Kudorp

Medicinal product

(Invented) name

Kudorp

Active substance (s)

Fenspiridas

Strength

2 mg/ml

Pharmaceutical form

sirupas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03DX03, Fenspiride

Marketing authorisation holder

Medana Pharma SA, Lenkija

Date of authorisation

2015-05-26

Date of renewal

Documents

3728_1 Pakuotės lapelis 180912.docx

3728_1 Kudorp sirupas PZ PL 180912.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PL/H/0302/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml sirupo yra	1 ml
Fenspiridas	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
56316	70413	1070413	buteliukas	150 ml ir matavimo šaukštas arba geriamasis švirkštas N1		Receptinis	LT/1/15/3728/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-06-07	Išregistruotas
2019-02-14	Sustabdytas
2015-05-26	Registruotas