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Medicines European Medicines Agency

Medicine name Filter. Active substance / international non-proprietary name (INN) / common name

Actived: 8 days ago

URL: https://www.ema.europa.eu/en/medicines

Medicines European Medicines Agency

(7 days ago) Veterinary medicine European public assessment report (EPAR): Innovax-ND-IBD (updated) Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus, Chicken; Embryonated chicken eggs. Date of authorisation: 22/08/2017, Revision: 5, Authorised, Last updated: 04/11

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Download medicine data European Medicines Agency

(1 days ago) A paediatric investigation plan (PIP) is a medicine development plan aimed at ensuring the necessary data are obtained through studies in children to support a medicine's authorisation for use in children. The marketing authorisation applicant is responsible for submitting this plan to EMA's Paediatric Committee (PDCO), which agrees or refuses

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National registers of authorised medicines European

(8 days ago) 32 rows · The European Medicines Agency (EMA) has compiled a list of national medicine registers in …

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Authorisation of medicines European Medicines Agency

(2 days ago) From lab to patient: journey of a medicine. Follow the journey of a medicine for human use assessed by EMA in this interactive timeline.It explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and …

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What we publish on medicines and when European …

(1 days ago) 4–5 weeks after CHMP opinion. Medicines search: EPARs (on medicine page under 'Assessment history') Re-examinations. After the European Commission (EC) decision, depending on the outcome of the re-examination, the same set of documents as for positive or negative opinions on extension of indication will be published.

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The European regulatory system for medicines

(6 days ago) medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials and the conduct of inspections of medicines’ manufacturers and compliance with good clinical practice (GCP), good manufacturing practice (GMP),

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Celsunax European Medicines Agency

(8 days ago) The medicine is used to help in the diagnosis of the following conditions in adults: movement disorders such as those in Parkinson’s disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles.

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Byooviz European Medicines Agency

(7 days ago) Byooviz is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula. The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces.

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Librela European Medicines Agency

(2 days ago) Librela is a solution for injection to be given subcutaneously (under the skin); the recommended dose depends on the dog’s weight, and is given once a month. The medicine can only be obtained with a prescription. For more information about using Librela, see the package leaflet or contact your veterinarian or pharmacist.

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Medicines European Medicines Agency

(3 days ago) Human medicine European public assessment report (EPAR): Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) (updated) lenalidomide hydrochloride monohydrate, Multiple Myeloma; Lymphoma, Follicular. Date of authorisation: 11/02/2021, , Revision: 2, Authorised, Last updated: 05/11/2021. List item.

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COVID-19: latest updates European Medicines Agency

(9 days ago) The meeting was the first of a series of bi-weekly meetings organised by ICMRA to allow medicine regulators worldwide to exchange information and build synergies for expediting COVID-19 medicine and vaccine development and approval and avoiding medicine shortages. EMA will chair every other meeting. 21/04/2020

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Human medicines: regulatory information European

(7 days ago) Follow the journey of a medicine for human use assessed by EMA in this interactive timeline.It explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and risks and monitors the safety of medicines.

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First-in-class medicine to treat aggressive form of breast

(Just Now) The medicine prolonged the overall survival (i.e. how long patients live) by approximately 5 months (11.8 months for sacituzumab govitecan compared to 6.9 months for treatment of physician’s choice) and the progression-free survival (i.e. how long patients live without their disease getting worse) by about 3 months (4.8 months for sacituzumab

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Minjuvi European Medicines Agency

(7 days ago) Minjuvi is a cancer medicine used first in combination with another medicine called lenalidomide, and then on its own, to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have an autologous stem cell transplantation (a transplant where the stem cells are collected from the patients themselves).

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Ozawade European Medicines Agency

(7 days ago) Ozawade is a medicine used to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnoea. Obstructive sleep apnoea is the repeated interruption of breathing during sleep due to airways becoming blocked.

