25 results
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National expert: Maria Grazia Evandri, Italian Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 24.3 KB | PDF
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National expert: Monica Bartolomei, Italian Medicines Agency (updated)
- Declaration of interests - 79.87 KB | PDF
- Curriculum Vitae - 24.14 KB | PDF
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National expert: Maria Francesca Cometa, Italian Medicines Agency (updated)
- Declaration of interests - 80.13 KB | PDF
- Curriculum Vitae - 24.38 KB | PDF
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National expert: Massimiliano Filosto, European Medicines Agency (updated)
- Declaration of interests - 82.21 KB | PDF
- Curriculum Vitae - 25.05 KB | PDF
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National expert: Gerardo Sarno, Italian Medicines Agency (updated)
- Declaration of interests - 80.26 KB | PDF
- Curriculum Vitae - 32.74 KB | PDF
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National expert: Paul Knoebl, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 83.14 KB | PDF
- Curriculum Vitae - 144.46 KB | PDF
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Herbal medicinal product: Meliloti herba
Melilotus officinalis (L.) Lam., Melilot, F: Assessment finalised, Last updated: 24/04/2018 -
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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: 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: 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, EC decision date: 26/09/2017, Last updated: 24/10/2017 -
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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: 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: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011 -
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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: 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: Ethanol for: Treatment of congenital venous malformations
Date of first decision: 09/03/2004, Withdrawn, Last updated: 18/01/2016Etanolo (96 percento) (gel iniettabile) Trattamento delle malformazioni … -
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Orphan designation: Ethanol for: Treatment of congenital lymphatic malformations
Date of first decision: 09/03/2004, Withdrawn, Last updated: 14/01/2016Etanolo (96 percento) (gel iniettabile) Trattamento delle malformazioni … -
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Orphan designation: carmustine for: Treatment of glioma
Date of first decision: 05/03/2002, Withdrawn, Last updated: 17/10/2013Italian Carmustina (soluzione iniettabile per via intratumorale) Trattamento … -
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Public data from Article 57 database
Last updated: 16/02/2021 -
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Outcomes of imposed non-interventional post-authorisation safety studies
Last updated: 30/10/2017 -
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Guidance documents
Last updated: 31/01/2014