Niapelf

Medicinal product

(Invented) name

Niapelf

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

Neuraxpharm Pharmaceuticals, S.L., Ispanija

Date of authorisation

2024-03-21

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Prolonged-release suspension for injection (I)	1.5 ml
Paliperidonas	150 mg
Prolonged-release suspension for injection (VIII)	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
113271	99390	1099390	užpildytas švirkštas	N2 (150 mg + 2 adatos) + (100 mg + 2 adatos)	pakuotė gydymui pradėti	Receptinis	EU/1/24/1795/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-03-21	Registruotas