Zutectra

Medicinal product

(Invented) name

Zutectra

Active substance (s)

Žmogaus hepatito B imunoglobulinas

Strength

500 TV

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BB04, Hepatitis B immunoglobulin

Marketing authorisation holder

Biotest Pharma GmbH, Vokietija

Date of authorisation

2009-11-30

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	1 ml
Žmogaus hepatito B imunoglobulinas	500 TV

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
39002	52685	1052685	užpildytas švirkštas	1 ml N5		Receptinis	EU/1/09/600/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-11-30	Registruotas