2017 in Düsseldorf, Germany. During conversations with manufacturers, ICH was frequently mentioned. Since China was admitted as one of the regulatory members of ICH in June of last year, it was now placed at the forefront of the discussions.
- Source: drugdu
- 741
- November 2, 2017
Ddu College EC FDA ICH MHLW PMDA
Shire Receives European Approval for Label Extension of FIRAZYR® (icatibant injection) for the Symptomatic Treatment of Acute HAE Attacks in Paediatric Patients

Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in serving patients with rare diseases, announced today that the European Commission (EC) has approved a label extension granting a new indication for FIRAZYR® (icatibant injection), broadening its use to adolescents and children aged 2 years and older, with hereditary angioedema (HAE) caused by C1-esterase-inhibitor (C1-INH) deficiency. FIRAZYR has been approved in the European Union (EU) since 2008 for symptomatic treatment of acute attacks of HAE in adults with C1-INH deficiency.
- Source: finance.yahoo
- 547
- October 30, 2017
EC FIRAZYR® HAE Shire

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