Ibustar

Medicinal product

(Invented) name

Ibustar

Active substance (s)

Ibuprofenas

Strength

40 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Purpose for use

vaikams

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AE01, Ibuprofen

Marketing authorisation holder

Berlin-Chemie AG, Vokietija

Date of authorisation

2015-11-03

Date of renewal

2016-11-10

Documents

3829 Ibustar 40mg_ml PCS PL 2025 02 27.docx

3829 Pakuotės lapelis 2025 02 27.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/2598/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml suspensijos yra	1 ml
Ibuprofenas	40 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
61276	75592	1075592	buteliukas	30 ml ir geriamasis švirkštas (5 ml) N1		Nereceptinis	LT/1/15/3829/001	Netiekiama	-	-	No	-	-
64136	78583	1078583	buteliukas	100 ml ir geriamasis švirkštas (5 ml) N1		Nereceptinis	LT/1/15/3829/002	Tiekiama	-	-	No	-	-	Download
64137	78584	1078584	buteliukas	150 ml ir geriamasis švirkštas (5 ml) N1		Nereceptinis	LT/1/15/3829/003	Netiekiama	-	-	No	-	-
64138	78585	1078585	buteliukas	200 ml ir geriamasis švirkštas (5 ml) N1		Nereceptinis	LT/1/15/3829/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-10	Perregistruotas
2015-11-03	Registruotas