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GlaxoSmithKline (GSK) and Theravance have obtained approval from the Japanese Ministry of Health, Labour and Welfare for Anoro Ellipta to treat chronic obstructive pulmonary disease (COPD).
The Japanese approval for Anoro Ellipta is for the relief of various symptoms due to airway obstruction with COPDs, in the case where concurrent use of long-acting inhaled muscarinic antagonist and long-acting inhaled beta2 agonist is required
GSK and Theravance announce Japanese approval for Anoro Ellipta
GlaxoSmithKline (GSK) and Theravance have obtained approval from the Japanese Ministry of Health, Labour and Welfare for Anoro Ellipta to treat chronic obstructive pulmonary disease (COPD).
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing authorisation of Teva Pharmaceutical’s Seasonique for prevention of pregnancy.
Seasonique (levonorgestrel (0.15mg)/ethinyl estradiol (0.03mg) and low-dose ethinyl estradiol (0.01mg) tablets) is a 91-day extended-regimen oral contraceptive that contains a combination of female hormones that prevent ovulation.
The CHMP concluded that the benefits of Seasonique outweigh its risks and that marketing authorisation should be granted in France and in the EU member states of Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and Slovenia.
CHMP recommends Teva’s pregnancy prevention drug
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing authorisation of Teva Pharmaceutical’s Seasonique for prevention of pregnancy.
CHMP recommends Teva’s pregnancy prevention drughttp://www.pharmaceutical-technology.com/news/newschmp-recommends-tevaspregnancy-prevention-drug-4310517