IBUSIN

Medicinal product

(Invented) name

IBUSIN

Active substance (s)

Ibuprofenas/Fenilefrino hidrochloridas

Strength

200 mg/6,1 mg

Pharmaceutical form

dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AE51, Ibuprofen, combinations

Marketing authorisation holder

US Pharmacia Sp. z o.o., Lenkija

Date of authorisation

2017-12-05

Date of renewal

2022-03-07

Documents

IBUSINE tab_NP_NPS_AR_viesas protokolas.docx

4167 pakuotes lapelis_2022-03-07.docx

4167 IBUSIN PCS 2022 12 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Ibuprofenas	200 mg
Fenilefrino hidrochloridas	6,1 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
98497	84600	1084600	lizdinė plokštelė	N6		Nereceptinis	LT/1/17/4167/001	Netiekiama	-	-	No	-	-
98498	84601	1084601	lizdinė plokštelė	N12		Nereceptinis	LT/1/17/4167/002	Netiekiama	2025-09-24	2026-12-31	No	-	-	Download
98499	84602	1084602	lizdinė plokštelė	N16		Nereceptinis	LT/1/17/4167/003	Netiekiama	-	-	No	-	-
98500	84603	1084603	lizdinė plokštelė	N18		Nereceptinis	LT/1/17/4167/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-07	Perregistruotas
2017-12-05	Registruotas