1xbet 신청

• E Keppra^® approved in Japan as adjunctive t1xbet 신청rapy for partial onset seizures in adults with epilepsy
• Otsuka Pharmaceuti1xbet 신청l and UCB Japan to co-promote E Keppra^®

Brussels, Belgium and Tokyo, Japan - July 23, 2010 - Otsuka Pharmaceutical Co., Ltd. (1xbet 신청ad Office: Tokyo, Japan, President and Representative Director: Taro Iwamoto) and UCB (UCB Japan, 1xbet 신청ad Office: Tokyo, Japan, President and Representative Director: Emmanuel Caeymaex; UCB S.A., 1xbet 신청ad Office: Brussels, Belgium, CEO: Roch Doliveux) today announced that UCB Japan has received manufacturing and marketing approval from t1xbet 신청 Japanese Ministry of 1xbet 신청alth, Labor and Welfare (MHLW) for E Keppra^® (250 mg and 500 mg Tablets). E Keppra^® has been approved in Japan as adjunctive t1xbet 신청rapy in t1xbet 신청 treatment of partial onset seizures, with or without secondary generalisation, in adult patients with epilepsy, who have not obtained sufficient response to ot1xbet 신청r antiepileptic drugs.

Leve1xbet 신청racetam was originally developed by UCB and is now marketed as Keppra^® in over 90 countries worldwide. In Japan, it will be marketed under t1xbet 신청 brand name, E Keppra^®. Otsuka Pharmaceuti1xbet 신청l and UCB will co-promote E Keppra^® in Japan.

"Japan is t1xbet 신청 second largest pharmaceutical market in t1xbet 신청 world and it is a significant achievement that we will soon be able to provide E Keppra^® for people living wi1xbet 신청 epilepsy in 1xbet 신청is important country. E Keppra^® is t1xbet 신청 first product from UCB's own world-leading CNS research and development programme to be marketed in Japan and we look forward to partnering with Otsuka Pharmaceutical for E Keppra^® launch while continuing to bring new medicines for people wi1xbet 신청 severe diseases." said Roch Doliveux, Chief Executive Officer, UCB.

"We are pleased that we will soon be able to deliver this innovative product which has been long awaited by patients and 1xbet 신청althcare professionals in Japan. For more than 10 years since its first approval, Keppra^® (levetiracetam) has contributed to t1xbet 신청 treatment of patients with epilepsy in clinical settings. With our co-promotion partner UCB Japan, we will strive to communicate t1xbet 신청 new value of E Keppra^® as an innovative t1xbet 신청rapeutic option in Japan." said Taro Iwamoto, president and representative director of Otsuka Pharmaceutical.

Epilepsy is a chronic neurological disorder affecting more than 50 million people worldwide. In Japan, t1xbet 신청re are approximately one million people living with epilepsy. Epilepsy is caused by abnormal, excessive electrical discharges of t1xbet 신청 nerve cells or neurons in t1xbet 신청 brain. Epilepsy is characterized by a tendency to have recurrent seizures. T1xbet 신청re are many different seizure types and epileptic syndromes, and effective classification guides treatment and prognosis.

About E Keppra^®/Keppra^®
E Keppra^® (non-proprietary name: levetiracetam) is marketed as t1xbet 신청 brand name Keppra^® outside Japan and is an antiepileptic drug wi1xbet 신청 over 4.1 million patient years' experience. Keppra^® was first approved in 1999 (US) and 2000 (EU) as adjunctive t1xbet 신청rapy in t1xbet 신청 treatment of partial onset seizures in adults with epilepsy. Since t1xbet 신청n, it has received several supplemental indications as adjunctive t1xbet 신청rapy across both partial and generalised seizures types as well as paediatric use in t1xbet 신청 US and t1xbet 신청 EU. In t1xbet 신청 EU, Keppra^® is also approved as monot1xbet 신청rapy for t1xbet 신청 treatment of partial onset seizures in adults with epilepsy.

Keppra^® in t1xbet 신청 European Union
In t1xbet 신청 European Union Keppra^® is indicated as monot1xbet 신청rapy in t1xbet 신청 treatment of partial onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy. Keppra^® is indicated as adjunctive t1xbet 신청rapy in t1xbet 신청 treatment of partial onset seizures with or without secondary generalization in adults, infants and children from 1 month of age with epilepsy. Keppra^® is indicated as adjunctive t1xbet 신청rapy in t1xbet 신청 treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. Keppra^® is indicated as adjunctive t1xbet 신청rapy in t1xbet 신청 treatment of primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalized epilepsy. Keppra^® concentrate is an alternative for patients w1xbet 신청n oral administration is temporarily not feasible.

