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Akademický článek

Early Access for Medicines in ITALY: The Case of Ruxolitinib for Patients with Graft-Versus-Host Disease.

Autor: Gozzo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, 95125 Catania, Italy., Leotta S; Haematology and BMT Unit, University Hospital of Catania, 95125 Catania, Italy., Romano GL; Faculty of Medicine and Surgery, University of Enna 'Kore', Piazza dell'Università, 94100 Enna, Italy., Vetro C; Haematology and BMT Unit, University Hospital of Catania, 95125 Catania, Italy., Duminuco A; Haematology and BMT Unit, University Hospital of Catania, 95125 Catania, Italy., Milone G; Haematology and BMT Unit, University Hospital of Catania, 95125 Catania, Italy., Cupri A; Haematology and BMT Unit, University Hospital of Catania, 95125 Catania, Italy., Palumbo FE; Haematology and BMT Unit, University Hospital of Catania, 95125 Catania, Italy., Brancati S; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, 95125 Catania, Italy., Ruscica R; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, 95125 Catania, Italy., Longo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, 95125 Catania, Italy., Vitale DC; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, 95125 Catania, Italy., Fiorenza G; Department of Biomedical and Biotechnological Sciences, University of Catania, 95125 Catania, Italy., Lombardo GE; Faculty of Medicine and Surgery, University of Enna 'Kore', Piazza dell'Università, 94100 Enna, Italy., Lazzara A; Health Department, University Hospital of Catania, 95125 Catania, Italy., Di Raimondo F; Haematology and BMT Unit, University Hospital of Catania, 95125 Catania, Italy., Palumbo GA; Haematology and BMT Unit, University Hospital of Catania, 95125 Catania, Italy., Drago F; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, 95125 Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, 95125 Catania, Italy.; Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD), University of Catania, 95125 Catania, Italy.

Publikováno v: Journal of clinical medicine [J Clin Med] 2024 Jul 22; Vol. 13 (14). Date of Electronic Publication: 2024 Jul 22.

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Akademický článek

Severe Gastrointestinal Toxicity Following the Use of Gilteritinib: A Case Series and Analysis of Postmarketing Surveillance Data.

Autor: Gozzo L; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Nardo A; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Brancati S; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Judica A; Gastroenterology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Duminuco A; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Maugeri C; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Parisi M; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Longo L; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Vitale DC; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Ruscica R; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Romano GL; Department of Biomedical and Biotechnological Sciences, University of Catania, 95123 Catania, Italy., Mauro E; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Fiumara PF; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Palumbo GAM; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy.; Department of Scienze Mediche Chirurgiche e Tecnologie Avanzate 'G.F. Ingrassia', University of Catania, 95123 Catania, Italy., Di Raimondo F; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy.; Department of Chirurgia Generale e Specialità Medico-Chirurgiche, University of Catania, 95123 Catania, Italy., Vetro C; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Drago F; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, 95123 Catania, Italy.; Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD), University of Catania, 95123 Catania, Italy.

Publikováno v: Healthcare (Basel, Switzerland) [Healthcare (Basel)] 2023 May 18; Vol. 11 (10). Date of Electronic Publication: 2023 May 18.

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Akademický článek

The therapeutic value of treatment for multiple sclerosis: analysis of health technology assessments of three European countries.

Autor: Gozzo L; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Romano GL; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Brancati S; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Longo L; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Vitale DC; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Drago F; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.; Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD), University of Catania, Catania, Italy.

Publikováno v: Frontiers in pharmacology [Front Pharmacol] 2023 Apr 28; Vol. 14, pp. 1169400. Date of Electronic Publication: 2023 Apr 28 (Print Publication: 2023).

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Akademický článek

Pegylated Asparaginase-Induced Liver Injury: A Case-Based Review and Data From Pharmacovigilance.

Autor: Vetro C; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy., Duminuco A; Postgraduate School of Hematology, University of Catania, Catania, Italy., Gozzo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy., Maugeri C; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy., Parisi M; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy., Brancati S; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy., Longo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy., Vitale DC; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy., Romano GL; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Ciuni R; Department of Chirurgia Generale e Specialità Medico-Chirurgiche, University of Catania, Catania, Italy., Mauro E; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy., Fiumara PF; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy., Palumbo GAM; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy.; Postgraduate School of Hematology, University of Catania, Catania, Italy.; Department of Scienze Mediche Chirurgiche e Tecnologie Avanzate 'G.F. Ingrassia', University of Catania, Catania, Italy., Drago F; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy.; Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD), University of Catania, Catania, Italy., Di Raimondo F; Haematology Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico - S. Marco', Catania, Italy.; Department of Chirurgia Generale e Specialità Medico-Chirurgiche, University of Catania, Catania, Italy.

Publikováno v: Journal of clinical pharmacology [J Clin Pharmacol] 2022 Sep; Vol. 62 (9), pp. 1142-1150. Date of Electronic Publication: 2022 Apr 14.

