Ibuprom

Medicinal product

(Invented) name

Ibuprom

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

US Pharmacia Sp. z o.o., Lenkija

Date of authorisation

2015-02-17

Date of renewal

2019-06-20

Documents

LT_180_1_PAR SD+Summ+LT apzvalga.pdf

3682 Ibuprom 40mg_ml PCS PL 2024 12 12.docx

3682 Pakuotės lapelis 2024 12 12.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0180/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml geriamosios 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
59052	73273	1073273	buteliukas	30 ml ir geriamasis švirkštas (5 ml) N1		Nereceptinis	LT/1/15/3682/001	Netiekiama	-	-	No	-	-
61332	75650	1075650	buteliukas	100 ml ir geriamasis švirkštas (5 ml) N1		Nereceptinis	LT/1/15/3682/002	Tiekiama	-	-	No	-	-	Download
61333	75651	1075651	buteliukas	150 ml ir geriamasis švirkštas (5 ml) N1		Nereceptinis	LT/1/15/3682/003	Netiekiama	-	-	No	-	-
61334	75652	1075652	buteliukas	200 ml ir geriamasis švirkštas (5 ml) N1		Nereceptinis	LT/1/15/3682/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-06-20	Perregistruotas
2015-02-17	Registruotas