Bydureon

Medicinal product

(Invented) name

Bydureon

Active substance (s)

Eksenatidas

Strength

2 mg

Pharmaceutical form

pailginto atpalaidavimo injekcinė suspensija užpildytame švirkštiklyje

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

Prolonged-release suspension for injection in pre-filled pen	0.85 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
100276	86385	1086385	užpildytas švirkštiklis	N4 (BCise)		Receptinis	EU/1/11/696/005	Netiekiama	-	-	No	-	-
102287	88387	1088387	užpildytas švirkštiklis	N12 (3x4) (BCise)		Receptinis	EU/1/11/696/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-06-17	Registruotas