Ropivacaine Readyfusor

Medicinal product

(Invented) name

Ropivacaine Readyfusor

Active substance (s)

Ropivakainas

Strength

10 mg/val.

Pharmaceutical form

infuzinis tirpalas įleidimo sistemoje

Route (s) of administration

leisti aplink nervus

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01BB09, Ropivacaine

Marketing authorisation holder

BioQ Pharma B.V., Nyderlandai

Date of authorisation

2018-05-08

Date of renewal

2024-05-09

Documents

4220 Ropivacaine Readyfusor RPP 2025 04 03.docx

4220 Pakuotės lapelis 2025 04 03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/4843/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Skiriant 48 val., įleidimo sistemoje tekėjimo greitis atitinka	1 ml
Ropivakainas	10 mg/val.

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
99460	85567	1085567	buteliukas	250 ml N1 (+maišelis nešiojimui)		Receptinis	LT/1/18/4220/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-09	Perregistruotas
2018-05-08	Registruotas