Products

Date: 2017-06-15

Type of information: Positive opinion for the granting of the orphan status in the EU

Product name: tirapazamine

Compound: tirapazamine

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism: cytotoxic agent

Company: Teclison (USA - NJ) PhaRA (Belgium)

Disease: hepatocellular carcinoma

Latest news:

• On June 15, 2017, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for tirapazamine for treatment of hepatocellular carcinoma.
• • On November 30, 2015, the FDA has granted orphan drug designation for tirapazamine for the  treatment of hepatocellular carcinoma.

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: 2015-11-30

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes