SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| AFINITOR 5 MG TABLET | 5 mg | Tablet · Oral use | 30 Blister | SAR 11047.60 | Generic · Prescription | NOVARTIS | Valid |
| Avrolem | 10 mg | Tablet · Oral use | 28 Blister | SAR 19247.40 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| Avrolem | 5 mg | Tablet · Oral use | 28 Blister | SAR 9623.70 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| Avrolem | 2.5 mg | Tablet · Oral use | 28 Blister | SAR 4811.85 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| CERTICAN 0.25MG TABLETS | 0.25 mg | Tablet · Oral use | 60 Blister | SAR 493.15 | NCE · Prescription | NOVARTIS | Valid |
| CERTICAN 0.75MG TABLETS | 0.75 mg | Tablet · Oral use | 60 Blister | SAR 1149.05 | NCE · Prescription | NOVARTIS | Valid |
| Evatoc | 10 mg | Tablet · Oral use | 30 Blister | SAR 17676.20 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| Evatoc | 5 mg | Tablet · Oral use | 30 Blister | SAR 8838.10 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| Evatoc | 2.5 mg | Tablet · Oral use | 30 Blister | SAR 4419.05 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| Everolimus BOS | 5 mg | Tablet · Oral use | 28 Blister | SAR 9142.50 | Generic · Prescription | Boston Oncology Arabia | Valid |
| Everolimus BOS | 10 mg | Tablet · Oral use | 28 Blister | SAR 17823.50 | Generic · Prescription | Boston Oncology Arabia | Valid |
| CERTICAN 0.1MG DISPERSIIBLE TABLETS | 0.1 mg | Orodispersible tablet · Oral use | 60 Blister | SAR 241.80 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
| CERTICAN 0.25MG DISPERSIBLE TABLETS | 0.25 mg | Orodispersible tablet · Oral use | 60 Blister | SAR 578.15 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
| CERTICAN 0.5MG TABLETS | 0.5 mg | Tablet · Oral use | 60 Blister | SAR 766.05 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
AUTOIMMUNE HEPATITIS; BRAIN CANCERS; BREAST CANCER MET.HORMONAL; HODGKIN'S LYMPHOMA; LYMPHOPLASMACYTIC LYMPHOMA; NEUROENDOCRINE TUMORS; PARATHYROID CANCER; RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC; THYROID CANCER-PAPILLARY, FOLLICULAR, HURTHLE CELL CARCINOMA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| AFINITOR | 5MG; 10MG; 2.5MG; 7.5MG | tablet · oral | NOVARTIS | Prescription | 30 Mar 2009 |
| ZORTRESS | 0.25MG; 0.5MG; 0.75MG; 1MG | tablet · oral | NOVARTIS | Prescription | 20 Apr 2010 |
| AFINITOR DISPERZ | 2MG; 3MG; 5MG | tablet, for suspension · oral | NOVARTIS PHARM | Prescription | 29 Aug 2012 |
| EVEROLIMUS | 0.25MG; 0.5MG; 0.75MG; 1MG | tablet · oral | HIKMA PHARMS | Prescription | 12 Apr 2018 |
| EVEROLIMUS | 2.5MG; 5MG; 7.5MG; 10MG | tablet · oral | TEVA PHARMS USA | Prescription | 9 Dec 2019 |
| EVEROLIMUS | 2.5MG; 5MG; 7.5MG; 10MG | tablet · oral | HIKMA PHARMS | Prescription | 8 Jun 2020 |
| EVEROLIMUS | 2.5MG; 5MG; 7.5MG; 10MG | tablet · oral | BIOCON PHARMA | Prescription | 11 Feb 2021 |
| EVEROLIMUS | 2.5MG; 5MG; 7.5MG; 10MG | tablet · oral | BRECKENRIDGE | Prescription | 5 Mar 2021 |
| EVEROLIMUS | 0.25MG; 0.5MG; 0.75MG; 1MG | tablet · oral | BRECKENRIDGE | Prescription | 20 May 2021 |
| EVEROLIMUS | 0.25MG; 0.5MG; 0.75MG; 1MG | tablet · oral | PH HEALTH | Prescription | 18 Oct 2021 |
