Paracetamol/Ibuprofen AFT Pharmaceuticals [Paracetamol/Ibuprofen JED]

Medicinal product

(Invented) name

Active substance (s)

Paracetamolis/Ibuprofenas

Strength

10 mg/3 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

N02BE51, Paracetamol, combinations excl. psycholeptics

Marketing authorisation holder

AFT Pharmaceuticals (EUR) Limited, Airija

Date of authorisation

2020-07-15

Date of renewal

2025-01-28

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1945/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Paracetamolis	10 mg
Ibuprofenas	3 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
104736	90837	1090837	flakonas	100 ml N10		Receptinis	LT/1/20/4594/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-28	Perregistruotas
2020-07-15	Registruotas