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Resolor European Medicines Agency

(7 days ago) Resolor is a medicine that contains the active substance prucalopride. It is available as tablets (1 and 2 mg). What is Resolor used for? Resolor is used to treat symptoms of chronic (long-term) constipation in adults for whom laxatives (medicines that trigger bowel movements) do …

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Koselugo European Medicines Agency

(8 days ago) Koselugo is a medicine used to treat plexiform neurofibromas, benign (non-cancerous) tumours along the nerves, when they cause symptoms and cannot be removed by surgery in children from 3 years of age with neurofibromatosis type 1 (NF1). NF1 is rare, and Koselugo was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 31

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Research and development European Medicines Agency

(6 days ago) EMA offers medicine developers several opportunities for early dialogue and consultation before submitting a marketing authorisation application. This is intended to provide regulatory and scientific support to facilitate the preparation of applications and enable a …

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Search the website European Medicines Agency

(5 days ago) Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated) CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection

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Glossary European Medicines Agency

(Just Now) The protection of an approved medicine against competition from generic medicines that extends beyond the protection conferred by data exclusivity. During this period, applications for generics can be accepted and authorised, but the generic medicines cannot be placed on the market.

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What we do European Medicines Agency

(8 days ago) EMA cannot sponsor medicines or fund research studies for a specific medicine, nor can it force companies to research particular medicines or treatments for a particular condition.. Being a medicines regulator, EMA has to be neutral and cannot have a financial or other interest in any medicine being developed. However, EMA can, and does, publicise areas where there is a need for new …

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Abecma European Medicines Agency

(6 days ago) Abecma is a type of advanced therapy medicine called ‘gene therapy’. This type of medicine works by delivering genes into the body. Multiple myeloma is rare, and Abecma was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 April 2017.

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Spikevax (previously COVID-19 Vaccine Moderna) European

(8 days ago) This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

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COVID-19 Vaccine Janssen European Medicines Agency

(4 days ago) This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

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Lamivudine/Zidovudine Teva European Medicines Agency

(6 days ago) Lamivudine/Zidovudine Teva is a medicine that contains two active substances, lamivudine (150 mg) and zidovudine (300 mg).It is available as tablets. Lamivudine/Zidovudine Teva is a ‘generic medicine’. This means that Lamivudine/Zidovudine Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Combivir.

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Glossary European Medicines Agency

(Just Now) A network of European centres in the fields of pharmacoepidemiology and pharmacovigilance, which aims to strengthen the postauthorisation monitoring of medicines by facilitating the conduct of multicentre, independent, postauthorisation studies focusing on safety and on benefit-risk balance. It is coordinated by the European Medicines Agency.

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Environmental risk assessment of veterinary medicines

(5 days ago) The phase I assessment determines the environmental exposure of the medicine and the need for an ecotoxicological assessment.It considers the medicine's active substance and excipients, its method of administration, target species and proposed pattern of use.It is mandatory for all veterinary medicines.. Examples of veterinary medicines whose ERA ends in phase I are those with a predicted

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Orphan medicine European Medicines Agency

(3 days ago) A medicine for the diagnosis, prevention or treatment of a life-threatening chronically debilitating condition that is rare (affecting not more than five in 10,000 people European Union) where unlikely to generate sufficient profit justify research and development costs. More information can be found under 'Orphan designation: Overview'.

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Meeting highlights from the Committee for Medicinal

(7 days ago) Nine new medicines recommended for approval. EMA’s human medicines committee recommended nine medicines for approval at its September 2021 meeting.The Committee adopted a positive opinion for Artesunate Amivas* (artesunate), for the initial treatment of severe malaria in adults and children. This medicine has an orphan designation because malaria has a low prevalence in the European Union.

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Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

(Just Now) This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor.

