Sunosi

Medicinal product

(Invented) name

Sunosi

Active substance (s)

Solriamfetolas

Strength

75 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)

N06BA14, solriamfetol

Marketing authorisation holder

Atnahs Pharma Netherlands B.V., Danija

Date of authorisation

2020-01-16

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

Film-coated tablet	1 vnt.
Solriamfetolas	75 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
103204	89305	1089305	lizdinė plokštelė	N7		Receptinis	EU/1/19/1408/001	Netiekiama	-	-	No	-	-
103205	89306	1089306	lizdinė plokštelė	N28		Receptinis	EU/1/19/1408/002	Netiekiama	-	-	No	-	-
103206	89307	1089307	lizdinė plokštelė	N56		Receptinis	EU/1/19/1408/003	Netiekiama	-	-	No	-	-
103210	89311	1089311	buteliukas	N30		Receptinis	EU/1/19/1408/004	Netiekiama	-	-	No	-	-
103211	89312	1089312	buteliukas	N100		Receptinis	EU/1/19/1408/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-16	Registruotas