| EVEROLIMUS | 0.25MG; 0.5MG; 0.75MG; 1MG | tablet · oral | ALKEM LABS LTD | Prescription | 26 Nov 2021 |
| EVEROLIMUS | 2MG; 3MG; 5MG | tablet, for suspension · oral | AMNEAL | Prescription | 10 Jan 2025 |
| EVEROLIMUS | 2MG; 3MG; 5MG | tablet, for suspension · oral | NATCO | Prescription | 28 Jan 2025 |
| EVEROLIMUS | 0.25MG; 0.5MG; 0.75MG; 1MG | tablet · oral | BIOCON PHARMA | Prescription | 9 Apr 2025 |
| EVEROLIMUS | 2.5MG; 5MG; 7.5MG; 10MG | tablet · oral | NEOCUBES PHARMA | Prescription | 30 Oct 2025 |
| EVEROLIMUS | 2MG; 3MG; 5MG | tablet, for suspension · oral | BIOCON PHARMA | Prescription | 9 Jan 2026 |
| EVEROLIMUS | 0.25MG; 0.5MG; 0.75MG; 1MG | tablet · oral | EUGIA PHARMA | Prescription | 25 Feb 2026 |
| EVEROLIMUS | 2.5MG; 5MG; 7.5MG; 10MG | tablet · oral | APOTEX | Prescription | 12 May 2026 |
| EVEROLIMUS | 0.25MG; 0.5MG; 0.75MG; 1MG | tablet · oral | PHARMAZONE | Prescription | 30 Jun 2026 |
| EVEROLIMUS | 2MG; 3MG; 5MG | tablet, for suspension · oral | NOVITIUM PHARMA | Prescription | 21 Sep 2026 |
| EVEROLIMUS | 2MG; 3MG; 5MG | tablet, for suspension · oral | MYLAN | Discontinued | 19 Apr 2019 |
| EVEROLIMUS | 2.5MG; 5MG; 7.5MG; 10MG | tablet · oral | PH HEALTH | Discontinued | 9 Dec 2019 |
| EVEROLIMUS | 2.5MG; 5MG; 7.5MG; 10MG | tablet · oral | MYLAN | Discontinued | 8 Jun 2020 |
EMA European Union — centrally authorised medicines
Afinitor Novartis Europharm Limited · Authorised · authorised 2 Aug 2009 · ATC L01XE10
Therapeutic indication (EMA)
Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. Renal-cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Votubia Novartis Europharm Limited · Authorised · authorised 2 Sep 2011 · ATC L01XE10
Therapeutic indication (EMA)
Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease?related symptoms, has not been demonstrated.
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | EVEROLIMUS 0.25 MG TABLET | $1.78523 | per EA | 23 Sep 2026 |
| US NADAC | EVEROLIMUS 0.5 MG TABLET | $3.52462 | per EA | 30 Sep 2026 |
| US NADAC | EVEROLIMUS 0.75 MG TABLET | $4.18252 | per EA | 23 Sep 2026 |
| US NADAC | EVEROLIMUS 1 MG TABLET | $5.25295 | per EA | 30 Sep 2026 |
| US NADAC | EVEROLIMUS 10 MG TABLET | $26.32425 | per EA | 30 Sep 2026 |
| US NADAC | EVEROLIMUS 5 MG TABLET | $14.77078 | per EA | 30 Sep 2026 |
| NHS Drug Tariff | Everolimus 250microgram tablets | £148.50 | 60 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Everolimus 750microgram tablets | £445.50 | 60 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 8.2.2. Targeted therapies · complementary
Other specified gliomas of brain
Oral > Solid > dispersible tablet: 2 mg; 3 mg; 5 mg | Oral > Solid > tablet: 2.5 mg; 5 mg; 7.5 mg; 10 mg
Safety signals and safety-related labeling changes
- US FDA 16 Sep 2026 ZORTRESS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 1 Jun 2026 AFINITOR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 1 Jun 2026 AFINITOR DISPERZ — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 12 Feb 2015 PRAC signal: Lymphoedema
Action for MAH: update of the product information: No
All safety entries for everolimus →
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.