1833 results
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Referral: Dectomax injectable solution and its associated names
doramectin, associated names: Dectomax 1% Injektionslösung für Rinder und Schafe, Dectomax Vet, Dectomax 1%, Dectomax 1% Injectable Solution, Prontax, Dectomax solution injectable, Dectomax Injectable Solution for Cattle and Sheep, Article 34
Status: European Commission final decision, opinion/position date: 08/12/2004, EC decision date: 29/03/2005, Last updated: 13/08/2014namesdoramectin Dectomax 1% Injektionslösung für Rinder … Schafe Dectomax Vet Dectomax 1% Dectomax 1% Injectable Solution Prontax … 33-35 1071 Wien Dectomax 1% Injektions- lösung für … -
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Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,
, Revision: 15, Authorised, Last updated: 18/07/2023
tumours have PD-L1 in at least 1% of the cells and no mutations … tumours have PD-L1 in at least 1% of the cells and no mutations … produce PD-L1 in at least 1% of cells, Libtayo given with … -
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Human medicine European public assessment report (EPAR): Pradaxa
Dabigatran etexilate mesilate, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 17/03/2008, Revision: 39, Authorised, Last updated: 22/03/2023in each group (less than 1%). The second study involved … Pradaxa group died (less than 1%), but two of these deaths were … -
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Human medicine European public assessment report (EPAR): Opdualag
nivolumab, Relatlimab, Melanoma
Date of authorisation: 15/09/2022,, Authorised, Last updated: 17/10/2022
tumour cell PD L1 expression < 1%. … -
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Human medicine European public assessment report (EPAR): Opdivo (updated)
nivolumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
Date of authorisation: 19/06/2015, Revision: 55, Authorised, Last updated: 08/09/2023have PD-L1 expression ≥ 1%. … -
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Human medicine European public assessment report (EPAR): Bridion (updated)
sugammadex, Neuromuscular Blockade
Date of authorisation: 25/07/2008, Revision: 22, Authorised, Last updated: 25/09/2023of treatments (less than 1%). In children and adolescents … the treatments (less than 1%). In children and adolescents … -
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Human medicine European public assessment report (EPAR): Jakavi
ruxolitinib (as phosphate), Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease
Date of authorisation: 23/08/2012, Revision: 28, Authorised, Last updated: 31/07/2023155) compared with less than 1% of patients given placebo … compared with less than 1% of patients given placebo … treatment, compared with 1% (1 out of 112) of patients … -
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Human medicine European public assessment report (EPAR): Hemlibra
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,
, Revision: 15, Authorised, Last updated: 17/05/2023
have: severe disease (FVIII < 1%) moderate disease (FVIII ≥ 1% and ≤ 5%) with severe bleeding … -
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Human medicine European public assessment report (EPAR): Biktarvy
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018, Revision: 16, Authorised, Last updated: 28/04/2023equal to 50 copies/ml was 1% (3 out of 282) of patients … equal to 50 copies/ml was 1% (3 out of 282) of patients … -
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Human medicine European public assessment report (EPAR): Tamiflu
oseltamivir, Influenza, Human
Date of authorisation: 20/06/2002, Revision: 42, Authorised, Last updated: 24/03/2023carried out during an epidemic, 1% of the people taking Tamiflu … -
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Human medicine European public assessment report (EPAR): Vocabria
Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 8, Authorised, Last updated: 12/01/2023
out of 522) compared with 1% of patients (5 out of 523 … out of 522) compared with 1% of patients (5 out of 523 … -
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Human medicine European public assessment report (EPAR): Imlygic
talimogene laherparepvec, Melanoma
Date of authorisation: 16/12/2015, Revision: 13, Authorised, Last updated: 15/12/2022treatment, compared with around 1% (1 out of 86) of patients … treatment, compared with around 1% (1 out of 86) of patients … -
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Human medicine European public assessment report (EPAR): Roteas
edoxaban tosilate, Stroke; Venous Thromboembolism
Date of authorisation: 19/04/2017, Revision: 10, Authorised, Last updated: 09/06/2022patients given Roteas and 1% of those given warfarin … -
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Human medicine European public assessment report (EPAR): Conbriza
bazedoxifene, Osteoporosis, Postmenopausal
Date of authorisation: 17/04/2009, Revision: 15, Authorised, Last updated: 23/03/2021placebo it was reduced by over 1%. In both main studies the … -
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National expert: Indre Sveikauskaite-Radučienė, State Medicines Control Agency (updated)
- Declaration of interests - 39.45 KB | PDF
- Curriculum Vitae - 29.14 KB | PDF
of Naftifine Hydrochloride 1% medical nail lacquers. The … vitro characterization of 1% naftifine hydrochloride medical … Development and characterization of 1% naftifine hydrochloride medical … -
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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: 11/10/2013Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and … Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose … Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and … -
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Human medicine European public assessment report (EPAR): Xevudy (updated)
Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021,, Revision: 9, Authorised, Last updated: 13/09/2023
illness becoming severe, 1% of those treated with Xevudy … illness becoming severe, 1% of those treated with Xevudy … -
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Human medicine European public assessment report (EPAR): Rekambys (updated)
rilpivirine, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 8, Authorised, Last updated: 05/09/2023
out of 522) compared with 1% of patients (5 out of 523 … out of 522) compared with 1% of patients (5 out of 523 … -
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Human medicine European public assessment report (EPAR): Evusheld
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Revision: 3, Authorised, Last updated: 18/08/2023
breakthrough COVID-19, compared with 1% (17 out of 1,731) of the … breakthrough COVID-19, compared with 1% (17 out of 1,731) of the … -
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Proveblue
methylthioninium chloride, Methemoglobinemia
Date of authorisation: 06/05/2011, Revision: 26, Authorised, Last updated: 10/07/2023Methylthioninium Chloride Injection USP 1% w/v. Methylthioninium chloride … Methylthioninium Chloride Injection USP 1% w/v. Methylthioninium chloride … -
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Human medicine European public assessment report (EPAR): Lixiana
edoxaban tosilate, Stroke; Venous Thromboembolism
Date of authorisation: 19/06/2015, Revision: 17, Authorised, Last updated: 06/07/2023patients given Lixiana and 1% of those given warfarin … -
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Human medicine European public assessment report (EPAR): Cholib
fenofibrate, simvastatin, Dyslipidemias
Date of authorisation: 26/08/2013, Revision: 15, Authorised, Last updated: 20/04/2023cholesterol (6% increase versus a 1% decrease). Two further studies … cholesterol (6% increase versus a 1% decrease). Two further … -
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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: 4, Authorised, Last updated: 21/03/2023
by a scan, compared with 1% (1 out of 96) of patients … by a scan, compared with 1% (1 out of 96) of patients … -
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Human medicine European public assessment report (EPAR): Intrarosa
Prasterone, Postmenopause
Date of authorisation: 08/01/2018,, Revision: 6, Authorised, Last updated: 03/11/2022
Intrarosa compared with about 1% and 2% with placebo. There … Intrarosa compared with about 1% and 2% with placebo. There … -
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Human medicine European public assessment report (EPAR): Nilemdo
Bempedoic acid, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 01/04/2020,, Revision: 6, Authorised, Last updated: 08/04/2022
compared with a decrease of 1% and an increase of 5% respectively …