REKOVELLE

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

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 more about Follitropin delta

Medication package inserts

Below package inserts are available for further reading:

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