35 results
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National expert: Maria Grazia Evandri, Italian Medicines Agency (updated)
- Declaration of interests - 39.83 KB | PDF
- Curriculum Vitae - 37.07 KB | PDF
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Human medicine European public assessment report (EPAR): Byannli (previously Paliperidone Janssen-Cilag International)
paliperidone palmitate, Schizophrenia
Date of authorisation: 18/06/2020, Revision: 2, Authorised, Last updated: 18/02/2022 -
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National expert: Monica Bartolomei, Italian Medicines Agency (updated)
- Declaration of interests - 39.46 KB | PDF
- Curriculum Vitae - 33.4 KB | PDF
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National expert: Massimiliano Filosto, European Medicines Agency (updated)
- Declaration of interests - 44.71 KB | PDF
- Curriculum Vitae - 35.96 KB | PDF
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National expert: Maria Francesca Cometa, Italian Medicines Agency (updated)
- Declaration of interests - 39.94 KB | PDF
- Curriculum Vitae - 38.09 KB | PDF
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National expert: Gerardo Sarno, Italian Medicines Agency (updated)
- Declaration of interests - 40.13 KB | PDF
- Curriculum Vitae - 42.43 KB | PDF
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Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
Article 82
Status: European Commission final decision, opinion/position date: 08/12/2022, EC decision date: 28/03/2023, Last updated: 14/04/2023 -
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Referral: Procaine benzylpenicillin
Article 82
Status: Under evaluation, opinion/position date: 18/02/2022, Last updated: 20/02/2023 -
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Referral: Baytril injectable and generics
enrofloxacin, Article 35
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 01/09/2014, Last updated: 10/12/2014 -
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Referral: Tylosin injection for mastitis
tylosin, Article 35
Status: European Commission final decision, opinion/position date: 16/03/2017, EC decision date: 10/07/2017, Last updated: 31/07/2017 -
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Referral: Injectable veterinary medicinal products containing vitamin A for use in food producing species
Vitamin A (retinol and its esters), Article 35
Status: European Commission final decision, opinion/position date: 12/05/2021, EC decision date: 18/08/2021, Last updated: 27/09/2021 -
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Referral: Modified live porcine respiratory and reproductive syndrome (PRRS) virus vaccines
Porcine respiratory and reproductive syndrome virus vaccine (live), associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 15/04/2021, EC decision date: 13/07/2021, Last updated: 28/07/2021 -
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Referral: Ivermectin
ivermectin, Article 35
Status: European Commission final decision, opinion/position date: 05/06/2009, EC decision date: 01/10/2009, Last updated: 26/10/2009 -
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Referral: Moxidectin-containing veterinary medicines used in cattle, sheep and horses
moxidectin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 11/05/2017, Last updated: 24/10/2017 -
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Referral: Benzathine benzylpenicillin intended for administration to food-producing species
benzathine benzylpenicillin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 15/01/2003, EC decision date: 22/04/2003, Last updated: 26/07/2016 -
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Referral: Florgane
florfenicol, Article 33
Status: European Commission final decision, opinion/position date: 06/03/2013, EC decision date: 23/05/2013, Last updated: 10/07/2013Florgane 300 mg/ml sospensione iniettabile per bovini e suini florfenicol … -
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Referral: Resflor solution injectable and associated names
florfenicol, flunixin, Article 13
Status: European Commission final decision, opinion/position date: 07/10/2014, EC decision date: 05/12/2014, Last updated: 09/01/201516,5 mg/mL SOLUZIONE INIETTABILE per bovini Florfenicol … -
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Referral: Bleomycin
bleomycin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 12/03/2009, Last updated: 31/03/2009 -
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Referral: Nuflor Swine Once
florfenicol, associated names: PigFlor Once, Article 33
Status: European Commission final decision, opinion/position date: 07/02/2013, EC decision date: 16/05/2013, Last updated: 14/06/2013One, 450 mg/ml soluzione iniettabile per suini florfenicol Solution … -
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Referral: Doramectin
doramectin, Article 35
Status: European Commission final decision, opinion/position date: 12/06/2013, EC decision date: 06/09/2013, Last updated: 18/10/2013 -
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Referral: Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names
Butafosfan, Cyanocobalamin, Article 33 opinion/position date: 15/02/2023, EC decision date: 03/04/2023, Last updated: 25/04/2023 -
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Referral: Vey Tosal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names
Butafosfan, Cyanocobalamin, Article 33 opinion/position date: 15/02/2023, EC decision date: 03/04/2023, Last updated: 25/04/2023 -
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Referral: Quinolones
enrofloxacin, marbofloxacin, danofloxacin mesilate, danofloxacin, flumequine, amoxicillin, difloxacin hydrochloride, oxolinic acid, Colistin sulfate, Amoxicillin trihydrate, difloxacin, bromhexine, oxytetracycline hydrochloride, Article 35
Status: European Commission final decision, opinion/position date: 09/03/2010, EC decision date: 01/07/2010, Last updated: 16/07/2010 -
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Orphan designation: Donor lymphocyte preparation depleted of functional alloreactive T-cells for: Prevention of graft-versus-host disease
Date of designation: 05/09/2008, Withdrawn, Last updated: 28/02/2022 -
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Orphan designation: Ethanol for: Treatment of congenital venous malformations
Date of designation: 09/03/2004, Withdrawn, Last updated: 18/01/2016Etanolo (96 percento) (gel iniettabile) Trattamento delle malformazioni …