Xeplion

Medicinal product

(Invented) name

Xeplion

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

2011-03-04

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

Prolonged release suspension for injection (150 mg)	1 vnt.
Paliperidonas	150 mg
Prolonged release suspension for injection (100 mg)	1 vnt.
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
45754	59556	1059556	užpildytas švirkštas	pakuotė gydymui pradėti: (150 mg) ir 2 adatos N1 + (100 mg) ir 2 adatos N1		Receptinis	EU/1/11/672/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-03-04	Registruotas