Pemazyre

Medicinal product

(Invented) name

Pemazyre

Active substance (s)

Pemigatinibas

Strength

13,5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EN02, pemigatinib

Marketing authorisation holder

Incyte Biosciences Distribution B.V., Nyderlandai

Date of authorisation

2021-03-26

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

Tablet	1 vnt.
Pemigatinibas	13,5 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
106216	92317	1092317	lizdinė plokštelė	N14		Receptinis	EU/1/21/1535/005	Netiekiama	-	-	No	-	-
106217	92318	1092318	lizdinė plokštelė	N28		Receptinis	EU/1/21/1535/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas