LIBTAYO

Medicinal product

(Invented) name

LIBTAYO

Active substance (s)

Cemiplimabas

Strength

350 mg

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FF06, cemiplimab

Marketing authorisation holder

Regeneron Ireland Designated Activity Company (DAC), Airija

Date of authorisation

2019-06-28

Date of renewal

Documents

LIBTAYO mokomoji medziaga pacientams.pdf

LIBTAYO paciento kortele.pdf

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

Concentrate for solution for infusion	7 ml
Cemiplimabas	350 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
102026	88128	1088128	flakonas	7 ml N1		Receptinis	EU/1/19/1376/001	Netiekiama	2024-04-18	2025-12-31	Yes	2024-11-07	2025-12-31

Stadijos

Data	Stadija
2019-06-28	Registruotas