Date: 2017-06-15
Type of information: Positive opinion for the granting of the orphan status in the EU
Product name: oxymetazoline hydrochloride
Compound: oxymetazoline hydrochloride
Therapeutic area: Neurological diseases - CNS diseases
Action mechanism:
Company: RDD Pharma (Israel)
Disease: spinal cord injury
Latest news: • On June 15, 2017, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for oxymetazoline hydrochloride for the treatment of spinal cord injury.
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:
