Paliperidone Sandoz

Medicinal product

(Invented) name

Paliperidone Sandoz

Active substance (s)

Paliperidonas

Strength

50 mg

Pharmaceutical form

pailginto atpalaidavimo injekcinė suspensija užpildytame švirkšte

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

N05AX13, Paliperidone

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2025-08-21

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2387/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Užpildytame švirkšte (0,5 ml tirpalo) yra	0.5 ml
Paliperidonas	50 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
118387	104493	1104493	užpildytas švirkštas	N1 ir 2 adatos		Receptinis	LT/1/25/5830/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-21	Registruotas