Thalidomide BMS [Thalidomide Celgene]

Medicinal product

(Invented) name

Thalidomide BMS [Thalidomide Celgene]

Active substance (s)

Talidomidas

Strength

50 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AX02, Thalidomide

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2008-04-16

Date of renewal

Documents

Thalidomide paciento kortele.pdf

Thalidomide informuotumo apie rizika forma.pdf

Thalidomide BMS mokomoji medziaga pacientams.pdf

Thalidomide BMS mokomoji medziaga sveikatos prieziuros specialistams.pdf

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

Hard capsule	1 vnt.
Talidomidas	50 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
29695	32173	1032173	lizdinė plokštelė	N28		Receptinis	EU/1/08/443/001	Tiekiama	2025-10-24	-	Yes	2025-07-31	2025-12-31

Stadijos

Data	Stadija
2008-04-16	Registruotas