Sunosi

Medicinal product

(Invented) name

Sunosi

Active substance (s)

Solriamfetolas

Strength

150 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	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
103207	89308	1089308	lizdinė plokštelė	N7		Receptinis	EU/1/19/1408/006	Netiekiama	-	-	No	-	-
103208	89309	1089309	lizdinė plokštelė	N28		Receptinis	EU/1/19/1408/007	Netiekiama	-	-	No	-	-
103209	89310	1089310	lizdinė plokštelė	N56		Receptinis	EU/1/19/1408/008	Netiekiama	-	-	No	-	-
103212	89313	1089313	buteliukas	N30		Receptinis	EU/1/19/1408/009	Netiekiama	-	-	No	-	-
103213	89314	1089314	buteliukas	N100		Receptinis	EU/1/19/1408/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-16	Registruotas