Paliperidone Teva

Medicinal product

(Invented) name

Paliperidone Teva

Active substance (s)

Paliperidonas

Strength

50 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

Teva GmbH, Vokietija

Date of authorisation

2021-10-08

Date of renewal

2024-02-28

Documents

4817_4820 Paliperidone Teva PCS PL 2024 02 28, KR_3682.docx

4817_4820 Pakuotės lapelis 2024 02 28, KR_3682.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/5542/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Užpildytame švirkšte yra	1 vnt.
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
107314	93419	1093419	užpildytas švirkštas	užpildytas švirkštas ir 2 adatos N1		Receptinis	LT/1/21/4817/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-28	Perregistruotas
2021-10-08	Registruotas