Products

Date: 2016-12-12

Type of information: Granting of the orphan status in the EU

Product name: propranolol

Compound: propranolol

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism: beta-blocker/antiinflammatory agent. 

Company: The Anticancer Fund (Belgium)

Disease: soft tissue sarcoma

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 propranolol for treatment of soft tissue sarcoma,

 

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:

Is general: Yes