Teriparatide SUN

Medicinal product

(Invented) name

Teriparatide SUN

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)

ATC code (s)

H05AA02, Teriparatide

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2022-11-18

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(3)

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
109906	96013	1096013	užpildytas švirkštiklis	N1 (28 dozės)		Receptinis	EU/1/22/1697/001	Netiekiama	-	-	No	-	-
109907	96014	1096014	užpildytas švirkštiklis	N3 (3×28 dozės)		Receptinis	EU/1/22/1697/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-11-18	Registruotas