Respreeza

Medicinal product

(Invented) name

Respreeza

Active substance (s)

Žmogaus alfa-1 proteinazės inhibitorius

Strength

~=4000 mg

Pharmaceutical form

milteliai ir tirpiklis infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02AB02, Alfa1 antitrypsin

Marketing authorisation holder

CSL Behring GmbH, Vokietija

Date of authorisation

2015-08-20

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

Powder and solvent for solution for infusion	1 vnt.
Žmogaus alfa-1 proteinazės inhibitorius	~=4000 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
100820	86931	1086931	flakonas	milteliai, tirpiklio flakonas (76 ml) ir filtruojamas perpylimo įrenginys 20/20 („Mix2Vial“) N1		Receptinis	EU/1/15/1006/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-08-20	Registruotas