Moscardina Ema (2024)

1. European Medicines Agency - European Union

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Our Medicine finder above helps you find information on medicines authorised for human or veterinary use. You can find these by including the medicine's name or its active substance. It shows you information on centrally authorised medicines - medicines that EMA evaluated. You can also find information on herbal medicines.

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EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a medicine for treating patients with duch*enne muscular dystrophy whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene and who are able to walk.

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Update as of 21 May 2024The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now consider the Commission’s request, including the additional real-world data brought to the attention of the Commission during the decision-making process. In addition, as part of this review EMA will take into account the impact of the appellate judgment of the Court of Justice of the European Union in Case C-291/22 P.EMA will communicate further on 31 May 2024 as part of the CHMP Highlights.

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This medicine was designated as an orphan medicine for treatment of the Rett syndrome on 12 January 2024.

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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 Akantior1, intended for the treatment of Acanthamoeba keratitis, a severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia. Acanthamoeba keratitis is a rare disease primarily affecting contact lens wearers.

27 okt 2023 · EMA Accepts Marketing Authorization Application for Mirvetuximab Soravtansine in FRα+, Platinum-Resistant Ovarian Cancer. Oct 27, 2023. By ...
The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

— Le im- portanti osservazioni di Bassi e di Judouin sullii moscardina ... moscardina^ non essendo stata colà simile affezione giammai osservata. ... ema- nato dal ...

5 mei 2023 · It is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have been previously treated with.
It is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have been previously treated with...