Holoclar

Medicinal product

(Invented) name

Holoclar

Active substance (s)

Gyvybingos autologinės žmogaus ragenos epitelio ląstelės

Strength

79000-316000 ląst./cm²

Pharmaceutical form

gyvo audinio ekvivalentas

Route (s) of administration

implantacija

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01XA19, Limbal stems cells, autologous

Marketing authorisation holder

Holostem S.r.l., Italija

Date of authorisation

2015-02-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Living tissue equivalent	1 cm²
Gyvybingos autologinės žmogaus ragenos epitelio ląstelės	79000-316000 ląst.

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
61500	75840	1075840	talpyklė	3,8 cm² N1		Receptinis	EU/1/14/987/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-02-17	Registruotas