Terrosa

Medicinal product

(Invented) name

Terrosa

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2017-01-04

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
110728	96839	1096839	užpildytas švirkštiklis	2,4 ml N1 (28 dozės)		Receptinis	EU/1/16/1159/004	Netiekiama	-	-	No	-	-
110729	96840	1096840	užpildytas švirkštiklis	2,4 ml N3 (28 dozės)		Receptinis	EU/1/16/1159/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-01-04	Registruotas