Rispolept

Medicinal product

(Invented) name

Rispolept

Active substance (s)

Risperidonas

Strength

1 mg/ml

Pharmaceutical form

geriamasis tirpalas

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

UAB Johnson & Johnson, Lietuva

Date of authorisation

1998-10-22

Date of renewal

2017-11-13

Documents

0215 Rispolept ger tirp II PL 2025 04 30.docx

0215 Pakuotės lapelis 2025 04 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/2184/008

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml geriamojo tirpalo yra	1 ml
Risperidonas	1 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
9834	2733	1002733	buteliukas	100 ml ir dozavimo pipetė N1		Receptinis	LT/1/98/0215/001	Tiekiama	-	-	No	-	-	Download
49285	63154	1063154	buteliukas	30 ml ir dozavimo pipetė N1		Receptinis	LT/1/98/0215/006	Netiekiama	-	-	No	-	-
49286	63155	1063155	buteliukas	60 ml ir dozavimo pipetė N1		Receptinis	LT/1/98/0215/007	Netiekiama	-	-	No	-	-
49287	63156	1063156	buteliukas	120 ml ir dozavimo pipetė N1		Receptinis	LT/1/98/0215/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-13	Perregistruotas
1998-10-22	Registruotas