Lubion

Medicinal product

(Invented) name

Lubion

Active substance (s)

Progesteronas

Strength

25 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03DA04, Progesterone

Marketing authorisation holder

IBSA Farmaceutici Italia Srl, Italija

Date of authorisation

2023-09-27

Date of renewal

Documents

5242 Pakuotės lapelis 2025 07 30.docx

5242 Lubion svirkste PL 2025 07 30.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

AT/H/1015/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Užpildytame švirkšte (1,112 ml) yra:	1.112 ml
Progesteronas	25 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
111714	97828	1097828	užpildytas švirkštas	N7		Receptinis	LT/1/23/5242/001	Netiekiama	-	-	No	-	-
111715	97829	1097829	užpildytas švirkštas	N14		Receptinis	LT/1/23/5242/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-27	Registruotas