AVONZA

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

EFAVIRENZ, TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE

Tersedia dari:

KIMIA FARMA Tbk. - Indonesia

INN (Nama Internasional):

EFAVIRENZ, TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE

Dosis:

400 MG /300 MG /300 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 1 BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT

Diproduksi oleh:

MYLAN LABORATORIES LIMITED - India

Tanggal Otorisasi:

2020-08-06

Karakteristik produk

AVONZA
TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/
EFAVIRENZ 300MG/300MG/400MG
PT. KIMIA FARMA
MYLAN LABORATORIES LTD.
Summary of Product Characteristics
AVONZA | 1
1.
NAME OF THE MEDICINAL PRODUCT
AVONZA Film Coated Tablet
Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400
mg
1
1
Trade names are not prequalified by WHO. This is under local DRA
responsibility. Throughout this WHOPAR
the proprietary name is given as an example only.
2.
PHARMACEUTICAL DOSAGE FORM
Film coated tablet
A white to off-white, film coated, oval, biconvex, beveled edge tablet
debossed with M on one
side of the tablet and TLE on the other side.
3.
COMPOSITION
Each film-coated tablet contains:
Tenofovir Disoproxil Fumarate
300 mg
Lamivudine USP
300 mg
Efavirenz USP
400 mg
For excipients, see section 15
4.
PHARMACOLOGICAL PROPERTIES
4.1
Pharmacodynamic Properties
▪
PHARMACOTHERAPEUTIC GROUP: Antivirals for treatment of HIV infections,
combinations
▪
ATC CODE: J05AR11
▪
PHARMACOLOGICAL CLASSIFICATION: 7.13 Antivirals
▪
MECHANISM OF ACTION : Tenofovir Disoproxil
Fumarate/Lamivudine/Efavirenz
Film Coated Tablets 300 mg/300 mg/400 mg are a fixed dose combination
of
Antiviral drugs Tenofovir Disoproxil Fumarate, Lamivudine and
Efavirenz
4.2 PHARMACOKINETIC PROPERTIES
Tenofovir
Disoproxil
Fumarate/Lamivudine/Efavirenz
Film
Coated
Tablets
300
mg/300 mg/400 mg are bioequivalent to Viread® tablets ( Tenofovir
Disoproxil
Fumarate Tablet), Epivir® Tablet (Lamivudine 300 mg tablet) plus two
tablets of
Efamat® (Efavirenz 200 mg tablet) when single doses were administered
to healthy
volunteers
under
fasting
conditions.
Tenofovir
Disoproxil
Fumarate/Lamivudine/Efavirenz Film Coated Tablets 300 mg/300 mg/400 mg
has not
been
evaluated
under
fed
conditions.
Efavirenz
and
other
products
containing
Efavirenz should be administered under fasted conditions.
DISETUJUI OLEH BPOM : 17/07/2020
EREG10030311800034
AVONZA
TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/
EFAVIRENZ 300MG/300MG/400MG
PT. KIMIA FARMA
MYLAN LABORATORIES LTD.
Summary of Pro