Brufen

Medicinal product

(Invented) name

Brufen

Active substance (s)

Ibuprofenas

Strength

200 mg

Pharmaceutical form

šnypščiosios granulės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AE01, Ibuprofen

Marketing authorisation holder

Mylan IRE Healthcare Limited, Airija

Date of authorisation

2013-03-18

Date of renewal

2018-11-29

Documents

3252_2_3 Brufen 200mg snypsc gran Rp PCS PL 201111.docx

3252_1 Brufen 200mg snypsc gran OTC PCS PL 201111.docx

3252_2_3 Pakuotės lapelis 201111.docx

3252_1 Pakuotės lapelis 201111.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

EE/H/0295/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename paketėlyje yra	1 vnt.
Ibuprofenas	200 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
47991	61814	1061814	paketėlis	N12		Nereceptinis	LT/1/13/3252/001	Netiekiama	-	-	No	-	-
55499	69547	1069547	paketėlis	N20		Receptinis	LT/1/13/3252/002	Netiekiama	-	-	No	-	-
55500	69548	1069548	paketėlis	N30		Receptinis	LT/1/13/3252/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-30	Išregistruotas
2018-11-29	Perregistruotas
2013-03-18	Registruotas