Sogroya

Medicinal product

(Invented) name

Sogroya

Active substance (s)

Somapacitanas

Strength

5 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

2021-03-24

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	5 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
108551	94655	1094655	užpildytas švirkštiklis	1,5 ml N1		Receptinis	EU/1/20/1501/003	Netiekiama	-	-	No	-	-
108552	94656	1094656	užpildytas švirkštiklis	1,5 ml N5 (5×1)		Receptinis	EU/1/20/1501/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-24	Registruotas