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Akademický článek

Access to Innovative Neurological Drugs in Europe: Alignment of Health Technology Assessments Among Three European Countries.

Autor: Gozzo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Romano GL; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Brancati S; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Cicciù M; Department of Biomedical and Dental Sciences Morphological and Functional Images, University of Messina, AOU 'G. Martino', Messina, Italy., Fiorillo L; Department of Biomedical and Dental Sciences Morphological and Functional Images, University of Messina, AOU 'G. Martino', Messina, Italy., Longo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Vitale DC; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Drago F; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.; Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD), University of Catania, Catania, Italy.

Publikováno v: Frontiers in pharmacology [Front Pharmacol] 2022 Feb 04; Vol. 12, pp. 823199. Date of Electronic Publication: 2022 Feb 04 (Print Publication: 2021).

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Akademický článek

Venetoclax in Relapsed/Refractory Acute Myeloid Leukemia: Are Supporting Evidences Enough?

Autor: Brancati S; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, 95123 Catania, Italy., Gozzo L; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, 95123 Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, 95123 Catania, Italy., Romano GL; Department of Biomedical and Biotechnological Sciences, University of Catania, 95123 Catania, Italy., Vetro C; Haematology Unit, A.O.U. Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Dulcamare I; Haematology Unit, A.O.U. Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Maugeri C; Haematology Unit, A.O.U. Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Parisi M; Haematology Unit, A.O.U. Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy., Longo L; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, 95123 Catania, Italy., Vitale DC; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, 95123 Catania, Italy., Di Raimondo F; Haematology Unit, A.O.U. Policlinico 'G. Rodolico-S. Marco', 95123 Catania, Italy.; Department of Chirurgia Generale e Specialità Medico-Chirurgiche, University of Catania, 95123 Catania, Italy., Drago F; Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, University Hospital of Catania, 95123 Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, 95123 Catania, Italy.; Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD), University of Catania, 95123 Catania, Italy.

Publikováno v: Cancers [Cancers (Basel)] 2021 Dec 21; Vol. 14 (1). Date of Electronic Publication: 2021 Dec 21.

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Akademický článek

Off-Label Use of Venetoclax in Patients With Acute Myeloid Leukemia: Single Center Experience and Data From Pharmacovigilance Database.

Autor: Gozzo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Vetro C; Haematology Unit, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy., Brancati S; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy., Longo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy., Vitale DC; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy., Romano GL; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Mauro E; Haematology Unit, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy., Fiumara PF; Haematology Unit, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy., Maugeri C; Haematology Unit, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy., Parisi MS; Haematology Unit, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy., Dulcamare I; Haematology Unit, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy., Garibaldi B; Postgraduate School of Hematology, University of Catania, Catania, Italy., Duminuco A; Postgraduate School of Hematology, University of Catania, Catania, Italy., Palumbo GA; Haematology Unit, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy.; Department of Scienze Mediche Chirurgiche e Tecnologie Avanzate 'G.F. Ingrassia', University of Catania, Catania, Italy., Di Raimondo F; Haematology Unit, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy.; Department of Chirurgia Generale e Specialità Medico-Chirurgiche, University of Catania, Catania, Italy., Drago F; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, A.O.U. Policlinico 'G.Rodolico-S.Marco', Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.; Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD) University of Catania, Catania, Italy.

Publikováno v: Frontiers in pharmacology [Front Pharmacol] 2021 Nov 11; Vol. 12, pp. 748766. Date of Electronic Publication: 2021 Nov 11 (Print Publication: 2021).

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Akademický článek

Health Technology Assessment of Advanced Therapy Medicinal Products: Comparison Among 3 European Countries.

Autor: Gozzo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Romano GL; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Romano F; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Brancati S; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Longo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Vitale DC; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Drago F; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.; Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD) University of Catania, Catania, Italy.

Publikováno v: Frontiers in pharmacology [Front Pharmacol] 2021 Oct 08; Vol. 12, pp. 755052. Date of Electronic Publication: 2021 Oct 08 (Print Publication: 2021).

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Akademický článek

Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?

Autor: Brancati S; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Gozzo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Longo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Vitale DC; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Drago F; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.; Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD), University of Catania, Catania, Italy.

Publikováno v: Frontiers in immunology [Front Immunol] 2021 Jul 06; Vol. 12, pp. 661882. Date of Electronic Publication: 2021 Jul 06 (Print Publication: 2021).

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Akademický článek

Fertility Preservation in Female Pediatric Patients With Cancer: A Clinical and Regulatory Issue.

Autor: Brancati S; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Gozzo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy., Longo L; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Vitale DC; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy., Russo G; Pediatric Onco-Hematology, University Hospital of Catania, Catania, Italy., Drago F; Clinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.; Centre for Research and Consultancy in HTA and drug Regulatory Affairs (CERD), University of Catania, Catania, Italy.

Publikováno v: Frontiers in oncology [Front Oncol] 2021 Mar 09; Vol. 11, pp. 641450. Date of Electronic Publication: 2021 Mar 09 (Print Publication: 2021).

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