REKOVELLE

This brand name is authorized in Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom

Active ingredients

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

1 Follitropin delta UNII 2M2GGL7HUP - FOLLITROPIN DELTA

Follitropin delta is a recombinant human FSH used for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART). Because follitropin delta is produced in the human cell line PER.C6, the glycosylation profile is different from follitropin alfa and follitropin beta. Read about Follitropin delta

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
REKOVELLE Solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
G03GA10		G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03G Gonadotropins and other ovulation stimulants → G03GA Gonadotropins
Discover more medicines within G03GA10

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11414R, 11430N, 11431P
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 521418030006402, 521418030006502, 521418030006602, 521418030006702, 521418030006802, 521418030006902
Country: CA	Health Products and Food Branch	Identifier(s): 02474077, 02474085, 02474093, 02487462, 02487470, 02487489
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 209-MBE-0721
Country: EE	Ravimiamet	Identifier(s): 1735578, 1735589, 1735590, 1772007, 1772018, 1772029
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1161150004, 1161150005, 1161150006
Country: FR	Base de données publique des médicaments	Identifier(s): 64391519, 65010266, 67298244
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 345531, 345538, 345542, 374959, 374962, 375211
Country: HK	Department of Health Drug Office	Identifier(s): 66026, 66027, 66028
Country: IE	Health Products Regulatory Authority	Identifier(s): 88930, 88931, 88937
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8123, 8124, 8344
Country: IT	Agenzia del Farmaco	Identifier(s): 045226014, 045226026, 045226038, 045226040, 045226053, 045226065
Country: JP	医薬品医療機器総合機構	Identifier(s): 2413407G1025, 2413407G2021, 2413407G3028
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1081846, 1081847, 1081848, 1084610, 1084611, 1084612
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 139807, 139815, 139823
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 20017, 20018, 20534
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100382085, 100382091, 100382100
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W63287001, W63287002, W63288001, W63288002, W63289001, W63289002
Country: SG	Health Sciences Authority	Identifier(s): 15537P, 15538P, 15539P, 15650P, 15651P, 15652P