Mircera

Medicinal product

(Invented) name

Mircera

Active substance (s)

Metoksipolietilenglikolepoetinas beta

Strength

50 µg/0,3 ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B03XA03, Methoxy polyethylene glycol-epoetin beta

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2007-07-20

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

solution for injection	0.3 ml
Metoksipolietilenglikolepoetinas beta	50 µg

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
27397	29952	1029952	užpildytas švirkštas	0,3 ml N1		Receptinis	EU/1/07/400/008	Netiekiama	-	-	No	-	-
40928	54665	1054665	užpildytas švirkštas	0,3 ml N3		Receptinis	EU/1/07/400/023	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-07-20	Registruotas