Cessolute

Medicinal product

(Invented) name

Cessolute

Active substance (s)

Lidokainas/Tetrakainas

Strength

70 mg/70 mg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N01BB52, Lidocaine, combinations

Marketing authorisation holder

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2023-12-22

Date of renewal

Documents

5306_pakuotes lapelis_2023-12-22.docx

5306_Cessolute.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

HU/H/0844/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g kremo yra:	1 g
Lidokainas	70 mg
Tetrakainas	70 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
112384	98499	1098499	tūbelė	15 g N1		Receptinis	LT/1/23/5306/001	Netiekiama	-	-	No	-	-
112385	98500	1098500	tūbelė	30 g N1		Receptinis	LT/1/23/5306/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-22	Registruotas