Dioppex

Medicinal product

(Invented) name

Dioppex

Active substance (s)

Paracetamolis/Fenilefrino hidrochloridas

Strength

1000 mg/12,2 mg

Pharmaceutical form

milteliai geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02BE51, Paracetamol, combinations excl. psycholeptics

Marketing authorisation holder

WICK Pharma, Vokietija

Date of authorisation

2014-10-27

Date of renewal

2018-09-27

Documents

3645 Dioppex II PL 2022 11 25.docx

3645 Pakuotės lapelis 2022 11 25.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0618/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kiekviename paketėlyje yra:	1 vnt.
Paracetamolis	1000 mg
Fenilefrino hidrochloridas	12,2 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
59006	73227	1073227	paketėlis	N5		Nereceptinis	LT/1/14/3645/001	Netiekiama	-	-	No	-	-	Download
60443	74721	1074721	paketėlis	N10		Nereceptinis	LT/1/14/3645/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-27	Perregistruotas
2014-10-27	Registruotas