Bayer’s Rivaroxaban submitted approval in Japan

Bayer’s Rivaroxaban submitted for approval in Japan

2:32 PM, 19th April 2011
Bayer’s Rivaroxaban submitted for approval in Japan

 

BERLIN, GERMANY: Bayer’s rivaroxaban (Xarelto) has been submitted for marketing approval in the prevention of stroke in patients with atrial fibrillation to the Japanese Ministry of Health, Labour and Welfare (MHLW).

The submission to the MHLW is based on the results of the global ROCKET AF study and the Phase III J-ROCKET AF study, which was run entirely in Japan. Results of the J-ROCKET AF study are planned to be presented at an upcoming major scientific meeting.

As communicated in January 2011, rivaroxaban 20 mg once daily has previously been submitted for marketing authorization in stroke prevention in patients with atrial fibrillation in the EU and the US. These submissions were supported by data from the pivotal, global Phase III ROCKET AF trial that was presented at the American Heart Association (AHA) Congress in November 2010.

(C) WOC News

 

0 Comments

Login

Your Comments (Up to 2000 characters)
Please respect our community and the integrity of its participants. WOC reserves the right to moderate and approve your comment.

Related News


Lonza and Organobalance sign licensing agreement

BASEL, SWITZERLAND/BERLIN, GERMANY: Lonza and Organobalance signed a global exclusive license agreement in which Lonza will develop, produce and comme ...

Read more
Evonik to sell carbon black business for excess of € 900 million

  The sale to Rhône Capital will open new growth prospects for carbon black business, informed the company. ESSEN, GERMANY: Evonik Indust ...

Read more
Lubrizol CEO expects to work ‘several more years’ under Buffett

  NEW YORK, US: Lubrizol Corp, the engine- additives maker selling itself to Warren Buffett’s Berkshire Hathaway Inc, said James Hamb ...

Read more
Aditya Birla acquires Swedish-Domsjö Fabriker for $ 340 million

  MUMBAI, INDIA: Aditya Birla Group announced it has acquired Domsjö Fabriker, a leading Swedish speciality pulp and bio-refinery company, ...

Read more
Aditya Birla acquires Swedish-based Domsjö Fabriker for $ 340 million

MUMBAI, INDIA: Aditya Birla Group announced it has acquired Domsjö Fabriker, a leading Swedish speciality pulp and bio-refinery company, throug ...

Read more
BP and Rosneft extend share swap deadline

  LONDON, UNITED KINGDOM: BP announced it has agreed with Rosneft to extend the deadline for completing the share swap agreement (previously ann ...

Read more
www.worldofchemicals.com uses cookies to ensure that we give you the best experience on our website. By using this site, you agree to our Privacy Policy and our Terms of Use. X