Orladeyo

Medicinal product

(Invented) name

Orladeyo

Active substance (s)

Berotralstatas

Strength

150 mg

Pharmaceutical form

kietosios kapsulės

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

Capsule, hard	1 vnt.
Berotralstatas	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
106501	92602	1092602	lizdinė plokštelė	N28		Receptinis	EU/1/21/1544/001	Netiekiama	-	-	No	-	-
106502	92603	1092603	lizdinė plokštelė	N98		Receptinis	EU/1/21/1544/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-30	Registruotas