Eladynos

Medicinal product

(Invented) name

Eladynos

Active substance (s)

Abaloparatidas

Strength

80 µg/dozėje

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)

H05AA04, abaloparatide

Marketing authorisation holder

Theramex Ireland Limited, Airija

Date of authorisation

2022-12-12

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 dozėje
Abaloparatidas	80 µg

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
110018	96127	1096127	užpildytas švirkštiklis	1,5 ml (30 dozių) N1		Receptinis	EU/1/22/1706/001	Netiekiama	-	-	No	-	-
112169	98284	1098284	užpildytas švirkštiklis	1,5 ml (30 dozių) N3		Receptinis	EU/1/22/1706/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-12	Registruotas