Sogroya

Medicinal product

(Invented) name

Sogroya

Active substance (s)

Somapacitanas

Strength

10 mg/1,5 ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01AC07, somapacitan

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2021-03-31

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

Solution for injection in pre-filled pen	1.5 ml
Somapacitanas	10 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
106300	92401	1092401	užpildytas švirkštiklis	1,5 ml N1		Receptinis	EU/1/20/1501/001	Netiekiama	-	-	No	-	-
106301	92402	1092402	užpildytas švirkštiklis	1,5 ml N5 (5x1)		Receptinis	EU/1/20/1501/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-31	Registruotas