BLEOCIN
Country: Indonesia
Language: Indonesian
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
Summary of Product characteristics
(SPC)
01-01-2021
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Active ingredient:
BLEOMYCIN HYDROCHLORIDE
Available from:
KALBE FARMA - Indonesia
INN (International Name):
BLEOMYCIN HYDROCHLORIDE
Dosage:
15 Mg
Pharmaceutical form:
SERBUK INJEKSI
Units in package:
DUS,1 VIAL @ 15 MG
Manufactured by:
NIPPON KAYAKU CO. LTD. - Japan
Authorization date:
2021-12-06
Summary of Product characteristics
Specification (Packaging Material)
SpecContDP000774/1
This document has been electronically signed
Approved by: Seimtiarti Wijaya Kusumanti Dewi, R&D, 24 Nov 2020, Agung
Martupa Bukit Leo M, QA, 25 Nov 2020
BLEOCIN 15 MG POWDER FOR SOLUTION FOR
INJECTION (Indonesia) Specification (Leaflet)
Effective date:25 Nov 2020
In house
Page 3 of 5
CONFIDENTIAL
PT Kalbe Farma Tbk
BLEOCIN (Indonesia) ACTD
Variation 2021
8.1.2 Package Insert, , Page 56 of 73
DISETUJUI OLEH BPOM: 15/06/2021
ID: EREG100221VR12000100
Specification (Packaging Material)
SpecContDP000774/1
This document has been electronically signed
Approved by: Seimtiarti Wijaya Kusumanti Dewi, R&D, 24 Nov 2020, Agung
Martupa Bukit Leo M, QA, 25 Nov 2020
BLEOCIN 15 MG POWDER FOR SOLUTION FOR
INJECTION (Indonesia) Specification (Leaflet)
Effective date:25 Nov 2020
In house
Page 4 of 5
CONFIDENTIAL
PT Kalbe Farma Tbk
BLEOCIN (Indonesia) ACTD
Variation 2021
8.1.2 Package Insert, , Page 57 of 73
DISETUJUI OLEH BPOM: 15/06/2021
ID: EREG100221VR12000100
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