NUROFEN

This brand name is authorized in Nigeria. It is also authorized in Austria, Croatia, Cyprus, Estonia, France, Germany, Hong Kong SAR China, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Ibuprofen UNII WK2XYI10QM - IBUPROFEN
	Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.
	Read more about Ibuprofen

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-5985	Caplet	NUROFEN 200mg CAPLET TAB 200 mg 1 X 12pack	78 RNW-PP-239803 NUROFEN 200mg CAPLET IBUPROFEN Ibuprofen 200mg,,Colloidal Anhydrous Silica 1.0mg,Croscarmellose Sodium 30.0mg,Stearic Acid 2.0mg,Sodium Laurilsulfate 0.5mg,Sodium Citrate 43.5mg,Titanium Dioxide 1.4mg A4-5985 Drugs Imported Products 112pack Over The Counter (OTC) 11/24/2021 RECKITT BENCKISER NIGERIA LIMITED, HERITAGE PLACE, 21 LUGARD AVENUE , IKOYI LAGOS LAGOS 8174600370 Uzo.Amatokwu@reckitt.com RECKITT BENCKISER INTERNATIONAL LIMITED, NOTTINGHAM SITE THANE RD,NOTTINGHAM NOTTINGHAMSHIRE NG 90 2DB,UNITED KINGDOM, United Kingdom	30/11/2023
B4-4444	Capsule	Nurofen Express Liquid 200 mg Capsules (duplicate, different product) CAP 200 mg		21/12/2020
B4-5558	Capsule	Nurofen Express Liquid 400 mg Capsules CAP 400 mg		21/12/2020

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
NUROFEN Coated tablet	MPI, EU: SmPC	Health Products Regulatory Authority (IE)
NUROFEN DURANCE Medicated plaster	MPI, EU: SmPC	Health Products Regulatory Authority (IE)

Medicine classification

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

ATC Group		Classification
M01AE01	Ibuprofen	M Musculo-skeletal system → M01 Antiinflammatory and antirheumatic products → M01A Antiinflammatory and antirheumatic products, non-steroids → M01AE Propionic acid derivatives
Discover more medicines within M01AE01
M02AA13	Ibuprofen	M Musculo-skeletal system → M02 Topical products for joint and muscular pain → M02A Topical products for joint and muscular pain → M02AA Antiinflammatory preparations, non-steroids for topical use
Discover more medicines within M02AA13

