Request to the CVMP for classification of a veterinary medicinal product as intended for a limited market according to Article 4(29) and for eligibility for authorisation according to Article 23 (Applications for limited markets)

Orphan designation: sargramostim Treatment of hereditary orotic aciduria, 28/06/2024 Positive

Metamizole-containing medicinal products article 107i referral - Timetable for the procedure

Orphan designation: nizubaglustat Treatment of GM1 gangliosidosis, 28/06/2024 Positive

Orphan designation: afatinib Treatment of complex regional pain syndrome, 28/06/2024 Positive

Orphan designation: Topiramate Treatment of neonatal encephalopathy, 28/06/2024 Positive

Orphan designation: Complement factor H Treatment of C3 glomerulopathy, 28/06/2024 Positive

Orphan designation: L-methionine Treatment of pulmonary alveolar proteinosis, 28/06/2024 Positive

Orphan designation: sargramostim Treatment of pulmonary alveolar proteinosis, 28/06/2024 Positive

Orphan designation: (R)-3-(1-Cyclopropyl-3-(2-fluoro-4-(trifluoromethoxy)benzyl)ureido)piperidine-1-carboxamide Treatment of hyperphenylalaninaemia, 28/06/2024 Positive