Emend (aprepitant) supply shortage

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate Treatment of mucopolysaccharidosis type I, 22/09/2016 Positive

Veterinary medicines European public assessment report (EPAR): YURVAC RHD, Rabbit haemorrhagic disease virus, capsid protein antigen, recombinant, Status: Authorised

Membership list: HMA-EMA joint Big Data Steering Group

Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

Orphan designation: 3,3-Dimethyl-N-(6-methyl-5-{[2-(1-methyl-1H-pyrazol-4-yl)pyridine-4-yl]oxy}pyridine-2-yl)-2-oxopyrrolidine-1-carboxamide hydrochloride hydrate Treatment of tenosynovial giant cell tumour, localised and diffuse type, 13/12/2023 Positive

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive