Omlyclo

Medicinal product

(Invented) name

Omlyclo

Active substance (s)

Omalizumabas

Strength

300 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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 švirkšte (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
119119	105224	1105224	užpildytas švirkštas	2 ml N1 (su adatos apsauga)		Receptinis	EU/1/24/1817/014	Netiekiama	-	-	No	-	-
119120	105225	1105225	užpildytas švirkštas	2 ml N2 (2×1) (su adatos apsauga)		Receptinis	EU/1/24/1817/015	Netiekiama	-	-	No	-	-
119121	105226	1105226	užpildytas švirkštas	2 ml N3 (3×1) (su adatos apsauga)		Receptinis	EU/1/24/1817/016	Netiekiama	-	-	No	-	-
119122	105227	1105227	užpildytas švirkštas	2 ml N6 (6×1) (su adatos apsauga)		Receptinis	EU/1/24/1817/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-16	Registruotas