Nimenrix

Medicinal product

(Invented) name

Nimenrix

Active substance (s)

A gr. Neisseria meningitidis polisacharidas/C gr. Neisseria meningitidis polisacharidas/W-135 gr. Neisseria meningitidis polisacharidas/Y gr. Neisseria meningitidis polisacharidas

Strength

5 µg/5 µg/5 µg/5 µg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07AH08, Meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2012-04-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

After reconstitution, 1 dose (0.5 ml) contains:	0.5 ml
A gr. Neisseria meningitidis polisacharidas	5 µg
C gr. Neisseria meningitidis polisacharidas	5 µg
W-135 gr. Neisseria meningitidis polisacharidas	5 µg
Y gr. Neisseria meningitidis polisacharidas	5 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
52297	66217	1066217	flakonas	N1 (ir 0,5 ml užpildytas švirkštas)	Receptinis	EU/1/12/767/001	Netiekiama	-	-	No	-	-
52298	66218	1066218	flakonas	N10 (ir 10 užpildytų švirkštų (0,5 ml))	Receptinis	EU/1/12/767/002	Netiekiama	-	-	No	-	-
52299	66219	1066219	flakonas	N1 (ir 0,5 ml užpildytas švirkštas, 2 adatos)	Receptinis	EU/1/12/767/003	Tiekiama	-	-	No	-	-
52300	66220	1066220	flakonas	N10 (ir 10 užpildytų švirkštų (0,5 ml), 20 adatų)	Receptinis	EU/1/12/767/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-04-20	Registruotas