Following the go-live of Product Management Service (PMS) Product User Interface on 31 May 2024, the PMS team is available to answer your questions on PUI use during weekly 30-minute sessions.
Following the go-live of Product Management Service (PMS) Product User Interface on 31 May 2024, the PMS team is available to answer your questions on PUI use during weekly 30-minute sessions.
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Kinpeygo. The marketing authorisation holder for this medicinal …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent. The marketing authorisation holder for this medicinal …
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe haemophilia B in adults who do not have factor IX inhibitors (auto-antibodies …
EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older against Chikungunya. It is given as a single dose. Chikungunya (also called CHIK fever) is a …
14 new medicines recommended for approval; another seven medicines are recommended for extension of their therapeutic indications EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its May 2024 meeting. The CHMP recommended …
This CHMP reflection paper replaces the CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products (EMA/CHMP/BWP/303353/2010). Keywords: Creutzfeldt-Jakob disease, human transmissible spongiform …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances1 for the medicinal product Adzynma2, indicated for the treatment of …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cejemly, intended for the first-line treatment of metastatic non-small …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zegalogue, intended for the treatment of severe hypoglycaemia in patients …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional1 marketing authorisation for the medicinal product Durveqtix, intended for the treatment of severe and …
On 21 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Fluenz, intended for the prevention of influenza disease in children and …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product GalliaPharm, a radionuclide generator. GalliaPharm is not intended for …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ixchiq, intended for the prevention of chikungunya disease in adults 18 …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Apexelsin, intended for the treatment of metastatic breast cancer, …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Avzivi, intended for the treatment of carcinoma of the colon or rectum, …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pomalidomide Accord, intended for the treatment of multiple myeloma. The …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pomalidomide Zentiva, intended for the treatment of multiple myeloma. The …
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zegalogue, intended for the treatment of severe hypoglycaemia in patients …
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