Libmeldy Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

libmeldy

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - druga zdravila na živčnem sistemu - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Tecovirimat SIGA Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

tecovirimat siga

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirusi za sistemsko uporabo - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 in 5. tecovirimat siga should be used in accordance with official recommendations.