Abfen

Medicinal product

(Invented) name

Abfen

Active substance (s)

Ibuprofenas

Strength

40 mg/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

Viatris Healthcare Limited, Airija

Date of authorisation

2014-04-28

Date of renewal

2017-06-13

Documents

3546 Abfen PCS PL 2024 02 28.docx

3546 Pakuotės lapelis 2024 02 28.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PT/H/2354/001

Marketing authorisation procedure

Kartotinė 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
54818	68832	1068832	buteliukas	30 ml ir geriamasis švirkštas N1		Nereceptinis	LT/1/14/3546/001	Netiekiama	-	-	No	-	-
58963	73183	1073183	buteliukas	100 ml ir geriamasis švirkštas N1		Nereceptinis	LT/1/14/3546/002	Netiekiama	-	-	No	-	-
58964	73184	1073184	buteliukas	150 ml ir geriamasis švirkštas N1		Nereceptinis	LT/1/14/3546/003	Netiekiama	-	-	No	-	-
58965	73185	1073185	buteliukas	200 ml ir geriamasis švirkštas N1		Nereceptinis	LT/1/14/3546/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-27	Išregistruotas
2017-06-13	Perregistruotas
2014-04-28	Registruotas