Skytrofa [Lonapegsomatropin Ascendis Pharma]

Medicinal product

(Invented) name

Active substance (s)

Lonapegsomatropinas

Strength

9,1 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui užtaise

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

H01AC09, lonapegsomatropin

Marketing authorisation holder

Ascendis Pharma Endocrinology Division A/S, Danija

Date of authorisation

2022-01-11

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection in cartridge	1 vnt.
Lonapegsomatropinas	9,1 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
107940	94045	1094045	užtaisas	N4 (6 adatos)		Receptinis	EU/1/21/1607/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-11	Registruotas