MEDICINE DETAILS
Nubeqa
Active ingredient: Darolutamide
Neutral reference profile for an independent medicine-access consultancy enquiry about Nubeqa (Darolutamide). No medicine is offered for sale.
NEXT STEP
Choose the strength and pack
✓ If you are unsure, choose “I do not know”.
These options are not medical advice, a dosing recommendation, stock confirmation or a sale offer.
ABOUT THIS MEDICINE
What is Nubeqa used for?
Nubeqa (darolutamide) is used to treat non-metastatic castration-resistant prostate cancer (NM-CRPC).
The Food and Drug Administration (FDA) approved Nubeqa based on ARAMIS, a multicenter, double-blind, placebo-controlled clinical trial involving 1,509 patients. Patients were randomized to receive either 600 mg of darolutamide orally twice daily (955 patients) or a matching placebo (554 patients). All patients received a gonadotropin-releasing hormone (GnRH) analog concurrently or had previously undergone bilateral orchiectomy. The primary endpoint was metastasis-free survival (MFS). The median MFS for patients treated with Nubeqa was 40.4 months compared to 18.4 months for those receiving placebo.
Due to its mechanism of action, Nubeqa can harm unborn babies and cause pregnancy loss when given to a pregnant woman. Males with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose of Nubeqa.
Please refer to the full prescribing information for comprehensive details on the safety and efficacy of Nubeqa for the approved indication.
This information is general and is not medical advice. Talk to your doctor or pharmacist about any treatment decision.
RECORDED PRODUCT PROFILE
Nubeqa identity, dosage form and pack information.
The details below are assembled from current catalogue records. They must still be checked against the prescription, medicine box and an official regulatory record.
Recorded strength and pack options
Each row is shown only to help identify the product; it is not stock confirmation or a sale offer.
-
300 mg film-coated tablets · 112 tablets Catalogue organisation: PARANOVA PACK A/S
OFFICIAL SOURCES
Check the Nubeqa record at an official source.
Search for “Nubeqa” or “Darolutamide”. Finding a product in one source does not by itself confirm stock, authorisation in a particular country or suitability for a patient.
OFFICIAL EXTERNAL SOURCE
European Medicines Agency (EMA)
Search medicines evaluated by EMA by brand name or active substance. EMA also links to national registers for nationally authorised products.
↗ OFFICIAL EXTERNAL SOURCE Drugs@FDASearch FDA-approved human drug records by brand name or active ingredient, including current labelling where available.
↗SERVICE BOUNDARY
Information checking and independent enquiry support for Nubeqa.
OrphanDrug helps organise the product identity and recorded strength and pack details for an enquiry. It does not sell, take payment for, prescribe, import, dispense or deliver medicines.
Clinical decision: Only a qualified healthcare professional who has assessed the patient can decide whether a product, form or dose is appropriate.
CLEAR ANSWERS
Frequently asked questions about Nubeqa
01What is Nubeqa?＋
This directory record associates the brand name Nubeqa with the active ingredient Darolutamide. The brand and ingredient are shown for product identification only, not as treatment or dosing advice.
02Which Nubeqa strengths and packs are recorded?＋
The catalogue currently shows: 300 mg film-coated tablets · 112 tablets. Check the complete strength, dosage form and pack description against the prescription and medicine box.
03Who manufactures Nubeqa?＋
Catalogue records currently name: PARANOVA PACK A/S. This field may identify a manufacturer, marketing-authorisation holder, marketing company or supplier; confirm the exact role on the pack leaflet and official regulatory record.
04Do the listed options confirm stock or access?＋
No. A catalogue record does not confirm current stock, authorisation in a particular country, clinical suitability, import permission or access.
05What affects a possible estimated medicine cost for Nubeqa?＋
A possible cost depends on the exact strength, dosage form, pack, quantity, destination and regulatory jurisdiction. Any amount provided after an enquiry is an indicative medicine-cost estimate only, not a selling price for Nubeqa, payment request, stock guarantee or binding offer.
06Can I buy Nubeqa from this website?＋
No. This website does not sell, take payment for, prescribe, import, dispense or deliver medicines. The form creates an independent consultancy enquiry only.