Paracetamol/Ibuprofen Vale

Medicinal product

(Invented) name

Paracetamol/Ibuprofen Vale

Active substance (s)

Paracetamolis/Ibuprofenas

Strength

500 mg/200 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02BE51, Paracetamol, combinations excl. psycholeptics

Marketing authorisation holder

Vale Pharmaceuticals Limited, Airija

Date of authorisation

Date of renewal

Documents

5878_pakuotes lapelis_2025-10-31_Nerp.docx

5878_Paracetamol_Ibuprofen Vale_Rp.docx

5878_pakuotes lapelis_2025-10-31_Rp.docx

5878_Paracetamol_Ibuprofen Vale_Nerp.docx

Stage

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/1372/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Paracetamolis	500 mg
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
119011	105117	1105117	lizdinė plokštelė	N10		Nereceptinis	LT/1/25/5878/001	Netiekiama	-	-	No	-	-
119012	105118	1105118	lizdinė plokštelė	N20		Nereceptinis	LT/1/25/5878/002	Netiekiama	-	-	No	-	-
119013	105119	1105119	lizdinė plokštelė	N30		Receptinis	LT/1/25/5878/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija