Ropivacaine hydrochloride Kabi

Medicinal product

(Invented) name

Ropivacaine hydrochloride Kabi

Active substance (s)

Ropivakaino hidrochloridas

Strength

2 mg/ml

Pharmaceutical form

infuzinis 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

5003 Pakuotės lapelis 2024 11 08.docx

5003 Ropivacaine HCl Kabi infuz PCS PL 2024 11 08.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1575/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml infuzinio tirpalo yra:	1 ml
Ropivakaino hidrochloridas	2 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
109148	95254	1095254	maišelis	100 ml N1		Receptinis	LT/1/22/5003/001	Netiekiama	-	-	No	-	-
109149	95255	1095255	maišelis	100 ml N5		Receptinis	LT/1/22/5003/002	Netiekiama	-	-	No	-	-
109150	95256	1095256	maišelis	100 ml N10		Receptinis	LT/1/22/5003/003	Netiekiama	-	-	No	-	-
109151	95257	1095257	maišelis	200 ml N1		Receptinis	LT/1/22/5003/004	Netiekiama	-	-	No	-	-
109152	95258	1095258	maišelis	200 ml N5		Receptinis	LT/1/22/5003/005	Netiekiama	-	-	No	-	-
109222	95328	1095328	maišelis	200 ml N10		Receptinis	LT/1/22/5003/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-08	Registruotas