Omlyclo

Medicinal product

(Invented) name

Omlyclo

Active substance (s)

Omalizumabas

Strength

300 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03DX05, Omalizumab

Marketing authorisation holder

Celltrion Healthcare Hungary Kft., Vengrija

Date of authorisation

2024-05-16

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

Užpildytame švirkštiklyje (2 ml tirpalo) yra	2 ml
Omalizumabas	300 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
120881	106989	1106989	užpildytas švirkštiklis	N1		Receptinis	EU/1/24/1817/018	Netiekiama	-	-	No	-	-
120882	106990	1106990	užpildytas švirkštiklis	N2 (2×1)		Receptinis	EU/1/24/1817/019	Netiekiama	-	-	No	-	-
120883	106991	1106991	užpildytas švirkštiklis	N3 (3×1)		Receptinis	EU/1/24/1817/020	Netiekiama	-	-	No	-	-
120884	106992	1106992	užpildytas švirkštiklis	N6 (6×1)		Receptinis	EU/1/24/1817/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-16	Registruotas