Lusduna

Medicinal product

(Invented) name

Lusduna

Active substance (s)

Insulinas glarginas

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)

A10AE04, Insulin glargine

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2017-01-04

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled pen	3 ml
Insulinas glarginas	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
67425	81977	1081977	užpildytas švirkštiklis	3 ml N1		Receptinis	EU/1/16/1162/001	Netiekiama	-	-	No	-	-
67426	81978	1081978	užpildytas švirkštiklis	3 ml N5		Receptinis	EU/1/16/1162/002	Netiekiama	-	-	No	-	-
67427	81979	1081979	užpildytas švirkštiklis	3 ml N10 (2x5x3 ml) (dauginė)		Receptinis	EU/1/16/1162/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-10-31	Išregistruotas
2017-01-04	Registruotas