Oxbryta

Medicinal product

(Invented) name

Oxbryta

Active substance (s)

Vokselotoras

Strength

500 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)

B06AX03, voxelotor

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2022-02-14

Date of renewal

Documents

Search in EMA Europe

Stage

Sustabdytas

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.
Vokselotoras	500 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
108163	94267	1094267	buteliukas	N90		Receptinis	EU/1/21/1622/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-26	Sustabdytas
2022-02-14	Registruotas