Combogesic

Medicinal product

(Invented) name

Combogesic

Active substance (s)

Paracetamolis/Ibuprofenas

Strength

32 mg/9,6 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02BE51, Paracetamol, combinations excl. psycholeptics

Marketing authorisation holder

Swixx Biopharma Kft., Vengrija

Date of authorisation

2023-07-26

Date of renewal

Documents

5212 Combogesic PCS PL 2025 02 14.docx

5212 Pakuotės lapelis 2025 02 14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

MT/H/0610/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml suspensijos yra:	1 ml
Paracetamolis	32 mg
Ibuprofenas	9,6 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
111327	97440	1097440	buteliukas	100 ml N1 (+ 5 ml matavimo švirkštas)		Receptinis	LT/1/23/5212/001	Netiekiama	-	-	No	-	-
111328	97441	1097441	buteliukas	200 ml N1 (+ 5 ml matavimo švirkštas)		Receptinis	LT/1/23/5212/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-26	Registruotas