Tresiba

Medicinal product

(Invented) name

Tresiba

Active substance (s)

Insulinas degludekas

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)

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	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
55110	69143	1069143	užpildytas švirkštiklis	3 ml N1 (FlexTouch)		Receptinis	EU/1/12/807/001	Netiekiama	-	-	No	-	-
57699	71818	1071818	užpildytas švirkštiklis	3 ml N1 ((FlexTouch, 7 NovoFine adatos)		Receptinis	EU/1/12/807/002	Netiekiama	-	-	No	-	-
57700	71819	1071819	užpildytas švirkštiklis	3 ml N1 (FlexTouch, 7 NovoTwist adatos)		Receptinis	EU/1/12/807/003	Netiekiama	-	-	No	-	-
55111	69144	1069144	užpildytas švirkštiklis	3 ml N5 (FlexTouch)		Receptinis	EU/1/12/807/004	Tiekiama	-	-	No	-	-
55112	69145	1069145	užpildytas švirkštiklis	3 ml N10 (2x5) (FlexTouch)		Receptinis	EU/1/12/807/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-01-21	Registruotas