Sunlenca

Medicinal product

(Invented) name

Sunlenca

Active substance (s)

Lenakapaviras

Strength

463,5 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AX31, lenacapavir

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2022-08-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1.5 ml
Lenakapaviras	463,5 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
109258	95364	1095364	flakonas	N2 (flakono jungties prietaisas, švirkštas, injekcinė adata)		Receptinis	EU/1/22/1671/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-17	Registruotas