Is Nubeqa a prescription-only medicine in Saudi Arabia?

Yes. Nubeqa is a prescription-only medicine. It cannot lawfully be obtained without a valid prescription from a treating physician, and nothing on this page is an offer of sale to the public.

Which authority regulates Nubeqa in Saudi Arabia?

Saudi Food and Drug Authority (SFDA). Requirements change, so confirm the position that applies to your case directly with the authority before acting.

Which presentations of Nubeqa exist?

300 mg film-coated tablets (112/pack, one month at 600 mg BID). Which presentation and strength applies is decided by the treating physician according to the treatment protocol.

What handling conditions apply in transit?

Nubeqa travels in sealed original packaging away from heat and moisture, with batch numbers and expiry dates legible on the outer carton on arrival.

What documentation is typically required?

A valid prescription from the treating physician, naming the trade name, active ingredient, concentration and quantity — A medical report describing the diagnosis and the treatment plan — Proof of identity for the patient (and for the accompanying person, where relevant) — Travel details, where the medicine is being carried by a traveller — For a hospital or clinic: the establishment licence and the request of the responsible pharmacist

How can a Nubeqa carton be checked for authenticity?

Scan the GS1 DataMatrix on the carton and confirm that the GTIN, serial number, expiry date and batch number all decode correctly. Türkiye-sourced stock must be notified to the national İTS track-and-trace system. Check our authenticity guide and the WHO falsified medicine alert tracker before any dose is administered.

Do you publish a Nubeqa price for Saudi Arabia?

No. We publish no pricing for prescription medicines in the Gulf markets, and this page contains no price and no offer. Enquiries are handled on the basis of a valid prescription.

Why do published Nubeqa prices differ between countries?

Because each country sets prices through a different mechanism: external reference pricing, post-launch negotiation, cost-effectiveness assessment, or free pricing. Those mechanisms are explained in our article on how Turkish medicine pricing is set.

Can hospitals and oncology centres work with you?

Yes. We deal with licensed establishments through the responsible pharmacist, with a documentation pack covering certificate of origin, batch certificate of analysis, temperature records and batch traceability. See the hospital and procurement page.

What if Nubeqa is unavailable locally?

A national shortage is a common reason a prescribed medicine cannot be dispensed. Check the regulator's notices first, then discuss the lawful route with the treating physician — which may include a named-patient supply, where the authority permits it.

Hormonal Therapy

Nubeqa (darolutamide) in Saudi Arabia — Regulatory and Supply Information

Structurally distinct androgen receptor inhibitor for non-metastatic castration-resistant prostate cancer (nmCRPC, ARAMIS) and metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel + ADT (ARASENS). Standard dose 600 mg (2 × 300 mg tablets) twice daily with food.

Nubeqa (darolutamide) original manufacturer carton

Prescription-only medicine. No pricing is published on this page. Prescription-medicine pricing is not advertised to the public in this market.

This page is informational and is not an advertisement, a promotional communication, or medical advice. It does not offer any medicine for sale to the public. Treatment decisions belong to your treating physician.

What this medicine is

Active ingredient: darolutamide
Marketing authorisation holder: Bayer
Therapeutic class: Hormonal Therapy

Presentations and dosage forms

300 mg film-coated tablets (112/pack, one month at 600 mg BID)

Storage, cold chain and handling

Store below 30°C in original blister.

The regulatory route in Saudi Arabia

Medicines in Saudi Arabia are regulated by the Saudi Food and Drug Authority (SFDA). Every product described on this site is a prescription-only medicine, supplied against a valid prescription from a treating physician and dispensed through licensed channels. Nothing on this page is an offer to sell to the public.

Controlled medicines carried by travellers run through the SFDA's Controlled Drugs System (CDS) at cds.sfda.gov.sa. The SFDA published its Guideline for Clearance Permit of Controlled Drugs for Travelers on 14 August 2025, which sets out the electronic clearance request process.

Saudi Arabia updated its personal-import and prescription rules in December 2024. Confirm the current requirements directly with the SFDA before applying.

The SFDA publishes registration data for locally manufactured and non-local human medicines as open data. It does not publish a medicine price dataset, so any site presenting an "official SFDA price" for a specific product is not drawing on a published SFDA source. The SFDA also publishes drug circulars, withdrawal notices and current shortage information in Arabic — worth checking first, because a national shortage is the most common reason a prescribed medicine cannot be dispensed locally.

The process, step by step

Create an account on the Controlled Drugs System (CDS) at cds.sfda.gov.sa.
Submit an electronic clearance request containing the patient details and the trip details.
Upload the prescription, the medical report and proof of identity.
Specify the trade name, active ingredient, concentration and quantity of each medicine.
Track the request status, which is shown as Submitted, Completed, Rejected or Incomplete.

Documentation typically required

A valid prescription from the treating physician, naming the trade name, active ingredient, concentration and quantity
A medical report describing the diagnosis and the treatment plan
Proof of identity for the patient (and for the accompanying person, where relevant)
Travel details, where the medicine is being carried by a traveller
For a hospital or clinic: the establishment licence and the request of the responsible pharmacist

Official sources

Search terms for this medicine

The same molecule is searched under several names. All of the following refer to the same product:

Nubeqa
darolutamide
نوبيكا
دارولوتاميد
Nubeqa Saudi Arabia
نوبيكا المملكة العربية السعودية
darolutamide SFDA
Nubeqa prescription
نوبيكا وصفة طبية

Frequently asked questions

Prescription-based enquiry

If you hold a valid prescription from a treating physician in Saudi Arabia, you can send us the prescription details and we will reply with the regulatory and documentation position for that specific product. We do not publish pricing for Saudi Arabia and we do not sell to the public.

Send a prescription-based enquiry

Background reading

Related medicines

Medically reviewed by Pharmacy Remedy Pharmacovigilance & Compliance Desk · Last updated: 2026-07-29 · Saudi Food and Drug Authority

For healthcare professionals

Prescribers, hospital and specialty pharmacies, oncology centres and procurement departments: named patient supply, documentation and the sourcing workflow.