Omlyclo

Medicinal product

(Invented) name

Omlyclo

Active substance (s)

Omalizumabas

Strength

150 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 (1 ml tirpalo) 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
118207	104315	1104315	užpildytas švirkštiklis	1 ml N1		Receptinis	EU/1/24/1817/006	Netiekiama	-	-	No	-	-
118213	104321	1104321	užpildytas švirkštiklis	1 ml N6 (6×1)		Receptinis	EU/1/24/1817/007	Netiekiama	-	-	No	-	-
118215	104323	1104323	užpildytas švirkštiklis	1 ml N10 (10×1)		Receptinis	EU/1/24/1817/008	Netiekiama	-	-	No	-	-
118216	104324	1104324	užpildytas švirkštiklis	1 ml N2 (2×1)		Receptinis	EU/1/24/1817/012	Netiekiama	-	-	No	-	-
118217	104325	1104325	užpildytas švirkštiklis	1 ml N3 (3×1)		Receptinis	EU/1/24/1817/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-16	Registruotas