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00146519, 01170187, 02547582, 03443838, 06789419, 06789425, 07776465, 07776471, 08794436, 08794442, 08794459, 11128051, 11550548, 12741888, 13475265, 16205690, 16205709, 16516846, 16536808, 16538227, 16538233
EE	Ravimiamet	1029259, 1073304, 1133569, 1133592, 1285613, 1285624, 1285646, 1285657, 1285668, 1335361, 1335372, 1335383, 1335394, 1335406, 1335417, 1335428, 1335439, 1335440, 1335451, 1335462, 1335473, 1386479, 1386604, 1386615, 1386626, 1386671, 1386682, 1386693, 1386705, 1607521, 1637096, 1637108, 1683435, 1683446, 1683457, 1683468, 1683479, 1683480, 1683491, 1683503, 1683514, 1683525, 1683536, 1683547, 1683558, 1683569, 1683570, 1683581, 1769654, 1769665, 1769676, 1769687, 1769698, 1836198, 1836222
ES	Centro de información online de medicamentos de la AEMPS	67968, 68517, 78466, 78530, 82519
FR	Base de données publique des médicaments	60305960, 60830246, 61471853, 63005402, 64911902, 65750786, 67510932, 68354856, 69457752, 69543863
GB	Medicines & Healthcare Products Regulatory Agency	102397, 115076, 115077, 119346, 119347, 119348, 119350, 139407, 139426, 14595, 146007, 14601, 14603, 14605, 14607, 14608, 14609, 147410, 215242, 22565, 236497, 236499, 313932, 313946, 313950, 313953, 313958, 323202, 323909, 357487, 357488, 38692, 386928, 386930, 46040, 46057, 80617, 91644, 91645, 91647
HK	Department of Health Drug Office	51501, 58322, 64198, 64199
HR	Agencija za lijekove i medicinske proizvode	HR-H-023698858, HR-H-140153836, HR-H-151406116, HR-H-534899919, HR-H-756646540, HR-H-821340280, HR-H-846940596, HR-H-934065674, HR-H-987481558
IL	מִשְׂרַד הַבְּרִיאוּת	182, 3945, 3999, 5080, 5081, 5087, 5197, 5198, 5225, 5226, 5250, 5262, 5263, 5391, 5409, 5410, 5464, 5494, 5497
LT	Valstybinė vaistų kontrolės tarnyba	1011544, 1015741, 1015742, 1030746, 1030747, 1035012, 1035013, 1058611, 1058612, 1058613, 1058614, 1058615, 1058616, 1059887, 1072175, 1072190, 1076350, 1081794, 1081795, 1081796, 1081797, 1081798, 1081799, 1081800, 1081801, 1081802, 1081803, 1081804, 1081805, 1081806, 1081807, 1081808, 1091577, 1091578
MT	Medicines Authority	AA1228/01401, AA908/08004, MA1447/00102, MA1447/00103, MA1447/00402, MA190/00402, PI1438/09801A, PI908/08001A
NG	Registered Drug Product Database	A4-5985, B4-4444, B4-5558
NL	Z-Index G-Standaard	14132265, 15092356
NL	Z-Index G-Standaard, PRK	17760, 197998, 27251, 27278, 47872, 54801, 59072, 67962, 69248
NZ	Medicines and Medical Devices Safety Authority	11233, 11234, 11602, 11604, 11606, 12185, 12367, 12370, 12823, 12824, 12825, 12826, 12827, 13266, 13267, 14111, 14156, 14859, 14860, 17637, 19916, 20766, 8574, 991, 9922
PL	Rejestru Produktów Leczniczych	100090945, 100094877, 100096497, 100114806, 100161987, 100162900, 100165459, 100172755, 100181820, 100191103, 100198424, 100216464, 100229372, 100241686, 100241692, 100274987, 100307830, 100335677, 100335683, 100338836, 100339899, 100343323, 100356834, 100367230, 100392043, 100393290, 100393462, 100397661, 100400512, 100404591, 100411510, 100418742, 100418765, 100419517, 100429941, 100429993, 100435522, 100438816, 100444828, 100446951, 100464710
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65692001, W65692002, W65692003, W65692004, W65692005, W65692006, W65692007, W65943002, W65943003, W66067001, W66067002, W66067003, W66067004, W66067005, W66067006, W66069001, W66069002, W66069003, W66069004, W66069005, W66069006, W66069007, W66070001, W66070002, W66070003, W66070004, W66070005, W66072001, W66073001, W66073002, W66073003, W66074001, W66083001, W66083002, W66083003, W66083004, W66083005, W66084001, W66084002, W66084003, W66084004, W66084005, W66085001, W66085002, W66085003, W66085004, W66085005, W66085006, W66085007, W66085008, W66085009, W66088001, W66088002, W66088003, W66088004, W66088005, W66088006, W66088007, W66088008, W66088009, W66088010, W66088011, W66088012, W66094001, W66094002, W66094003, W66094004, W66094005, W66094006, W66094007, W66094008, W66094009, W66094010, W66094011, W66094012, W66094013, W66094014, W66094015, W66094016, W66095002, W66095004, W66095006, W67838001, W67838002, W67838003, W67838004, W69383001
SG	Health Sciences Authority	09488P, 10923P, 10924P, 11879P, 11880P, 14366P, 14367P, 14561P, 14562P, 14587P, 14958P, 15309P
TR	İlaç ve Tıbbi Cihaz Kurumu	8690570120028, 8690570120035, 8690570120042, 8690570700022
ZA	Health Products Regulatory Authority	31/2.7/0466, 35/2.7/0077, 36/2.7/0029, 36/2.7/0184, 36/3.1/0433, 44/2.7/0386, 45/2.7/0781, 47/2.7/0289, 49/2.7/0178, 49/2.7/0179, A40/2.7/0092, S/2.7/123, W/2.7/142, W/2.7/49