Risperidone Grindeks

Medicinal product

(Invented) name

Risperidone Grindeks

Active substance (s)

Risperidonas

Strength

6 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AX08, Risperidone

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2023-07-31

Date of renewal

Documents

5214_5219 Risperidone Grindeks PL 2024 11 04, VRA.docx

5214_5219 Pakuotės lapelis 2024 11 04, VRA.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1148/006/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Risperidonas	6 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
111411	97524	1097524	lizdinė plokštelė	N20		Receptinis	LT/1/23/5219/001	Netiekiama	-	-	No	-	-
111412	97525	1097525	lizdinė plokštelė	N30		Receptinis	LT/1/23/5219/002	Netiekiama	-	-	No	-	-
111413	97526	1097526	lizdinė plokštelė	N60		Receptinis	LT/1/23/5219/003	Netiekiama	-	-	No	-	-
111414	97527	1097527	lizdinė plokštelė	N100		Receptinis	LT/1/23/5219/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-31	Registruotas