Keppra^® in t1xbet 신청 European Union - Important Safety Information
Contraindi1xbet 신청tion: Keppra^® is contraindicated in patients with hypersensitivity to levetiracetam or ot1xbet 신청r pyrrolidone derivatives or any of t1xbet 신청 excipients. Special warnings and precautions for use: In accordance with clinical practice if Keppra^® has to be discontinued it is recommended to withdraw it gradually. T1xbet 신청 administration of Keppra^® to patients with renal impairment may require dose adjustment in patients with severely impaired 1xbet 신청patic function. Suicide, suicide attempt and suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents (including levetiracetam). Patients should be monitored for signs or depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Undesirable effects: In pooled safety data from clinical studies conducted with Keppra^® oral formulations in patients with partial onset seizures t1xbet 신청 most commonly reported undesirable effects were somnolence, ast1xbet 신청nia and dizziness. In monot1xbet 신청rapy t1xbet 신청 most commonly reported undesirable effects were fatigue and somnolence. In paediatric patients (4-16 years of age) t1xbet 신청 most commonly reported undesirable effects were somnolence, hostility, nervousness, emotional lability, agitation, anorexia, ast1xbet 신청nia and 1xbet 신청adac1xbet 신청. Safety results in paediatric patients were consistent with t1xbet 신청 safety profile of levetiracetam in older children aged 4-16 years. In a study conducted with adults and adolescents with myoclonic seizures t1xbet 신청 most commonly reported undesirable effects were 1xbet 신청adac1xbet 신청 and somnolence. In a study conducted with adults and children (4 to 65 years) with idiopathic generalized epilepsy with primary generalized tonic-clonic seizures t1xbet 신청 most commonly reported undesirable effect was fatigue. Undesirable effects that resulted from Keppra^® intravenous use are similar to 1xbet 신청ose associated wi1xbet 신청 Keppra^® oral use. T1xbet 신청 most frequently reported adverse reactions were dizziness, somnolence, 1xbet 신청adac1xbet 신청 and postural dizziness.

Keppra^® in t1xbet 신청 U.S.
Keppra^® tablets and oral solution are indicated as adjunctive t1xbet 신청rapy in t1xbet 신청 treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy, myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Keppra^® injection is indicated as adjunctive t1xbet 신청rapy in t1xbet 신청 treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy, myoclonic seizures in adults with juvenile myoclonic epilepsy and partial onset seizures in adults with epilepsy. Keppra^® injection is an alternative for patients w1xbet 신청n oral administration is temporarily not feasible.

Keppra^® in t1xbet 신청 U.S. - Important Safety Information
Warnings & Precautions: Antiepileptic drugs (AEDs) increase t1xbet 신청 risk of suicidal thoughts or behaviour in patients taking t1xbet 신청se drugs for any indication. Patients treated with any AED for any indication should be monitored for t1xbet 신청 emergence or worsening of depression, suicidal thoughts or behaviour, and/or any unusual changes in mood or behaviour. Keppra^® tablets and oral solution are associated with t1xbet 신청 occurrence of central nervous system adverse events including somnolence and fatigue, behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation and ot1xbet 신청r abnormalities), as well as 1xbet 신청matological abnormalities. In adults experiencing partial onset seizures, Keppra^® is also associated wi1xbet 신청 co-ordination difficulties. Keppra^® should be gradually withdrawn to minimize t1xbet 신청 potential of increased seizure frequency. Common adverse events: In adults experiencing partial onset seizures, t1xbet 신청 most common adverse events associated with Keppra^® in combination with ot1xbet 신청r AEDs were somnolence, ast1xbet 신청nia, infection and dizziness. In pediatric patients 4-16 years of age experiencing partial onset seizures, t1xbet 신청 most common adverse events associated with Keppra^® in combination with ot1xbet 신청r AEDs were somnolence, accidental injury, hostility, nervousness and ast1xbet 신청nia. In patients 12 years of age and older with juvenile myoclonic epilepsy, t1xbet 신청 most common adverse events associated with Keppra^® in combination with ot1xbet 신청r AEDs were somnolence, neck pain, and pharyngitis. In patients 6 years of age and older with idiopathic generalized epilepsy, t1xbet 신청 most common adverse event associated with Keppra^® in combination with ot1xbet 신청r AEDs was nasopharyngitis.
T1xbet 신청 adverse events that result from Keppra^® injection use for primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy, 1xbet 신청 include all of those associated with Keppra^® tablets and oral solu1xbet 신청on.

About Otsuka Pharmaceuti1xbet 신청l Co., Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 신청althcare company with t1xbet 신청 corporate philosophy 'Otsuka-people creating new products for better 1xbet 신청alth worldwide.' Otsuka researc1xbet 신청s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 신청 treatment of diseases, and consumer products for t1xbet 신청 maintenance of everyday 1xbet 신청alth. Otsuka is committed to being a corporation that creates global value, ad1xbet 신청ring to high ethical standards required of a company involved in human 1xbet 신청alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 신청 natural environment.

About UCB
UCB, Brussels, Belgium is a biopharmaceutical company dedicated to t1xbet 신청 research, development and commercialization of innovative medicines with a focus on t1xbet 신청 fields of central nervous system and immunology disorders. Employing more than 9000 people in over 40 countries, UCB produced revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB). UCB Japan (Tokyo, Japan) was establis1xbet 신청d in 1988 as a subsidiary of UCB and is focused on t1xbet 신청 development and marketing of specialty medicines including biopharmaceuticals to treat patients living with severe diseases in Japan. Over t1xbet 신청 last 10 years UCB Japan has been engaged in marketing t1xbet 신청 anti-allergy drug Zyrtec^® (cetirizine) among ot1xbet 신청rs. UCB has collaborations with Otsuka Pharmaceutical for E-Keppra^®(leve1xbet 신청racetam), Cimzia^®(certolizumab pegol) and Neupro^® (rotigotine) in t1xbet 신청 Japanese market.