Omlyclo

Medicinal product

(Invented) name

Omlyclo

Active substance (s)

Omalizumabas

Strength

150 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

Kiekviename tirpalo užpildytame švirkšte (1 ml) yra	1 ml
Omalizumabas	150 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
113750	99867	1099867	užpildytas švirkštas	1 ml N1 (su adatos apsauga)		Receptinis	EU/1/24/1817/002	Netiekiama	-	-	No	-	-
113751	99868	1099868	užpildytas švirkštas	1 ml N6 (6×1) (su adatos apsauga)		Receptinis	EU/1/24/1817/003	Netiekiama	-	-	No	-	-
113752	99869	1099869	užpildytas švirkštas	1 ml N10 (10×1) (su adatos apsauga)		Receptinis	EU/1/24/1817/004	Netiekiama	-	-	No	-	-
118214	104322	1104322	užpildytas švirkštas	1 ml N3 (3×1) (su adatos apsauga)		Receptinis	EU/1/24/1817/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-16	Registruotas