Opgenra

Medicinal product

(Invented) name

Opgenra

Active substance (s)

Eptoterminas alfa

Strength

3,5 mg

Pharmaceutical form

milteliai implantuojamajai suspensijai

Route (s) of administration

vartoti į kaulus

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M05BC02, Eptotermin alfa

Marketing authorisation holder

Olympus Biotech (Ireland) Limited, Airija

Date of authorisation

2009-02-19

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

powder for suspension for implantation	1 vnt.
Eptoterminas alfa	3,5 mg

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
34040	36398	1036398	flakonas	N1+1		Receptinis	EU/1/08/489/001	Netiekiama	-	-	No	-	-
42787	56555	1056555	flakonas	N2+2		Receptinis	EU/1/08/489/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2009-02-19	Registruotas