Register of Medicinal Products

XOFIGO

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1632293
Name of medicinal product:	XOFIGO
Active substances:	Radium ra 223 dichloride Estonian, English, Latin
ATC code:	V10XX03
Dosage form:	solution for injection
Route of administration:	intravenous use
Strengh:	1100kBq 1ml
Amount in package:	6ml 1TK
Legal status for supply*:	Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:	Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment (see section 4.4).
Safety features:	Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL):	EST
Labelling:
Last imported to Estonia:	November 16, 2023
:	This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines

Marketing authorization holder:	Bayer AG
Marketing authorization number:	EU/1/13/873
Marketing authorization issued on:	November 13, 2013
Marketing authorization expires on:	Unlimited
Marketing authorization procedure type:	Centralised

Reference price:
Under reference price:
Reference price of daily dose:

Description	Additional condition
Ei ole lubatud väljastada korduvretsepti

Entry/Changing date: September 20, 2023

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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