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Date: 2011-06-21

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

Product name: human dermal fibroblasts cultured on a bioresorbable polyglactin mesh

Compound: human dermal fibroblasts cultured on a bioresorbable polyglactin mesh

Therapeutic area: Rare diseases - Genetic diseases - Dermatological diseases

Action mechanism:

The medicine is made up of fibroblasts that have been grown in the laboratory to be used as a skin substitute. Fibroblasts are specialised cells in the inner layers of the skin that produce proteins such as collagen and form the connective tissue, the tissue that supports the skin and internal organs. The fibroblasts in this medicine have been grown on a mesh scaffold so that they can be used like a skin graft. Once implanted, the mesh dissolves naturally and the fibroblasts settle into the wound, where they are expected to help the healing process by providing proteins that promote the growth of blood vessels and epidermis.

Company: TMC Pharma Services (UK)

Disease:

epidermolysis bullosa

Latest news:

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: 2011-06-21

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes