EXPAREL liposomal

Medicinal product

(Invented) name

EXPAREL liposomal

Active substance (s)

Bupivakainas

Strength

133 mg/10 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	10 ml
Bupivakainas	133 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
105304	91406	1091406	flakonas	10 ml N4		Receptinis	EU/1/20/1489/001	Netiekiama	-	-	No	-	-
105305	91407	1091407	flakonas	10 ml N10		Receptinis	EU/1/20/1489/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-11-16	Registruotas