Ropivacaine hydrochloride Kabi

Medicinal product

(Invented) name

Active substance (s)

Ropivakaino hidrochloridas

Strength

5 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti aplink nervus, leisti į povoratinklinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

N01BB09, Ropivacaine

Marketing authorisation holder

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2022-08-08

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1575/003/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml injekcinio tirpalo yra:	1 ml
Ropivakaino hidrochloridas	5 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
109153	95259	1095259	ampulė	10 ml N1	Receptinis	LT/1/22/5004/001	Netiekiama	-	-	No	-	-
109154	95260	1095260	ampulė	10 ml N5	Receptinis	LT/1/22/5004/002	Netiekiama	-	-	No	-	-
109155	95261	1095261	ampulė	10 ml N10	Receptinis	LT/1/22/5004/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-08	Registruotas