Ropivacaine B.Braun

Medicinal product

(Invented) name

Ropivacaine B.Braun

Active substance (s)

Ropivakainas

Strength

7,5 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į epidurinę ertmę, leisti aplink nervus

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01BB09, Ropivacaine

Marketing authorisation holder

B.Braun Melsungen AG, Vokietija

Date of authorisation

2011-10-25

Date of renewal

2013-11-08

Documents

2680 Ropivacaine B_Braun 7,5mg_ml PCS PL 2023 10 26.docx

2680 Pakuotės lapelis 7,5mg_ml 2023 10 26.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/2536/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Ropivakainas	7,5 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
36136	38468	1038468	ampulė	10 ml N20		Receptinis	LT/1/11/2680/003	Tiekiama	-	-	No	-	-	Download
36137	38469	1038469	ampulė	20 ml N20		Receptinis	LT/1/11/2680/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-11-08	Perregistruotas
2011-10-25	Registruotas