LONDON, April 24, 2008-On 24 April 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,** recommending to grant a marketing authorisation for the medicinal product Janumet, 50 mg/850 mg and 50mg/1000 mg film-coated tablet intended for treatment of type 2 diabetes mellitus. The applicant for this medicinal product is Merck Sharp & Dohme Ltd.
On 24 April 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,** recommending to grant a marketing authorisation for the medicinal product Latixa, 375 mg, 500 mg and 750 mg prolonged-release tablets intended for treatment of patients with stable angina pectoris. The applicant for this medicinal product is CV Therapeutics Europe Limited.
On 24 April 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a conditional marketing authorisation for the medicinal product Tyverb, 250 mg, film-coated tablet, intended for treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2) and who have received prior therapy including anthracyclines, taxanes and trastuzumab. The applicant for this medicinal product is Glaxo Group Limited.
April 24, 2008 -- Wyeth Pharmaceuticals, a division of Wyeth , and Progenics Pharmaceuticals, Inc. , today announced that the companies have received a positive opinion for Relistor (methylnaltrexone bromide) subcutaneous injection from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA). The companies are seeking the approval of Relistor in Europe for the treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
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