The Agency Italian drug revoked the marketing authorizations of several generics based omeprazole f

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Members: 2114 newest member mauropic57 Members | JOIN Search Pills Downloads Articles Links News Pictures Comments regional Revocation AIFA numerous generics containing omeprazole Submitted February 24, 2010 by admin. - Profession - reports to:
The Agency Italian drug revoked the marketing authorizations of several generics based omeprazole for inaffidabilit of certain clinical trials conducted bioequivalence dell'Omeoprazolo 6 to 10 April 2009 at the Clinical Research Center of the University Foundation 'G. D' Annunziodi Chieti, Centre for the study of aging. ragweed Here by way of example DETERMINATION AIFA December 2, 2009: Withdrawal of the marketing authorization for the medicinal product "Omeprazole RK." (09A15036) source: http://www.iuritalia.com/GU/20091217/GU% 20n.293% 20del% 2017-12-2009 / 021.htm THE EXECUTIVE Office ragweed authorizations workshops of the art. 48 of the Decree-Law of 30 September ragweed 2003, n. 269, converted into Law 24 November 2003, n. 326, which established the Italian Medicines Agency, hereinafter referred to AIFA, the Order of the Minister of Health in consultation ragweed with the Ministers of Public Service and Economy and Finance dated 20 September 2004, n. 245, laying down rules on the organization and operation of AIFA; Having regard to Regulation for the organization, ragweed administration and the staff of the Italian Drug published in the Official Gazette no. 254 of 31 October 2009; Given the determination Directorial of 29 May 2009, by which and 'was awarded to Dr. Renato Massimi the post of director of the Office authorizations workshops; View the 7 August 1990, n. 241 and subsequent amendments and additions; Given the legislative decree of 24 April 2006, no. 219, in particular art. 141; Due to the communication of the Office of the marketing authorization (MA) AIFA prot. AIFA. AIC / 68986 of 07.07.2009, received on 07.09.2009, prot. n. 70178 with which 'was required in this office to take any action under its jurisdiction, pursuant to art. 141, paragraph 3 of Legislative ragweed Decree no. 219/2006, given that bioequivalence studies submitted in support of applications for marketing authorization for the medicinal product concerned, were not conducted in accordance 'with the existing rules and not respect the principles and guidelines of the Rules of good clinical practice (GCP ) and that the results are not reliable; Given the known prot. n. 51146-P / I.1.cn1 / 138 of 19 May 2009 and prot. 54841-P / I.1.cn1 ragweed / 138 of 28 May 2009 activities of the Office 'GCP inspections, attached to such notification (Annex 2 and 3), which shows in particular that the specific inspections on clinical bioequivalence of' omeprazole study CRC - 022 -06 and CRC - 029-06, conducted 6 to 10 April 2009 at the Clinical Research Center (CRC) of the Foundation University '"G. D'Annunzio" of Chieti, Centre for the study of aging (Ce.SI), were highlighted critical deviations from the principles and guidelines of good clinical practice standards set by Community legislation; Given the challenge of the facts submitted to the company by order prot. AIFA / UAO / 77731 / P / I.5.ia4 of 29/07/2009 pursuant to art. 141, paragraphs 3 and 4 of the legislative decree of 24 April 2006, no. 219; Having held the hearing procedure in art. 141, paragraph 4, of Legislative Decree 24 April 2006, no. 219, which ended on 22 September 2009; Regard to the opinion of the Legal AIFA of 16 October 2009, which reaffirms the revocation for violation found and sanctioned by paragraph 3 of article. 141 of Legislative Decree no. 219/2006; Considering that the revocation of art. 141 of Legislative Decree 24 April 2006, no. 219 and 'was introduced directly during the transposition of Directive 2001/83 / EC and is not' art. 116 of the same; Considering that due to such deviations critical AIFA believes unreliable results of clinical trials bioequivalence study dell'Omeoprazolo CRC - 022-06 and CRC - 029-06, conducted 6 to 10 April 2009 at the Clinical Research Center ( CRC) of the Foundation University ragweed 'G. D 'Annunzio of Chieti, Centre for the study of aging (Ce.SI); (Editor's note: http://www.fondazioneunich.it/portal/Default.asp?p=28&m=0) Determines: E 'revoked, effective immediately, in accordance with