european approval articles & resources on Made-in-China.com

Sorin Group Recently Announced CE Mark Approval of Its Solo Smart Stentless Aortic Valve

Nov 26, 2013

The Sorin Group recently announced CE Mark approval of its Solo Smart stentless aortic valve, which Milan, Italy-based Sorin is touting as an improvement on its Freedom Solo valve that has been used in Europe since 2004. So how did Sorin ...

Tags: Sorin Group, Solo Smart Valve

Pfizer Has Secured European Commission Approval to Carry out Updates

Oct 21, 2013

Pfizer has secured European Commission approval to carry out updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in certain high-risk populations. Now the ...

Tags: Pfizer, Label Update

Eisai Has Secured Approval From The European Commission on License Extension Application

Oct 8, 2013

Japanese pharmaceutical firm Eisai has secured approval from the European Commission (EC) on the license extension application for the use of antiepileptic agent Zonegran (zonisamide) in the treatment of pediatric patients. The EC ...

Tags: Eisai Obtains, Zonegran

EMA Has Received an Application From Bayer HealthCare for Marketing Authorization

Sep 10, 2013

The European Medicines Agency (EMA) has received an application from Bayer HealthCare for marketing authorization of its oral multi-kinase inhibitor, regorafenib, for the treatment of patients with gastrointestinal stromal tumors (GlST). ...

Tags: Bayer, Medicine

Pfizer Has Obtained European Approval for The Expanded Use of Prevenar 13

Jul 12, 2013

Pfizer has obtained European approval for the expanded use of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), in adults between 18 to 49 years of age for the prevention of invasive pneumococcal disease. ...

Tags: Pneumococcal Vaccine, Medicine

Aptushas Received CE Mark Approval for Endosystems Thoracic-Length Heli-Fx System in EU

Apr 4, 2013

Aptus Endosystems has received CE mark approval from the European Union for its thoracic-length Heli-FX system for thoracic aortic aneurysms (TAA) treatment. Featuring a longer delivery device with additional tip configurations, the ...

Tags: Heli-FX System, Medicine, Medical Device

The European Commission Has Approved ThromboGenics' Jetrea for The Treatment of VMT

Mar 19, 2013

The European Commission has approved ThromboGenics' Jetrea (ocriplasmin) for the treatment of vitreomacular traction (VMT), including when coupled with macular hole of diameter less than or equal to 400 microns, in the European Union (EU). ...

Tags: ThromboGenics Jetrea, vitreomacular traction treatment, drug

The US FDA Has Approved Novartis Zortress as The First Drug to Prevent Organ Rejection

Feb 19, 2013

The USFDA has approved Novartis Zortress as the first drug to prevent organ rejection in adult patients receiving liver transplantation in the US. The approval was based on positive data from liver transplant study that compared Zortress ...

Tags: medication, FDA, Zortress

CE Mark Is Received by St Jude Medical for Portico Transcatheter Aortic Heart Valve

Dec 18, 2012

St Jude Medical has received CE mark approval for its Portico Transcatheter aortic heart valve which is designed to treat patients with severe aortic stenosis who are at intermediate risk for undergoing open-heart surgery. The 23 mm ...

Tags: CE mark, aortic heart valve, medical device, Medical equipment

The EMA Committee Recommended The Approval of Amag Pharmaceuticals' Ferumoxytol

Nov 28, 2012

The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AMAG Pharmaceuticals' ferumoxytol, an iron deficiency anemia (IDA) therapy. The intravenous (IV) iron therapy, indicated for the treatment of ...

Tags: AMAG Pharmaceuticals, iron deficiency anemia(IDA)therapy

European Commission Has Approved Vertex Pharmaceuticals's Kalydeco

Jul 30, 2012

The European Commission has approved Vertex Pharmaceuticals' Kalydeco (ivacaftor) to treat the underlying cause of cystic fibrosis in people with a specific genetic mutation (G551D). The approval is based on positive findings from two ...

Tags: european approval, kalydeco, cystic fibrosis

european approval

Related Products