Onureg

Medicinal product

(Invented) name

Onureg

Active substance (s)

Azacitidinas

Strength

300 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC07, Azacitidine

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2021-06-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Azacitidinas	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
106803	92906	1092906	lizdinė plokštelė	N7		Receptinis	EU/1/21/1556/003	Netiekiama	-	-	No	-	-
106804	92907	1092907	lizdinė plokštelė	N14		Receptinis	EU/1/21/1556/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-17	Registruotas