Lyfnua

Medicinal product

(Invented) name

Lyfnua

Active substance (s)

Gefapiksantas

Strength

45 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05DB29, gefapixant

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2023-09-15

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

Film-coated tablet	1 vnt.
Gefapiksantas	45 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
111679	97792	1097792	lizdinė plokštelė	N28		Receptinis	EU/1/21/1613/001	Netiekiama	-	-	No	-	-
111680	97793	1097793	lizdinė plokštelė	N56		Receptinis	EU/1/21/1613/002	Netiekiama	-	-	No	-	-
111681	97794	1097794	lizdinė plokštelė	N98		Receptinis	EU/1/21/1613/003	Netiekiama	-	-	No	-	-
111682	97795	1097795	lizdinė plokštelė	N196 (2×98)		Receptinis	EU/1/21/1613/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-15	Registruotas