Mofecet

Medicinal product

(Invented) name

Mofecet

Active substance (s)

Bupivakaino hidrochloridas

Strength

5 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į povoratinklinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01BB01, Bupivacaine

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2023-03-14

Date of renewal

Documents

5152 Mofecet PL 2025 02 14.docx

5152 Pakuotės lapelis 2025 02 14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2190/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Bupivakaino hidrochloridas	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
110647	96758	1096758	ampulė	4 ml N5		Receptinis	LT/1/23/5152/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-14	Registruotas