UCB COMPLETES MUTUAL RECOGNITION PROCEDURE FOR EQUASYM XL.UCB, Brussels, Belgium, has successfully completed the European Mutual Recognition Procedure (MRP) for Equasym(TM) XL for use in the treatment of the symptoms of attention deficit hyperactivity disorder attention deficit hyperactivity disorder (ADHD), formerly called hyperkinesis or minimal brain dysfunction, a chronic, neurologically based syndrome characterized by any or all of three types of behavior: hyperactivity, distractibility, and impulsivity. (ADHD Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or ) with the UK acting as the Reference Member State for the MRP. All concerned member states endorsed the summary of product characteristics. The national marketing authorizations are expected to be issued over the coming months. Equasym(TM) XL was launched in the UK, the first European market in 2005. Troy Cox, president CNS See Continuous net settlement. CNS See continuous net settlement (CNS). Operations, UCB said, "On the granting of national licences we look forward to making Equasym(TM) XL available as a valuable ADHD treatment option to patients, families and physicians in 12 more European countries. At UCB, we are committed to minimizing the impact of ADHD on children during their formative years." ADHD is a common neurobehavioural disorder that affects approximately three to seven percent of school-aged children[1]. The three main symptoms of ADHD are inattention, hyperactivity and impulsivity. Children with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem. About Equasym(TM) XL Equasym(TM)XL 10, 20 and 30 mg capsules is indicated as part of a comprehensive treatment program for attention-deficit/hyperactivity disorder in children over six years of age when remedial measures alone prove insufficient. Equasym(TM) XL is designed to deliver therapeutic plasma levels for a period of approximately eight hours which is consistent with the school day rather than the whole day. Equasym(TM)XL is contra-indicated in patients known to be hypersensitive to methylphenidate or to any of the excipients excipients, n.pl all the constituents of a remedy that lack medicinal properties. See also adjuvant, auxiliary substance, and vehicle. ; in patients with marked anxiety, agitation or tension as the use of Equasym(TM) XL may aggravate these symptoms; in patients with glaucoma; in patients with hyperthyroidism hyperthyroidism: see thyroid gland. ; in patients with thyrotoxicosis thyrotoxicosis /thy·ro·tox·i·co·sis/ (thi?ro-tok?si-ko´sis) a morbid condition due to overactivity of the thyroid gland; see Graves' disease. thy·ro·tox·i·co·sis n. ; in patients with severe angina pectoris; in patients with cardiac arrhythmia; in patients with severe hypertension; in patients with heart failure; in patients with myocardial infarction; in patients who currently exhibit severe depression, psychotic symptoms, psychopathological personality structure, history of aggression or suicidal tendency, since methylphenidate might worsen these conditions; in patients with known drug dependence or alcoholism; in combination with non-selective, irreversible monoamine monoamine /mono·amine/ (mon?o-ah-men´) an amine containing one amino group, e.g., serotonin, dopamine, epinephrine, and norepinephrine. mon·o·am·ine n. oxydase inhibitors, and also within a minimum of 14 days following discontinuation of a non-selective irreversible MAO inhibitor; in patients with motor tics, tics in siblings, or a family history or diagnosis of Tourette's syndrome and during pregnancy. The most commonly reported adverse events in pivotal studies are insomnia and nervousness. Other commonly reported adverse events include arrhythmia, palpitations, tachycardia, abdominal pain, nausea, vomiting, dry mouth, decreased appetite, reduced weight gain during prolonged use, arthralgia, changes in blood pressure and heart rate, dizziness, drowsiness, dyskinesia dyskinesia /dys·ki·ne·sia/ (-ki-ne´zhah) distortion or impairment of voluntary movement, as in tic or spasm.dyskinet´ic biliary dyskinesia , headache, hyperactivity, abnormal behaviour, aggression, agitation, anorexia, anxiety, depression, irritability, alopecia, pruritus pruritus /pru·ri·tus/ (proo-ri´tus) itching.prurit´ic pruritus a´ni intense chronic itching in the anal region. pruritus hiema´lis xerotic eczema. , rash, and urticaria. This product is marketed in the US under the brand name Metadate(TM) CD and has received marketing approval in Finland. About UCB UCB is a global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency , allergy/respiratory diseases, immune and inflammatory disorders and oncology - UCB focuses on securing a leading position in severe disease categories. Employing over 8,500 people in over 40 countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is listed on the Euronext Brussels Exchange with a market capitalization of approximately 6.0 billion euro. Worldwide headquarters are located in Brussels, Belgium. References [1] National Institutes of Health Consensus Development Conference Statement: Diagnosis and treatment of attention-deficit hyperactivity disorder Attention-deficit hyperactivity disorder (ADHD) A condition in which a person (usually a child) has an unusually high activity level and a short attention span. People with the disorder may act impulsively and may have learning and behavioral problems. (ADHD). J Am Acad Child Adolesc Psychiatry 2000: 39: 182-93 For more information, visit http://www.ucb-group.com |
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