Paliperidone Janssen

Medicinal product

(Invented) name

Paliperidone Janssen

Active substance (s)

Paliperidonas+Paliperidonas

Strength

150 mg + 100 mg

Pharmaceutical form

pailginto atpalaidavimo injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AX13, Paliperidone

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2014-12-05

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Prolonged release suspension for injection (150 mg)	2.25 ml
Paliperidonas	150 mg
Prolonged release suspension for injection (100 mg)	1 ml
Paliperidonas	100 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
60922	75229	1075229	užpildytas švirkštas	N1 (150 mg+100 mg) +2 adatos		Receptinis	EU/1/14/971/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2014-12-05	Registruotas