Orencia

Medicinal product

(Invented) name

Orencia

Active substance (s)

Abataceptas

Strength

125 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)

L04AA24, Abatacept

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2007-05-21

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	1 ml
Abataceptas	125 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
54132	68120	1068120	užpildytas švirkštas	N1		Receptinis	EU/1/07/389/004	Netiekiama	-	-	No	-	-
54135	68123	1068123	užpildytas švirkštas	N4		Receptinis	EU/1/07/389/005	Netiekiama	-	-	No	-	-
54136	68124	1068124	užpildytas švirkštas	N12		Receptinis	EU/1/07/389/006	Netiekiama	-	-	No	-	-
54137	68125	1068125	užpildytas švirkštas	N1 (su adatos apsauga)		Receptinis	EU/1/07/389/007	Netiekiama	-	-	No	-	-
54138	68126	1068126	užpildytas švirkštas	N4 (su adatos apsauga)		Receptinis	EU/1/07/389/008	Netiekiama	-	-	No	-	-
54139	68127	1068127	užpildytas švirkštas	N12 (su adatos apsauga)		Receptinis	EU/1/07/389/009	Netiekiama	-	-	No	-	-
57492	71608	1071608	užpildytas švirkštas	N3 (su adatos apsauga)		Receptinis	EU/1/07/389/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-05-21	Registruotas