Irexime

Medicinal product

(Invented) name

Irexime

Active substance (s)

Klindamicinas/Benzoilo peroksidas

Strength

10 mg/50 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D10AF51, Clindamycin, combinations

Marketing authorisation holder

Orifarm Healthcare A/S, Danija

Date of authorisation

2023-11-22

Date of renewal

Documents

5275 Pakuotės lapelis 2024 06 14.docx

5275 Irexime II PL 2024 06 14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

FI/H/1387/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 g gelio yra:	1 g
Klindamicinas	10 mg
Benzoilo peroksidas	50 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
112087	98202	1098202	tūbelė	25 g N1		Receptinis	LT/1/23/5275/001	Netiekiama	-	-	No	-	-
112088	98203	1098203	tūbelė	30 g N1		Receptinis	LT/1/23/5275/002	Netiekiama	-	-	No	-	-	Download
112089	98204	1098204	tūbelė	50 g N1		Receptinis	LT/1/23/5275/003	Netiekiama	-	-	No	-	-
112090	98205	1098205	tūbelė	60 g N1		Receptinis	LT/1/23/5275/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-22	Registruotas