Paliperidone Teva

Medicinal product

(Invented) name

Paliperidone Teva

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

Teva B.V., Nyderlandai

Date of authorisation

2021-10-08

Date of renewal

Documents

4817_4718_4719_4720_4721_Paliperidone Teva.docx

4817-4721_pakuotes lapelis_2021-10-08.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/5542/005-004/E/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Užpildytame švirkšte yra:	1 vnt.
Paliperidonas	150 mg
Užpildytame švirkšte yra:	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
107313	93418	1093418	užpildytas švirkštas	užpildytas švirkštas ir 2 adatos N1 (150 mg+100 mg)		Receptinis	LT/1/21/4821/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-28	Išregistruotas
2021-10-08	Registruotas