Nytyka

Medicinal product

(Invented) name

Nytyka

Active substance (s)

Nintedanibas

Strength

150 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EX09, nintedanib

Marketing authorisation holder

UAB Norameda, Lietuva

Date of authorisation

2024-01-05

Date of renewal

Documents

5319_5320 Nytyka PCS 2025 02 07, PL 2025 02 07_150mg.docx

5320 Pakuotės lapelis 150mg 2025 02 07.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0557/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Nintedanibas	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
112493	98613	1098613	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/24/5320/001	Netiekiama	-	-	No	-	-
112494	98614	1098614	dalomoji lizdinė plokštelė	N60×1		Receptinis	LT/1/24/5320/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-05	Registruotas