Ondibta

Medicinal product

(Invented) name

Ondibta

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

Gan & Lee Pharmaceuticals Europe GmbH, Vokietija

Date of authorisation

2026-01-09

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 ml injekcinio tirpalo yra:	1 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
119989	106095	1106095	užpildytas švirkštiklis	3 ml (VitaClick) N1		Receptinis	EU/1/25/2000/001	Netiekiama	-	-	No	-	-
119990	106096	1106096	užpildytas švirkštiklis	3 ml (VitaClick) N5		Receptinis	EU/1/25/2000/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-09	Registruotas