Winrevair

Medicinal product

(Invented) name

Winrevair

Active substance (s)

Sotaterceptas

Strength

45 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C02KX06, sotatercept

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2024-08-22

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

Flakone yra:	1 vnt.
Sotaterceptas	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
114850	100955	1100955	flakonas	milteliai, tirpiklio užpildytas švirkštas, flakono adapteris, dozavimo švirkštas, adata, 4 alkoholiu suvilgyti tamponai N2		Receptinis	EU/1/24/1850//002	Netiekiama	-	-	No	-	-
114849	100954	1100954	flakonas	milteliai, tirpiklio užpildytas švirkštas, flakono adapteris, dozavimo švirkštas, adata, 4 alkoholiu suvilgyti tamponai N1		Receptinis	EU/1/24/1850/001	Tiekiama	2025-04-24	-	No	-	-

Stadijos

Data	Stadija
2024-08-22	Registruotas