Pyrukynd

Medicinal product

(Invented) name

Pyrukynd

Active substance (s)

Mitapivatas+Mitapivatas

Strength

5 mg + 20 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)

B06AX04, mitapivatas

Marketing authorisation holder

Agios Netherlands B.V., Nyderlandai

Date of authorisation

2022-11-09

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

Tabletėje (5 mg) yra:	1 vnt.
Mitapivatas	5 mg
Tabletėje (20 mg) yra:	1 vnt.
Mitapivatas	20 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
109936	96043	1096043	lizdinė plokštelė	palaipsnio dozės mažinimo pakuotė N14 (7×5 mg + 7×20 mg)		Receptinis	EU/1/22/1662/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-11-09	Registruotas