approval activities in europe

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22 MARKET NEWS Approval activities in Europe Zeneca's antineoplastic drug anastrozole [' Arimidex'] has been approved for marketing in Switzerland. l The price for 30 Img tablets will be SwFr390.75 ($US312). The cytoprotective agent amifostine ['Ethyol'; EssexlSchering Plough] has also been approved in that country for patients who receive cyclophosphamide and cisplatin treatment for ovarian cancer. Italian authorities have approved Centocor's antithrombotic abciximab ['Reopro'] for use in high-risk patients undergoing percutaneous transluminal coronary angioplasty. 2 Abciximab therapy in combination with aspirin and heparin is indicated for the prevention of cardiac complications in such patients. Other approvals in Italy include Organon's mirtazapine ['Remeron'] for the treatment of major depressive episodes, Ferring's somatropin 'Zomacton' in the 'Medi-lector' system, and the calcium antagonist nilvadipine, which will be marketed as 'Escor' and 'Nivadil' by Bracco and Dibra, respectively. In Germany, Takeda has applied for approval of its neuroprotective agent idebenone ['Arzkat'] for the treatment of patients with Alzheimer's disease. 3 1. Product approvals in Switzerland. Scrip: 20. No. 2148, 23 Jull9961. Italian product approvals. Saip: 20, No. 2148. 23 Jul 1996 3. Takeda seeks idebenone approval in Germany. Scrip: 20. No. 2148. 23 Jull996 '00"1O:l5 Inpharma- 3 Aug 1l1li6 No. 1048 0156-270319611048-000221$01.00° Adlalnternatlonal Limited 1996. All rights

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Page 1: Approval activities in Europe

22 MARKET NEWS Approval activities in Europe

Zeneca's antineoplastic drug anastrozole [' Arimidex'] has been approved for marketing in Switzerland. l The price for 30 Img tablets will be SwFr390.75 ($US312). The cytoprotective agent amifostine ['Ethyol'; EssexlSchering Plough] has also been approved in that country for patients who receive cyclophosphamide and cisplatin treatment for ovarian cancer.

Italian authorities have approved Centocor's antithrombotic abciximab ['Reopro'] for use in high-risk patients undergoing percutaneous transluminal coronary angioplasty.2 Abciximab therapy in combination with aspirin and heparin is indicated for the prevention of cardiac complications in such patients. Other approvals in Italy include Organon's mirtazapine ['Remeron'] for the treatment of major depressive episodes, Ferring's somatropin 'Zomacton' in the 'Medi-lector' system, and the calcium antagonist nilvadipine, which will be marketed as 'Escor' and 'Nivadil' by Bracco and Dibra, respectively.

In Germany, Takeda has applied for approval of its neuroprotective agent idebenone ['Arzkat'] for the treatment of patients with Alzheimer's disease.3

1. Product approvals in Switzerland. Scrip: 20. No. 2148, 23 Jull9961. Italian product approvals. Saip: 20, No. 2148. 23 Jul 1996 3. Takeda seeks idebenone approval in Germany. Scrip: 20. No. 2148. 23 Jull996 '00"1O:l5

Inpharma- 3 Aug 1l1li6 No. 1048 0156-270319611048-000221$01.00° Adlalnternatlonal Limited 1996. All rights ~