Organon's Once-a-Month Contraceptive Ring, NuvaRing(R) Completes European Authorization
Oss, The Netherlands (ots/PRNewswire) - Organon announced today that NuvaRing(R) (etonogestrel/ethinyl estradiol vaginal ring), the company's once-a-month contraceptive, has successfully completed the European Mutual Recognition Procedure (MRP) in an additional 13 countries (1).
NuvaRing is already approved in 14 European Union territories using the Mutual Recognition Procedure with the Netherlands as the Reference Member State. National marketing authorizations for the latest countries - including the UK, Poland and Czech Republic - have been applied for, and will extend NuvaRing's availability throughout the EEA (EU countries and Iceland and Norway) to over 40 countries globally.
NuvaRing was developed to increase the convenience of contraceptive use. It is a flexible ring that is inserted into the vagina by a woman herself and remains there for 21 days. It combines protection against pregnancy with a low incidence of side effects. Compared to commonly used combined oral contraceptives, in addition to its once-a-month contraceptive regimen, NuvaRing reduces women's estrogen exposure, providing 15 mcg of ethinyl estradiol and 120 mcg etonogestrel daily.
"We are delighted to be able to extend the availability of NuvaRing throughout Europe," said Emile van Dongen, executive vice president Global Sales at Organon. "Its uptake is increasing in all European countries where it is already available and even more in the US. There is an exciting momentum growing around this product, used by more than 1.5 million women."
Since its introduction in 2002, sales of the once-a-month ring have grown strongly year-on-year - from slightly more than EUR 6 million in 2002 to EUR 216 million at the close of 2006 - as awareness has gradually increased among women and the medical fraternity. Currently used by over 1.5 million women worldwide, the uptake of NuvaRing(R) is continuing to grow by at least 25 percent in all major markets. Latest figures even show a 42 percent increase in sales in the U.S. market.
(1) A national marketing authorization for NuvaRing was granted in the Netherlands on February 14, 2001. A mutual recognition procedure was subsequently completed on June 12, 2001 with the Netherlands acting as Reference Member State. A repeat use/second wave mutual recognition procedure was undertaken in 2003 leading to NuvaRing's approval and subsequent introduction in France. This latest repeat use mutual recognition procedure was approved in and applies to Bulgaria, Cyprus, Czech Republic, Malta, Poland, Romania, Slovenia, the UK, Estonia, Hungary, Latvia, Lithuania, and Slovak Republic.
Organon creates, manufactures and markets innovative prescription Medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.
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ots Originaltext: N.V. Organon
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