GLUCOPHAGE

This brand name is authorized in Nigeria. It is also authorized in Albania, Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Italy, Malta, Poland, Romania, Singapore, South Africa, Tunisia, Turkey, UK, United States.

Active ingredients

The drug GLUCOPHAGE contains one active pharmaceutical ingredient (API):

1	Metformin UNII 786Z46389E - METFORMIN HYDROCHLORIDE
	Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
	Read more about Metformin

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-6234	Tablet	Metformin Hydrochloride TAB 1000 mg		02/12/2021
B4-5413	Tablet	Glucophage 850 mg Tablet TAB 850 mg	Film-coated tablet	02/12/2021
B4-8203	Tablet	GLUCOPHAGE XR 1000MG TABLET TAB 1000 mg 3x10	37 RNW-PP-299892 GLUCOPHAGE XR 1000MG TABLET METFORMIN HYDROCHLORIDE Metformin Hydrochloride 1000mg, Magnesium Stearate, Carmellose Sodium and Hypromellose B4-8203 Drugs Imported Products 310 Prescription Only Medicine (POM) 12/20/2022 MERCK PHARMACEUTICAL AND LIFE SCIENCES LIMITED, CHURCHGATE TOWERS VICTORIA ISLAND LAGOS 16323445 Regulatory_NEA@merckgroup.com Merck Sante s.a.s. 2 rue du Pressoir vert 45400 SEMOY FRANCE, 2 Rue du Pressoir Vert, 45400 Semoy, France, France	06/07/2023
B4-8204	Tablet	GLUCOPHAGE XR 750MG TABLET TAB 750 mg 2 X 15	38 RNW-PP-299886 GLUCOPHAGE XR 750MG TABLET METFORMIN HYDROCHLORIDE Metformin Hydrochloride 750mg, Magnesium Stearate, Carmellose Sodium and Hypromellose B4-8204 Drugs Imported Products 215 POM 1 12/20/2022 MERCK PHARMACEUTICAL AND LIFE SCIENCES LIMITED, CHURCHGATE TOWERS VICTORIA ISLAND LAGOS 16323445 Regulatory_NEA@merckgroup.com Merck Sante s.a.s. 2 rue du Pressoir vert 45400 SEMOY FRANCE, 2 Rue du Pressoir Vert, 45400 Semoy, France, France	06/07/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
GLUCOPHAGE Tablet / Extended-release tablet	MPI, US: SPL/PLR	FDA, National Drug Code (US)
GLUCOPHAGE Film-coated tablet	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
A10BA02	Metformin	A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10B Blood glucose lowering drugs, excl. insulins → A10BA Biguanides
Discover more medicines within A10BA02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AL	Fondi i Sigurimit të Detyrueshëm të Kujdesit Shëndetësor	411/201
CA	Health Products and Food Branch	02099233, 02162849
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	01332709, 01332738, 01690811, 02160452, 04024546, 04349320
EE	Ravimiamet	1138520, 1782446
FI	Lääkealan turvallisuus- ja kehittämiskeskus	008023, 010730, 374231
FR	Base de données publique des médicaments	61052830, 67547090, 68583940, 68915976
GB	Medicines & Healthcare Products Regulatory Agency	137487, 137491, 14331, 14356, 153679, 153681, 161875, 381379, 381380, 381382, 381383, 381385, 381386, 387710, 89908, 89909
HK	Department of Health Drug Office	27087, 27705, 50383, 52624, 57185, 60306, 65855, 66531
HR	Agencija za lijekove i medicinske proizvode	HR-H-213830516, HR-H-310851737, HR-H-536355467, HR-H-669077962, HR-H-839391381, HR-H-841365882
IE	Health Products Regulatory Authority	27723, 27731, 27742
IT	Agenzia del Farmaco	017758018, 017758020, 017758069, 040628024, 040628048, 040628063
MT	Medicines Authority	AA1228/01501, AA1228/01502, AA1438/07401, AA521/05002, AA770/10301, AA770/10302, AA770/11101, AA770/11102, AA908/20501, AA908/20502, PI908/02701A
NG	Registered Drug Product Database	04-6233, 04-6234, B4-5413, B4-8203, B4-8204, B4-9596
PL	Rejestru Produktów Leczniczych	100161645, 100177741, 100213112, 100229225, 100229231, 100246755, 100326307
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W13583008, W13583009, W13583010, W13583011, W13583012, W13583013, W13583014, W13583015, W13583016, W13583017, W13583018, W13583019, W13583020, W13583021, W13583022, W13583023, W13583024, W13583025, W13583026, W13872001, W13872002, W13872003, W13872004, W13872005, W13872006, W13872007, W13872008, W13872009, W13872010, W13872011, W13872012, W13872013, W13872014, W13872015, W13872016, W13872017, W13872018, W13872019, W13872020, W13872021, W13872022, W13872023, W13872024, W13872025, W13872026, W13872027, W13872028, W13872029, W13873001, W13873002, W13873003, W13873004, W13873005, W13873006, W13873007, W13873008, W13873009, W13873010, W13873011, W13873012, W13873013, W13873014, W13873015, W13873016, W13873017, W13873018, W13873019, W13873020, W13873021, W13873022, W13873023, W13873024, W43318001, W43318002, W63930002, W63930004, W63931002, W63931004
SG	Health Sciences Authority	04249P, 06988P, 11945P, 13249P, 13751P, 13994P
TN	Direction de la Pharmacie et du Médicament	3183041, 9043261, 9043262, 9043263
TR	İlaç ve Tıbbi Cihaz Kurumu	8699808090102, 8699808090119, 8699808090126, 8699808090133
US	FDA, National Drug Code	0087-6060, 0087-6063, 0087-6064, 0087-6071
ZA	Health Products Regulatory Authority	37/21.2/0272, 43/21.2/0185, 45/21.2/0066, A39/21.2/0027, F/21.2/145