Prialt

Medicinal product

(Invented) name

Prialt

Active substance (s)

Zikonotidas

Strength

100 µg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į povoratinklinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02BG08, Ziconotide

Marketing authorisation holder

Esteve Pharmaceuticals GmbH, Vokietija

Date of authorisation

2005-02-21

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 infusion	1 ml
Zikonotidas	100 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
27861	30403	1030403	flakonas	1 ml N1		Receptinis	EU/1/04/302/001	Netiekiama	-	-	No	-	-
27862	30404	1030404	flakonas	2 ml N1		Receptinis	EU/1/04/302/002	Netiekiama	-	-	No	-	-
27863	30405	1030405	flakonas	5 ml N1		Receptinis	EU/1/04/302/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-02-21	Registruotas