Products

Date: 2017-06-15

Type of information: Positive opinion for the granting of a Market Authorisation in the EU

Product name: polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1-3)-beta-D-galactopyranoside

Compound: polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1-3)-beta-D-galactopyranoside

Therapeutic area: Rare diseases - Neurological diseases

Action mechanism:

Company: SFL Regulatory Affairs Consulting (UK)

Disease: anti-MAG neuropathy

Latest news:

• On June 15, 2017, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1-3)-beta-D-galactopyranoside for treatment of anti-MAG neuropathy.

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:

Is general: Yes