IBUGARD

Medicinal product

(Invented) name

IBUGARD

Active substance (s)

Ibuprofenas

Strength

100 mg/5 ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AE01, Ibuprofen

Marketing authorisation holder

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2014-06-13

Date of renewal

2019-03-04

Documents

3578 IBUGARD ger susp PCS PL 2024 09 09.docx

3578 Pakuotės lapelis 2024 09 09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

LV/H/0112/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

5 ml suspensijos yra	5 ml
Ibuprofenas	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
55817	69869	1069869	buteliukas	100 ml ir geriamasis švirkštas N1		Nereceptinis	LT/1/14/3578/001	Netiekiama	-	-	No	-	-
59340	73567	1073567	buteliukas	120 ml ir geriamasis švirkštas N1		Nereceptinis	LT/1/14/3578/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-03-04	Perregistruotas
2014-06-13	Registruotas