Date: 2016-12-12
Type of information: Granting of the orphan status in the EU
Product name: 68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2
Compound: 68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2
Therapeutic area: Cancer - Oncology - Diagnostic
Action mechanism:
Company: Advanced Accelerator Applications (France)
Disease: diagnosis of gastrointestinal stromal tumours
Latest news: * On 3-4 November 2016, the Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending the approval of the orphan medicinal product designation for 68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2 for diagnosis of gastrointestinal stromal tumours.
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: 2016-12-12
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: