Aprepitant Sandoz

Medicinal product

(Invented) name

Aprepitant Sandoz

Active substance (s)

Aprepitantas+Aprepitantas

Strength

125 mg + 80 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)

A04AD12, Aprepitant

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2018-02-07

Date of renewal

2023-06-21

Documents

4191 Pakuotės lapelis 2024 04 25.docx

4191 Aprepitant Sandoz II PL 2024 04 25.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0498/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje (125 mg) yra	1 vnt.
Aprepitantas	125 mg
Kapsulėje (80 mg) yra	1 vnt.
Aprepitantas	80 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
98885	84989	1084989	lizdinė plokštelė	N1 (125 mg) + N2 (80 mg)		Receptinis	LT/1/18/4191/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-06-21	Perregistruotas
2018-02-07	Registruotas