Ibuprofen Actavis

Medicinal product

(Invented) name

Ibuprofen Actavis

Active substance (s)

Ibuprofenas

Strength

50 mg

Pharmaceutical form

geriamoji suspensija paketėlyje

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2017-12-27

Date of renewal

Documents

4177_2-3&5-6&8-9&11-13 Ibuprofen_ActavisRp_DC.docx

4177_1&4&7&10 Ibuprofen_ActavisOTC_DC.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

UK/H/6280/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Paketėlyje (2,5 ml) yra	2.5 ml
Ibuprofenas	50 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
98601	84705	1084705	paketėlis	2,5 ml N10		Nereceptinis	LT/1/17/4177/001	Netiekiama	-	-	No	-	-
98602	84706	1084706	paketėlis	2,5 ml N20		Receptinis	LT/1/17/4177/002	Netiekiama	-	-	No	-	-
98603	84707	1084707	paketėlis	2,5 ml N30		Receptinis	LT/1/17/4177/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-03	Išregistruotas
2017-12-27	Registruotas