CRESTOR

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK, United States.

Active ingredients

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

1	Rosuvastatin UNII 83MVU38M7Q - ROSUVASTATIN CALCIUM
	Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase. Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.
	Read more about Rosuvastatin

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-5402	Tablet	Crestor 5 mg Tablets TAB 5 mg		02/12/2021
A4-5403	Tablet	Crestor 10 mg Tablets TAB 10 mg		02/12/2021
A4-5404	Tablet	Crestor 20 mg Tablets TAB 20 mg		02/12/2021
A4-5405	Tablet	Crestor 40 mg Tablets TAB 40 mg		02/12/2021

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
CRESTOR 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
C10AA07	Rosuvastatin	C Cardiovascular system → C10 Lipid modifying agents → C10A Lipid modifying agents, plain → C10AA HMG CoA reductase inhibitors
Discover more medicines within C10AA07

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	2574L, 2584B, 2590H, 2594M, 2606E, 2609H, 2628H, 2636R
BR	Câmara de Regulação do Mercado de Medicamentos	502305301118212, 502305302114210, 502305304117217, 502305305113215, 502305307116319, 502305308112317, 502319060034103
CA	Health Products and Food Branch	02247162, 02247163, 02247164, 02265540
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00185324, 00185399, 00185442, 00185560, 00316223, 00321721, 05484451, 05484468, 05486504, 05486510, 05486533, 05486556, 05900702, 05907609, 05907621, 06143686, 06143692, 06149602, 06149619, 06149654, 06429081, 06429129, 06442265, 06442288, 06562584, 06574601, 06808766, 06808772, 06836768, 07745217, 07745246, 07758639, 10087344, 10100547, 11174068, 11293608, 11519136, 11519142, 12394317, 12509909, 12593494, 14242327, 16085151, 16085168, 16085174, 16319382, 16319399, 16914044, 16939995, 16940047, 16940053, 17447981, 17447998
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	25.522-01-04, 25.523-01-04, 25.578-02-04, 27.519-1-11-11
EE	Ravimiamet	1106019, 1106031, 1106042, 1106053, 1106064, 1106075, 1106086, 1106097, 1106109, 1106110, 1106121, 1106132, 1106143, 1106154, 1106165, 1106176, 1310016, 1310027, 1362631, 1362642, 1362653, 1362664, 1362675, 1362686, 1362697, 1362709, 1362710
ES	Centro de información online de medicamentos de la AEMPS	035885058, 035885209, 035885209IP, 70243, 70244, 70334
FI	Lääkealan turvallisuus- ja kehittämiskeskus	151168, 197005, 407798, 415955, 461064, 482603, 487301, 561007, 576640, 582737
FR	Base de données publique des médicaments	63191743, 67273757, 68479386
GB	Medicines & Healthcare Products Regulatory Agency	138578, 138580, 138584, 138586, 142118, 142124, 142128, 142129, 161548, 161549, 180553, 182287, 182289, 182300, 185721, 187458, 198703, 373581, 41711, 41715, 41722, 97476
HK	Department of Health Drug Office	51740, 51741, 51742, 54416
IE	Health Products Regulatory Authority	18905, 19164, 19202, 19207, 19226, 19238, 19260, 19261, 19262, 66914, 66915, 66916, 66917
IL	מִשְׂרַד הַבְּרִיאוּת	4706, 4707, 4708
IT	Agenzia del Farmaco	035885058, 035885209, 035885351, 035885502
JP	医薬品医療機器総合機構	2189017F1022, 2189017F2029, 2189017F3025, 2189017F4021
LT	Valstybinė vaistų kontrolės tarnyba	1004293, 1004294, 1011070, 1011071, 1033012, 1050854
MT	Medicines Authority	MA046/02001, MA046/02002, MA046/02003, MA046/02004, PI770/13401A, PI770/13402A, PI770/13403A, PI908/05101B, PI908/05101C, PI908/05102A, PI908/05103A, PI908/05104A
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	177M2003
NG	Registered Drug Product Database	A4-5402, A4-5403, A4-5404, A4-5405
NL	Z-Index G-Standaard, PRK	201030, 201049, 201057, 201065
NZ	Medicines and Medical Devices Safety Authority	10475, 10476, 10477, 12024
PL	Rejestru Produktów Leczniczych	100135145, 100185686, 100188130, 100188271, 100339994, 100434818, 100434824, 100445035, 100446098, 100459391
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65077001, W65077002, W65077003, W65078001, W65078002, W65078003, W65079001, W65079002, W65079003, W65080001
SG	Health Sciences Authority	12157P, 12158P, 12159P, 13154P
TN	Direction de la Pharmacie et du Médicament	4833064, 4833065, 4833066
TR	İlaç ve Tıbbi Cihaz Kurumu	8699786090163, 8699786090187, 8699786090248, 8699786090255, 8699786090262, 8699786090279, 8699786092761, 8699786092778
US	FDA, National Drug Code	0310-0751, 0310-0752, 0310-0754, 0310-0755, 50090-1097, 55154-6921, 55289-932, 55289-935, 63629-3381, 63629-4372, 63629-6372, 63629-6427, 63629-6924
ZA	Health Products Regulatory Authority	36/7.5/0349, 36/7.5/0350, 36/7.5/0351, 41/7.5/0298