TWYNSTA

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

Active ingredients

The drug TWYNSTA contains a combination of these active pharmaceutical ingredients (APIs):

1	Telmisartan UNII U5SYW473RQ - TELMISARTAN
	Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan selectively binds the AT1 receptor. The binding is long-lasting.
	Read more about Telmisartan
2	Amlodipine UNII 864V2Q084H - AMLODIPINE BESYLATE
	Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.
	Read more about Amlodipine

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-7797	Tablet	Twynsta 40/5 mg TAB 5 mg; 40 mg 4 X 7		29/09/2022
A4-7798	Tablet	TWYNSTA 40/10MG TABLETS TAB 10 mg; 40 mg 4 X 7	173 AMS-PP-325341 TWYNSTA 40/10MG TABLETS TELMISARTAN 40MG + AMLODIPINE 10MG Telmisartan 40mg and Amlodipine 10mg A4-7798 Drugs Imported Products 47 POM 1 9/15/2023 FENSYL MHP CONSULTING LIMITED, KOFO ABAYOMI STREET APAPA LAGOS LAGOS 8033221004 fensylmhpconsultingltd@gmail.com Rottendorf Pharma GmbH, Am Fleigendahl 3, 59320 Ennigerloh, Germany , Germany	21/12/2023
A4-7799	Tablet	Twynsta 80/5 mg TAB 5 mg; 80 mg 4 X 7		25/09/2024
A4-7800	Tablet	Twynsta 80/10 mg Tablet TAB 10 mg; 80 mg	Each tablet contains: Telmisartan 80 mg and Amlodipine (as Amlodipine besilate) 10 mg	25/09/2024

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TWYNSTA Tablet	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		Classification
C09DB04	Telmisartan and amlodipine	C Cardiovascular system → C09 Agents acting on the renin-angiotensin system → C09D Angiotensin II antagonists, combinations → C09DB Angiotensin II antagonists and calcium channel blockers
Discover more medicines within C09DB04

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	8978M, 8979N, 8980P, 8981Q
CA	Health Products and Food Branch	02371022, 02371030, 02371049, 02371057
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00435904, 00438920, 03687629, 05547714, 05547743, 05547789, 05547826, 07605048, 09094907, 09094913, 09321763, 09404259, 09404265, 09481314, 09481403, 09482058, 09605650, 09605667, 09605673, 09640646, 09640669, 09687435, 09687458, 09715605, 09715611, 09716616, 09930597, 09941589, 10101653, 10101676, 11157383, 11157408, 11691473, 11691496, 11893946, 11893952, 11893969, 12442938, 12453155, 12453178, 12526339, 12526351, 12575875, 12575881, 13425681, 13581139, 13830849, 14001256, 14001262, 14001279, 14001285, 15243458, 15377377, 15406937, 15888706, 15888712, 16002716, 16511702
EE	Ravimiamet	1499171, 1499182, 1499193, 1499205, 1499216, 1499227, 1499238, 1499306, 1499317, 1499328, 1499339, 1499340, 1499351, 1499362, 1499373, 1499384, 1499395, 1499407, 1499418, 1499429, 1499430, 1499441, 1499452, 1499463, 1499474, 1499485, 1499496, 1499508
ES	Centro de información online de medicamentos de la AEMPS	10648016, 10648016IP, 10648023, 10648023IP
FR	Base de données publique des médicaments	64505047, 66797543, 67700337, 69032413
HK	Department of Health Drug Office	60510, 60511, 60512, 60513
IE	Health Products Regulatory Authority	42422, 42423, 42424, 42425, 42426, 42434, 42435, 42436, 42437
IT	Agenzia del Farmaco	040332013, 040332025, 040332037, 040332049, 040332052, 040332064, 040332076, 040332088, 040332090, 040332102, 040332114, 040332126, 040332138, 040332140, 040332153, 040332165, 040332177, 040332189, 040332191, 040332203, 040332215, 040332227, 040332239, 040332241, 040332254, 040332266, 040332278, 040332280
LT	Valstybinė vaistų kontrolės tarnyba	1057196, 1057197, 1057198, 1057199, 1057200, 1057201, 1057202, 1057203, 1057204, 1057205, 1057206, 1057207, 1057208, 1057209, 1057211, 1057212, 1057213, 1057214, 1057215, 1057216, 1057217, 1057218, 1057219, 1057220, 1057221, 1057222, 1057223, 1057224
NG	Registered Drug Product Database	A4-7797, A4-7798, A4-7799, A4-7800
PL	Rejestru Produktów Leczniczych	100236099, 100236107, 100236113, 100236120
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W55966001, W55966002, W55966003, W55966004, W55966005, W55966006, W55966007, W55967001, W55967002, W55967003, W55967004, W55967005, W55967006, W55967007, W55968001, W55968002, W55968003, W55968004, W55968005, W55968006, W55968007, W55969001, W55969002, W55969003, W55969004, W55969005, W55969006, W55969007
SG	Health Sciences Authority	14008P, 14009P, 14010P, 14011P
TN	Direction de la Pharmacie et du Médicament	11533051, 11533052, 11533053, 11533054
US	FDA, National Drug Code	0597-0124, 0597-0125, 0597-0126, 0597-0127
ZA	Health Products Regulatory Authority	44/7.1.3/0857, 44/7.1.3/0858, 44/7.1.3/0859, 44/7.1.3/0860