Tresiba

Medicinal product

(Invented) name

Tresiba

Active substance (s)

Insulinas degludekas

Strength

100 V/ml

Pharmaceutical form

injekcinis tirpalas užtaise

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AE06, Insulin degludec

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2013-01-21

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

solution for injection in cartridge (Penfill)	3 ml
Insulinas degludekas	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
109025	95131	1095131	užtaisas	3 ml N5 (Penfill)		Receptinis	EU/1/12/807/007	Netiekiama	-	-	No	-	-
109026	95132	1095132	užtaisas	3 ml N10 (Penfill)		Receptinis	EU/1/12/807/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-01-21	Registruotas