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Buying medicines online European Medicines Agency

(Just Now) Buying medicines online. In the European Union (EU), it is possible to buy medicines online. Patients should only buy medicines from online retailers registered with the national competent authorities in the EU Member States, to reduce the risk of buying sub-standard or falsified medicines. The European Commission has introduced a common logo

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Medicines European Medicines Agency

(5 days ago) Human medicine European public assessment report (EPAR): Fulphila (updated) pegfilgrastim, Neutropenia Date of authorisation: 20/11/2018, , , Revision: 7, Authorised, Last updated: 26/07/2021 . List item. Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)

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ANNUAL REPORT 2020

(4 days ago) ANNUAL REPORT 2020 2 MISSION STATEMENT The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines,

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Forxiga ( dapagliflozin

(5 days ago) Forxiga is a medicine used to treat adults with type 2 diabetes, heart failure and chronic (long-term) kidney disease. In type 2 diabetes, Forxiga is used in adults whose condition is not controlled well enough . It is used with appropriate diet and exercis e in patients who …

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Truxima EPAR Medicine Overview

(5 days ago) Truxima is a medicine used in adults to treat the following blood cancers and inflammatory conditions: • follicular lymphoma and diffuse large B cell non -Hodgkin’s lymphoma (two types of non -Hodgkin’s lymphoma, a blood cancer)

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Renin-angiotensin-system (RAS)-acting agents European

(7 days ago) Restriction of combined use of medicines affecting the renin-angiotensin system (RAS) On 23 May 2014 the European Medicines Agency's Committee for Medicinal Products for Human Use endorsed restrictions on combining different classes of medicines that act on the renin-angiotensin system (RAS), a hormone system that controls blood pressure and the volume of fluids in the body.

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CMDh European Medicines Agency

(2 days ago) Coordination Group for Mutual Recognition and Decentralised Procedures - Human: the group responsible examination coordination of questions relating to marketing authorisation human medicines in two or more Member States accordance with mutual recognition decentralised procedure. More information can be found under 'Coordination Human (CMDh)'.

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Leqvio (inclisiran

(4 days ago) Leqvio is a medicine used to reduce cholesterol in the blood. It is used in adults with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, includ ing cholesterol, in the blood). It should be used with a low -fat diet.

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Zercepac European Medicines Agency

(8 days ago) Zercepac is a cancer medicine used to treat the following conditions: early breast cancer (when the cancer has spread within the breast or to the lymph nodes [‘glands’] under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.

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Imatinib Koanaa European Medicines Agency

(5 days ago) Imatinib Koanaa is a cancer medicine for treating adults and children with: chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control. Imatinib Koanaa is used when the patients are ‘Philadelphia chromosome positive’ (Ph+).

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EMA starts rolling review of COVID-19 Vaccine (Vero Cell

(8 days ago) EMA’s human medicines committee has started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd.The EU applicant for this medicine is Life'On S.r.l. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies.

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Medical devices European Medicines Agency

(Just Now) Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level. The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the European Medicines Agency (EMA) and national

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by the Committee for Medicinal Products for Human Use

(1 days ago) Entries are removed from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website. Information on CHMP opinions is also published in the monthly CHMP highlights.

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Blenrep ( belantamab mafodotin

(5 days ago) Blenrep is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow) . It is given to adults who have received at least four previous treatments and whose dis ease does not respond to treatment with at least one proteasome inhibitor , one immunomodulatory agent, and an anti-CD38

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Careers European Medicines Agency

(5 days ago) Careers. A career at the European Medicines Agency (EMA) offers candidates interesting and challenging work that brings value to European citizens and a diverse and stimulating working environment, while enjoying attractive benefits and a healthy work-life balance. EMA is staffed mainly by temporary and contract agents recruited through open

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Irbesartan Teva European Medicines Agency

(5 days ago) Irbesartan Teva is a medicine that contains the active substance irbesartan. It is available as white tablets (75, 150 and 300 mg). Irbesartan Teva is a ‘generic medicine’. This means that Irbesartan Teva is similar to a ‘reference medicine’ already authorised in …

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