148 results
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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP02-13-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 19/02/2021, Compliance check: XInvented name Benlysta Active substance belimumab … EMEA-000520-PIP02-13). 1.2. What is Benlysta / Belimumab and how is it … is it expected to work? Benlysta / Belimumab is authorised … -
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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP01-08-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 15/07/2016, Last updated: 23/09/2016, Compliance check: V, 16/11/2018Invented name Benlysta Active substance belimumab … investigation plan for belimumab (Benlysta) (EMEA-000520-PIP01-08-M05 … investigation plan for belimumab (Benlysta) (EMEA-000520-PIP01-08-M05 … -
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,
, Revision: 29, Authorised, Last updated: 18/01/2023
Benlysta Cancer Neoplasms Immune … Benlysta … EMA/204539/2021 EMEA/H/C/002015 Benlysta (belimumab) An overview of Benlysta and why it is authorised … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021
CHMP, Last updated: 26/03/2021Benlysta, Kaftrio, Kalydeco, Saxenda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019
CHMP, Last updated: 20/09/2019Bavencio, Benlysta, Docetaxel Zentiva, Dupixent … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 2017
CHMP, Last updated: 15/09/2017Name of medicine Benlysta INN belimumab Marketing-authorisation … -
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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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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2011
CHMP, Last updated: 20/05/2011Benlysta … following new medicines: • Benlysta (belimumab), from Glaxo Group … activity. The review for Benlysta began on 23 June 2010 with … -
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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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Human medicine European public assessment report (EPAR): Saphnelo
anifrolumab, Lupus Erythematosus, Systemic
Date of authorisation: 14/02/2022,, Revision: 1, Authorised, Last updated: 18/10/2022
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Human medicine European public assessment report (EPAR): Lupkynis
Voclosporin, Lupus Nephritis
Date of authorisation: 15/09/2022,, Authorised, Last updated: 20/09/2022
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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: 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: 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: 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