EXPAREL liposomal

Medicinal product

(Invented) name

EXPAREL liposomal

Active substance (s)

Bupivakainas

Strength

266 mg/20 ml

Pharmaceutical form

pailginto atpalaidavimo injekcinė dispersija

Route (s) of administration

leisti aplink nervus, infiltracija

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01BB01, Bupivacaine

Marketing authorisation holder

Pacira Ireland Ltd. , Airija

Date of authorisation

2020-11-16

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

Prolonged-release dispersion for injection	20 ml
Bupivakainas	266 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
105306	91408	1091408	flakonas	20 ml N4		Receptinis	EU/1/20/1489/003	Netiekiama	-	-	No	-	-
105307	91409	1091409	flakonas	20 ml N10		Receptinis	EU/1/20/1489/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-11-16	Registruotas