Bydureon

Medicinal product

(Invented) name

Bydureon

Active substance (s)

Eksenatidas

Strength

2 mg

Pharmaceutical form

milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

A10BJ01, Exenatide

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2011-06-17

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for prolonged release suspension for injection	0.65 ml
Eksenatidas	2 mg

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
47419	61235	1061235	flakonas	N4 (+ užpildytas švirkštas + flakono jungtis + 2 injekcinės adatos)		Receptinis	EU/1/11/696/001	Netiekiama	-	-	No	-	-
47420	61236	1061236	flakonas	N12 (3x4) (+ užpildytas švirkštas + flakono jungtis + 2 injekcinės adatos) (sudėtinė)		Receptinis	EU/1/11/696/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-06-17	Registruotas