Pyzchiva

Medicinal product

(Invented) name

Pyzchiva

Active substance (s)

Ustekinumabas

Strength

130 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)

L04AC05, Ustekinumab

Marketing authorisation holder

Samsung Bioepis NL B.V., Nyderlandai

Date of authorisation

2024-04-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Kiekviename flakone (26 ml) koncentrato yra	26 ml
Ustekinumabas	130 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
113522	99641	1099641	flakonas	26 ml N1		Receptinis	EU/1/24/1801/003	Tiekiama	2025-06-23	2026-06-15	Yes	2025-07-01	2026-06-15
118129	104237	1104237	flakonas	26 ml N3 (3×1)		Receptinis	EU/1/24/1801/006	Netiekiama	-	-	No	-	-
118130	104238	1104238	flakonas	26 ml N3		Receptinis	EU/1/24/1801/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-19	Registruotas