Tachyben

Medicinal product

(Invented) name

Tachyben

Active substance (s)

Urapidilis

Strength

25 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C02CA06, Urapidil

Marketing authorisation holder

EVER Neuro Pharma GmbH, Austrija

Date of authorisation

2015-04-03

Date of renewal

2018-01-24

Documents

3702_1-3 Tachyben_perr180124.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/2963/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

5 ml tirpalo yra	5 ml
Urapidilis	25 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
59476	73705	1073705	ampulė	5 ml N5		Receptinis	LT/1/15/3702/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-03-06	Išregistruotas
2018-01-24	Perregistruotas
2015-04-03	Registruotas