Klisyri

Medicinal product

(Invented) name

Klisyri

Active substance (s)

Tirbanibulinas

Strength

10 mg/g

Pharmaceutical form

tepalas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D06BX03, tirbanibulin

Marketing authorisation holder

Almirall, S.A., Ispanija

Date of authorisation

2021-07-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Each gram of ointment contains	1 g
Tirbanibulinas	10 mg/g

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
106870	92973	1092973	paketėlis	N5		Receptinis	EU/1/21/1558/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-16	Registruotas