ESMOCARD

Medicinal product

(Invented) name

ESMOCARD

Active substance (s)

Esmololis

Strength

100 mg/10 ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C07AB09, Esmolol

Marketing authorisation holder

OrPha-Devel Handels und Vertriebs GmbH, Austrija

Date of authorisation

2007-07-03

Date of renewal

2011-06-27

Documents

0714_1 Pakuotės lapelis 190123.docx

0714_1 ESMOCARD inj II PL 190123.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/0779/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Buteliuke (10 ml) yra	10 ml
Esmololis	100 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
20272	23314	1023314	buteliukas	10 ml N5		Receptinis	LT/1/07/0714/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-05	Išregistruotas
2011-06-27	Perregistruotas
2007-07-03	Registruotas