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Date: 2012-04-06

Type of information:

Product name: adeno-associated viral vector of serotype 5 containing the human alanine-glyoxylate aminotransferase gene

Compound: adeno-associated viral vector of serotype 5 containing the human alanine-glyoxylate aminotransferase gene

Therapeutic area:

Action mechanism:

Company: Amsterdam Molecular Therapeutics (The Netherlands)

Disease: primary hyperoxaluria type 1

Latest news:

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: 2012-03-21

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes