VILENA 5

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

제품 특성 요약 제품 특성 요약 (SPC)
01-01-2020

유효 성분:

LENALIDOMIDE

제공처:

PRATAPA NIRMALA - Indonesia

INN (International Name):

LENALIDOMIDE

복용량:

5,0 Mg

약제 형태:

KAPSUL

패키지 단위:

DUS, 3 BLISTER @ 7 KAPSUL

Manufactured by:

SYNTHON CHILE LTDA. - Chile

승인 날짜:

2020-02-09

제품 특성 요약

                                VILENA
LENALIDOMIDE
Capsules 2.5 mg
Capsules 5 mg
Capsules 7.5 mg
Capsules 10 mg
Capsules 15 mg
Capsules 20 mg
Capsules 25 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vilena 2.5 mg capsules
: Each capsule contains 2.5 mg of lenalidomide.
Vilena 5 mg capsules
: Each capsule contains 5 mg of lenalidomide.
Vilena 7.5 mg capsules
: Each capsule contains 7.5 mg of lenalidomide.
Vilena 10 mg capsules
: Each capsule contains 10 mg of lenalidomide.
Vilena 15 mg capsules
: Each capsule contains 15 mg of lenalidomide.
Vilena 20 mg capsules
: Each capsule contains 20 mg of lenalidomide.
Vilena 25 mg capsules
: Each capsule contains 25 mg of lenalidomide.
PHARMACEUTICAL FORM
Vilena 2.5 mg capsules
Hard gelatin capsule, with an opaque white body and opaque green cap
with “L9NL” and “2.5” printed radial on
body. Capsule size : 4
Vilena 5 mg capsules
Hard gelatin capsule, with an opaque white body and opaque white cap
with “L9NL” and “5” printed radial on body.
Capsule size : 2
Vilena 7.5 mg capsules
Hard gelatin capsule, with an opaque white body and opaque yellow cap
with “L9NL” and “7.5” printed radial on
body. Capsule size : 2
Vilena 10 mg capsules
Hard gelatin capsule, with an opaque yellow body and opaque green cap
with “L9NL” and “10” printed radial on
body. Capsule size : 0
Vilena 15 mg capsules
Hard gelatin capsule, with an opaque white body and opaque blue cap
with “L9NL” and “15” printed radial on body.
Capsule size : 0
Vilena 20 mg capsules
Hard gelatin capsule, with an opaque blue body and opaque green cap
with “L9NL” and “20” printed radial on
body. Capsule size : 0
Vilena 25 mg capsules
Hard gelatin capsule, with an opaque white body and opaque white cap
with “L9NL” and “25” printed radial on
body. Capsule size : 0
THERAPEUTIC INDICATIONS
Multiple myeloma
DISETUJUI OLEH BPOM : 31/01/2020
EREG10019111900122 EREG10019111900198
EREG10019111900199 EREG10019111900200
EREG10019111900201 EREG10019111900202
EREG10019111900203
Vilena as combination therapy with dexam
                                
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