77 results
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Referral: Numeta G13%E and Numeta G16%E emulsion for infusion
Article 107i procedures
Status: CMDh final position, opinion/position date: 18/09/2013, Last updated: 27/09/2013Numeta G13%E and Numeta G16%E emulsion for infusion … Numeta G13%E to be suspended and … measures to be introduced for Numeta G16%E … -
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Press release: Numeta G13%E to be suspended and new risk-minimisation measures to be introduced for Numeta G16%E
CMDh, Last updated: 20/09/2013Numeta G13%E to be suspended and … measures to be introduced for Numeta G16%E … marketing authorisation of Numeta G13%E because of a risk of … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2013
PRAC, Last updated: 06/09/2013suspension and reformulation for Numeta G13%E and risk minimisation … minimisation measures for Numeta G16%E … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013
PRAC, Last updated: 14/06/2013New referral procedure for Numeta G13%E and G16%E … -
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Outcomes of imposed non-interventional post-authorisation safety studies
Last updated: 27/06/2022 -
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National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 80.05 KB | PDF
- Curriculum Vitae - 22.93 KB | PDF
quot;Contaminazione da alluminio in soluzioni di albumina umana: un monitoraggio … dell'attivatore della precallicreina in soluzioni di albumina umana" (Abs … -
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National expert: Eraldo Donnarumma, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 17.98 KB | PDF
PANORAMI E PERCORSI) "Doping: soluzione o inganno chimico? (BIF n.4/2006 … -
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National expert: Paola Minghetti, Italian Medicines Agency (updated)
- Declaration of interests - 81.41 KB | PDF
- Curriculum Vitae - 62.13 KB | PDF
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National expert: Armando Magrelli, Italian Medicines Agency (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 29.06 KB | PDF
Agency http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9 http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79 http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9 Con Soluzioni Con Srl (Italy) Main activities … -
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Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
Article 82
Status: Under evaluation, opinion/position date: 11/05/2022, Last updated: 14/09/2022 -
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Referral: Closamectin Pour-on Solution and associated names
ivermectin, closantel, Article 78
Status: European Commission final decision, opinion/position date: 08/10/2015, EC decision date: 22/03/2016, Last updated: 31/05/2016 -
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Referral: Fiprex
fipronil, Article 33
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 14/07/2014, Last updated: 14/08/2014 -
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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: 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, Last updated: 24/10/2017 -
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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: Veterinary medicinal products containing toltrazuril to be administered orally to chickens
toltrazuril, Article 35
Status: European Commission final decision, opinion/position date: 14/07/2022, EC decision date: 09/11/2022, Last updated: 14/12/2022 -
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Referral: Altrenogest
altrenogest, Article 35
Status: European Commission final decision, opinion/position date: 19/05/2016, EC decision date: 29/07/2016, Last updated: 08/09/2016 -
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Referral: Zyrtec
cetirizine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 30/05/2008, EC decision date: 06/10/2008, Last updated: 16/10/2008 -
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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: Baxter dialysis solutions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, Last updated: 20/11/2013 -
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Referral: Ciprofloxacin Hikma
ciprofloxacin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/01/2007, EC decision date: 11/06/2007, Last updated: 06/09/2007Ciprofloxacin Hikma 200mg/100ml Soluzione per Infusione Endovenosa … -
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Referral: Losec
omeprazole, associated names: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole, AstraZeneca, Zoltum, Article 30 referrals
Status: European Commission final decision, opinion/position date: 20/01/2010, EC decision date: 10/06/2010, Last updated: 19/09/2011 -
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Referral: Cydectin TriclaMox
moxidectin, triclabendazole, Article 13
Status: European Commission final decision, opinion/position date: 16/07/2013, EC decision date: 25/09/2013, Last updated: 18/10/2013TriclaMox 5 mg/ml + 200 mg/ml soluzione Pour-on per bovini Moxidectin … -
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Referral: Deltanil
deltamethrin, Article 33
Status: European Commission final decision, opinion/position date: 24/09/2013, EC decision date: 24/09/2013, Last updated: 11/10/2013FRANCE Deltanil 10 mg/ml soluzione Pour-on per bovini ed ovini …