Semglee

Medicinal product

(Invented) name

Semglee

Active substance (s)

Insulinas glarginas

Strength

100 V/ml

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)

A10AE04, Insulin glargine

Marketing authorisation holder

Biosimilar Collaborations Ireland Limited, Airija

Date of authorisation

2018-03-23

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	1 ml
Insulinas glarginas	100 V/ml

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
99237	85343	1085343	užpildytas švirkštiklis	3 ml N1		Receptinis	EU/1/18/1270/001	Netiekiama	-	-	No	-	-
99238	85344	1085344	užpildytas švirkštiklis	3 ml N3		Receptinis	EU/1/18/1270/002	Netiekiama	-	-	No	-	-
99239	85345	1085345	užpildytas švirkštiklis	3 ml N5		Receptinis	EU/1/18/1270/003	Netiekiama	-	-	No	-	-
102479	88580	1088580	užpildytas švirkštiklis	3 ml N10		Receptinis	EU/1/18/1270/004	Netiekiama	-	-	No	-	-
102480	88581	1088581	užpildytas švirkštiklis	3 ml N10 (2x5)		Receptinis	EU/1/18/1270/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-03-23	Registruotas