Orladeyo

Medicinal product

(Invented) name

Orladeyo

Active substance (s)

Berotralstatas

Strength

108 mg

Pharmaceutical form

plėvele dengtos granulės paketėlyje

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B06AC06, Berotralstat

Marketing authorisation holder

BioCryst Ireland Limited, Airija

Date of authorisation

2021-03-30

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

Paketėlyje yra	1 vnt.
Berotralstatas	108 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
122174	108285	1108285	paketėlis	N28 (4×7)		Receptinis	EU/1/21/1544/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-30	Registruotas