Tropex

Medicinal product

(Invented) name

Tropex

Active substance (s)

Fenazonas

Strength

50 mg/ml

Pharmaceutical form

ausų lašai (tirpalas)

Route (s) of administration

vartoti į ausis

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02BB01, Phenazone

Marketing authorisation holder

Rowa Pharmaceuticals Ltd., Airija

Date of authorisation

2000-12-07

Date of renewal

2009-10-14

Documents

1737 PAKUOTĖS LAPELIS 2025 03 17, VRA rastas 5079.docx

1737 Tropex PL 2025 03 17, VRA rastas 5079.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Fenazonas	50 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
8528	13240	1013240	buteliukas	10 ml N1		Nereceptinis	LT/1/2000/1737/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2009-10-14	Perregistruotas
2000-12-07	Registruotas