Ropivacaine hydrochloride Kabi

Medicinal product

(Invented) name

Ropivacaine hydrochloride Kabi

Active substance (s)

Ropivakaino hidrochloridas

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

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

Date of authorisation

2022-08-08

Date of renewal

Documents

5002,5005,5006 Pakuotės lapelis 2024 11 08.docx

5002,5005,5006 Ropivacaine HCl Kabi 2_7,5_10 PCS PL 2024 11 08.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1575/004/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml injekcinio tirpalo yra:	1 ml
Ropivakaino hidrochloridas	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
109162	95268	1095268	ampulė	10 ml N1		Receptinis	LT/1/22/5005/001	Netiekiama	-	-	No	-	-
109163	95269	1095269	ampulė	10 ml N5		Receptinis	LT/1/22/5005/002	Tiekiama	2025-01-23	-	No	-	-
109164	95270	1095270	ampulė	10 ml N10		Receptinis	LT/1/22/5005/003	Netiekiama	-	-	No	-	-
109165	95271	1095271	ampulė	20 ml N1		Receptinis	LT/1/22/5005/004	Netiekiama	-	-	No	-	-
109166	95272	1095272	ampulė	20 ml N5		Receptinis	LT/1/22/5005/005	Netiekiama	-	-	No	-	-
109167	95273	1095273	ampulė	20 ml N10		Receptinis	LT/1/22/5005/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-08	Registruotas