SOLYMBIC

Medicinal product

(Invented) name

SOLYMBIC

Active substance (s)

Adalimumabas

Strength

40 mg

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)

L04AB04, Adalimumab

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2017-03-22

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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	0.8 ml
Adalimumabas	40 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
68039	82601	1082601	užpildytas švirkštiklis	0,8 ml N1		Receptinis	EU/1/16/1163/006	Netiekiama	-	-	No	-	-
68040	82602	1082602	užpildytas švirkštiklis	0,8 ml N2		Receptinis	EU/1/16/1163/007	Netiekiama	-	-	No	-	-
68041	82603	1082603	užpildytas švirkštiklis	0,8 ml N4		Receptinis	EU/1/16/1163/008	Netiekiama	-	-	No	-	-
68042	82604	1082604	užpildytas švirkštiklis	0,8 ml N6		Receptinis	EU/1/16/1163/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-06-19	Išregistruotas
2017-03-22	Registruotas