Lyumjev

Medicinal product

(Invented) name

Lyumjev

Active substance (s)

Insulinas lispro

Strength

100 V/ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AB04, Insulin lispro

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2020-03-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

KwikPen solution for injection in pre-filled pen	1 ml
Insulinas lispro	100 V

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
103535	89637	1089637	užpildytas švirkštiklis	3 ml N2 (KwikPen)		Receptinis	EU/1/20/1422/007	Netiekiama	-	-	No	-	-
103536	89638	1089638	užpildytas švirkštiklis	3 ml N5 (KwikPen)		Receptinis	EU/1/20/1422/008	Tiekiama	-	-	No	-	-
103537	89639	1089639	užpildytas švirkštiklis	3 ml N10 (2x5) (KwikPen)		Receptinis	EU/1/20/1422/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-03-24	Registruotas