Ibuprofen Nutra Essential

Medicinal product

(Invented) name

Ibuprofen Nutra Essential

Active substance (s)

Ibuprofenas

Strength

400 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

NUTRA ESSENTIAL OTC S.L., Ispanija

Date of authorisation

2017-09-28

Date of renewal

2022-12-29

Documents

4134 Ibuprofen Nutra Essential 400 Rp PCS PL 2025 02 07.docx

4134 Pakuotės lapelis 400mg Rp 2025 02 07.docx

4134 Ibuprofen Nutra Essential 400 OTC PCS PL 2025 02 07.docx

4134 Pakuotės lapelis 400mg OTC 2025 02 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SI/H/0214/003

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename vienadoziame paketėlyje (10 ml suspensijos) yra	10 ml
Ibuprofenas	400 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
97924	84020	1084020	paketėlis	10 ml N10		Nereceptinis	LT/1/17/4134/006	Netiekiama	-	-	No	-	-
97925	84021	1084021	paketėlis	10 ml N12		Nereceptinis	LT/1/17/4134/007	Netiekiama	-	-	No	-	-
97926	84022	1084022	paketėlis	10 ml N30		Receptinis	LT/1/17/4134/008	Netiekiama	-	-	No	-	-
107034	93137	1093137	paketėlis	10 ml N24		Receptinis	LT/1/17/4134/009	Netiekiama	-	-	No	-	-
115944	102046	1102046	paketėlis	10 ml N20		Nereceptinis	LT/1/17/4134/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Perregistruotas
2017-09-28	Registruotas