131 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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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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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): Jakavi (updated)
ruxolitinib (as phosphate), Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease
Date of authorisation: 23/08/2012, Revision: 27, Authorised, Last updated: 17/01/2023 -
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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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Human medicine European public assessment report (EPAR): Inrebic
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,, 
, Revision: 3, Authorised, Last updated: 08/12/2021
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National expert: Francesco Onida, Italian Medicines Agency (updated)
- Declaration of interests - 81.89 KB | PDF
- Curriculum Vitae - 50.99 KB | PDF
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National expert: Francesco Rodeghiero, European Medicines Agency (updated)
- Declaration of interests - 82.47 KB | PDF
- Curriculum Vitae - 115.78 KB | PDF
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Referral: Soludox
doxycycline hyclate, Article 13
Status: European Commission final decision, opinion/position date: 12/06/2013, EC decision date: 12/08/2013, Last updated: 24/09/2013Netherlands Soludox 500 mg/g polvere da somministrare nell’acqua … Netherlands Acquadox 500 mg/g polvere da somministrare nell’acqua … -
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Referral: Doxyfar 50%
doxycycline hyclate, associated names: Soludox 500 mg/g, Soludox Vet, Soludox 433 mg/g, Doxy Ort 50%, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011Netherlands Soludox 500 mg/g polvere per uso in acqua di bevanda … Netherlands Soludox 500 mg/g polvere per uso in acqua di bevanda … -
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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: Strenzen 500/125-mg/g powder
amoxicillin, clavulanic acid, Article 33
Status: European Commission final decision, opinion/position date: 10/04/2013, EC decision date: 12/08/2013, Last updated: 19/09/2013STRENZEN 500/125 mg/g polvere per somministrazione in … -
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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: Girolan and its associated name Apralan
apramycin sulfate, associated names: Apralan, Article 34
Status: European Commission final decision, Last updated: 15/06/2018Italy Apralan Solubile polvere per soluzione orale per … -
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Referral: Veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and, or poultry
lincomycin, spectinomycin, associated names: Please see Annex I, Article 35
Status: European Commission final decision, opinion/position date: 19/05/2016, EC decision date: 22/08/2016, Last updated: 16/09/2016 -
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Referral: Linco-Spectin 100 and associated names
lincomycin, spectinomycin, Article 34
Status: European Commission final decision, opinion/position date: 10/04/2014, EC decision date: 11/07/2014, Last updated: 04/09/2014Roma Italy LINCOSPECTIN Polvere orale per uso in acqua da … -
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Referral: Colistin oral
colistin, Article 35
Status: European Commission final decision, opinion/position date: 11/12/2014, EC decision date: 16/03/2015, Last updated: 13/04/2015 -
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National expert: Marek Jutel, European Medicines Agency (updated)
- Declaration of interests - 82.39 KB | PDF
- Curriculum Vitae - 135.88 KB | PDF
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Orphan designation: Tobramycin for: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of designation: 17/03/2003, Positive, Last updated: 01/07/2019 -
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Orphan designation: Beta-artemether, lumefantrine for: Treatment of malaria
Date of designation: 28/01/2010, Positive, Last updated: 25/02/2010