Tag: European Commission

EC Approved Roche’s Tecentriq®

roche
Roche announced that the European Commission has approved Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® ) for the treatment of adult patients with unresectable locally advanced or metastatic ...

EU Granted Extension of the Indication for Novo Nordisk Fiasp®

Novo Nordisk
Novo Nordisk announced that the European Commission has granted an extension of the indication for Fiasp® (fast-acting insulin aspart), approving it for the treatment of diabetes in adolescents and ch...

IMQ Istituto Designated European Fourth Notified Body

European-Commission
The European Commission added Milan, Italy-based IMQ Istituto to its list of notified bodies designated under the new Medical Devices Regulation. The announcement does not come as a surprise, as It...

Germany-Based Dekra Certification Designated as Third Notified Body Under MDR

medical-devices
The European Commission announced that Germany-based Dekra Certification GmbH is the third notified body (NB) to be designated under the Medical Devices Regulation (MDR). Dekra joins Germany-based ...

EU Granted Marketing Authorisation for Novo Nordisk’s Esperoct

Novo Nordisk
Novo Nordisk announced that the European Commission has granted marketing authorisation for Esperoct®for the treatment of adolescents (≥12 years of age) and adults with haemophilia A. The authorisatio...

EC Approved Lynparza as 1st-Line Maintenance Treatment for BRCA-Mutated Ovarian Cancer

astrazeneca
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) announced that the European Commission (EC) has approved Lynparza (olaparib) as a 1st-line...

Baycox® Iron Injection Launched by Bayer in Europe

Bayer launches Baycox® Iron (36 mg/ml toltrazuril plus 182 mg/ml gleptoferron) suspension for injection for piglets across Europe following marketing authorization from the European Commission. Bay...

European Commission Approved Celgene Revlimid and Imnovid

Celgene Corporation announced that the European Commission (EC) has approved two new triplet regimens based on Celgene’s proprietary IMiD treatments, REVLIMID (lenalidomide) and IMNOVID (pomalidomide)...

EC Approved Indian Orphan Drug

The European Commission (EC) has approved NaMuscla (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders from Indian drugmaker Lupin. Non-dys...