Sondelbay

Medicinal product

(Invented) name

Sondelbay

Active substance (s)

Teriparatidas

Strength

20 µg/80 µl

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)

H05AA02, Teriparatide

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2022-03-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled pen	80 µl
Teriparatidas	20 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
108358	94462	1094462	užpildytas švirkštiklis	2,4 ml N1 (28 dozės)		Receptinis	EU/1/22/1628/001	Netiekiama	2025-07-30	2025-12-31	Yes	2025-08-01	2025-12-31
108359	94463	1094463	užpildytas švirkštiklis	2,4 ml N3 (28 dozės)		Receptinis	EU/1/22/1628/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-24	Registruotas