Tresiba

Medicinal product

(Invented) name

Tresiba

Active substance (s)

Insulinas degludekas

Strength

200 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)

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 pre-filled pen ((FlexTouch)	3 ml
Insulinas degludekas	200 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
57701	71820	1071820	užpildytas švirkštiklis	3 ml N1 (FlexTouch, 7 NovoFine adatos)		Receptinis	EU/1/12/807/006	Netiekiama	-	-	No	-	-
55115	69148	1069148	užpildytas švirkštiklis	3 ml N1 (FlexTouch)		Receptinis	EU/1/12/807/009	Netiekiama	-	-	No	-	-
57702	71821	1071821	užpildytas švirkštiklis	3 ml N1 (FlexTouch, 7 NovoTwist adatos)		Receptinis	EU/1/12/807/010	Netiekiama	-	-	No	-	-
55116	69149	1069149	užpildytas švirkštiklis	3 ml N2 (FlexTouch)		Receptinis	EU/1/12/807/012	Netiekiama	-	-	No	-	-
55117	69150	1069150	užpildytas švirkštiklis	3 ml N3 (FlexTouch)		Receptinis	EU/1/12/807/013	Netiekiama	-	-	No	-	-
55118	69151	1069151	užpildytas švirkštiklis	3 ml N6 (2×3) (FlexTouch)		Receptinis	EU/1/12/807/015	Netiekiama	-	-	No	-	-
99994	86102	1086102	užpildytas švirkštiklis	3 ml N5 (FlexTouch)		Receptinis	EU/1/12/807/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-01-21	Registruotas