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Date: 2012-04-06

Type of information:

Product name: genistein sodium salt dihydrate

Compound: genistein sodium salt dihydrate

Therapeutic area:

Action mechanism:

Company: Axcentua Pharmaceuticals (Sweden)

Disease: mucopolysaccharidosis type III (Sanfilippo syndrome)

Latest news:

* On 7-8 February 2012 the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for genistein sodium salt dihydrate for treatment of mucopolysaccharidosis type III (Sanfilippo syndrome).

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes