OKEDI

Medicinal product

(Invented) name

OKEDI

Active substance (s)

Risperidonas

Strength

100 mg

Pharmaceutical form

milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

N05AX08, Risperidone

Marketing authorisation holder

Laboratorios Farmacéuticos Rovi, S.A., Ispanija

Date of authorisation

2022-02-14

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for prolonged-release suspension for injection	1 vnt.
Risperidonas	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
108165	94269	1094269	užpildytas švirkštas	milteliai, tirpiklio užpildytas švirkštas ir sausiklis, 2 adatos N1		Receptinis	EU/1/21/1621/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-14	Registruotas