Țară: Indonezia
Limbă: indoneziană
Sursă: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
AMLODIPINE BESILATE; OLMESARTAN MEDOXOMIL
PFIZER INDONESIA - Indonesia
AMLODIPINE BESILATE; OLMESARTAN MEDOXOMIL
40/10 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
PFIZER MANUFACTURING DEUTSCHLAND Gmbh - Germany
2019-06-18
Generic Name: Olmesartan medoxomil-Amlodipine besylate Trade Name: NORMETEC CDS Effective Date: May, 2020 Supersedes: June, 2014 Approved by BPOM: 2016-0019627, 2018-0035315, 2020-0060226, 2017-0026039 Page 1 of 22 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Product Document Title: Olmesartan medoxomil-Amlodipine besylate Trade Name: NORMETEC CDS Effective Date: May, 2020 Supersedes: June, 2014 DESCRIPTION NORMETEC is a combination of the angiotensin II receptor blocker (ARB) olmesartan medoxomil and the calcium channel receptor blocker (CCB) amlodipine besylate. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[_p-_(_o-_1_H_-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3- carbonate. Its empirical formula is C 29 H 30 N 6 O 6 . The structural formula for olmesartan medoxomil is: Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]- 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 CIN 2 O 5 • C 6 H 6 O 3 S. DISETUJUI OLEH BPOM : 02/03/2021 ID : EREG10024112000478 EREG10024112000479 EREG10024112000480 Generic Name: Olmesartan medoxomil-Amlodipine besylate Trade Name: NORMETEC CDS Effective Date: May, 2020 Supersedes: June, 2014 Approved by BPOM: 2016-0019627, 2018-0035315, 2020-0060226, 2017-0026039 Page 2 of 22 The structural formula for amlodipine besylate is: PHARMACEUTICAL FORM NORMETEC is available for oral use as film-coated tablets in the following strengths: • Olmesartan medoxomil 20 mg plus amlodipine 5 mg (20/5 mg). White, round, film-coated tablet with C73 debossed on one side. • Olmesartan medoxomil 40 mg plus amlodipine 5 mg (40/5 mg). Cream, round, film-coated tablet with C75 debossed on one side. • Olmesartan medoxomil 40 mg plus amlodipine 10 mg (40/10 mg). Brownish-red, round, film-coat Citiți documentul complet