SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
| BONVIVA 150 MG F.C. TABLETS | 150 mg | Film-coated tablet · Oral use | 1 Blister | SAR 81.30 | NCE · Prescription | Atnahs Pharma UK Limited | Valid |
| BONDRONAT 2MG-2ML AMPOULE | 1 mg/ml | Injection · Intravenous use | 1 Ampoule | SAR 476.95 | NCE · Prescription | ROCHE DIAGNOSTICS | Withdrawn by MAH · Not Marketed |
| BONVIVA 3MG-3ML PREFILLED SYRINGES | 1 mg/ml | Injection · Intravenous use | 1 Pre-filled syringe | SAR 492.30 | NCE · Prescription | ROCHE & CO LTD | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HYPERPARATHYRODISM; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; OSTEOPOROSIS; SPINAL MUSCULAR ATROPHY - MAINTENANCE OF BONE HEALTH
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
| IBANDRONATE SODIUM | EQ 150MG BASE | tablet · oral | APOTEX INC | Prescription | 19 Mar 2012 |
| IBANDRONATE SODIUM | EQ 150MG BASE | tablet · oral | ORBION PHARMS | Prescription | 19 Mar 2012 |
| IBANDRONATE SODIUM | EQ 150MG BASE | tablet · oral | DR REDDYS LABS LTD | Prescription | 30 Apr 2012 |
| IBANDRONATE SODIUM | EQ 3MG BASE/3ML | injectable · intravenous | EUGIA PHARMA | Prescription | 19 Aug 2015 |
| IBANDRONATE SODIUM | EQ 3MG BASE/3ML | injectable · intravenous | APOTEX | Prescription | 16 Oct 2015 |
| IBANDRONATE SODIUM | EQ 3MG BASE/3ML | injectable · intravenous | ACCORD HLTHCARE | Prescription | 5 Feb 2016 |
| IBANDRONATE SODIUM | EQ 150MG BASE | tablet · oral | AUROBINDO PHARMA | Prescription | 11 Mar 2016 |
| IBANDRONATE SODIUM | EQ 150MG BASE | tablet · oral | MACLEODS PHARMS | Prescription | 31 Oct 2017 |
| BONIVA | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | HOFFMANN LA ROCHE | Discontinued | 16 May 2003 |
| BONIVA | EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · intravenous | ROCHE | Discontinued | 6 Jan 2006 |
| IBANDRONATE SODIUM | EQ 150MG BASE | tablet · oral | PHARMOBEDIENT | Discontinued | 19 Mar 2012 |
| IBANDRONATE SODIUM | EQ 150MG BASE | tablet · oral | WATSON LABS TEVA | Discontinued | 20 Mar 2012 |
| IBANDRONATE SODIUM | EQ 150MG BASE | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 15 Aug 2012 |
| IBANDRONATE SODIUM | EQ 3MG BASE/3ML | injectable · intravenous | SUN PHARM | Discontinued | 14 Feb 2014 |
| IBANDRONATE SODIUM | EQ 3MG BASE/3ML | injectable · intravenous | CHEMI SPA | Discontinued | 2 Sep 2014 |
| IBANDRONATE SODIUM | EQ 3MG BASE/3ML | injectable · intravenous | PHARMOBEDIENT | Discontinued | 2 Sep 2014 |
| IBANDRONATE SODIUM | EQ 3MG BASE/3ML | injectable · intravenous | AVET LIFESCIENCES | Discontinued | 2 Sep 2014 |
| IBANDRONATE SODIUM | EQ 3MG BASE/3ML | injectable · intravenous | NANG KUANG PHARM CO | Discontinued | 16 Jun 2021 |
EMA European Union — centrally authorised medicines
Bondronat Atnahs Pharma Netherlands B.V. · Authorised · authorised 25 Jun 1996 · ATC M05BA06
Therapeutic indication (EMA)
Bondronat is indicated for: prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases; treatment of tumour-induced hypercalcaemia with or without metastases.
Bonviva Atnahs Pharma Netherlands B.V. · Authorised · authorised 23 Feb 2004 · ATC M05BA06
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Ibandronic Acid Teva Teva Pharma B.V. · Authorised · authorised 17 Sep 2010 · ATC M05BA06
Therapeutic indication (EMA)
Ibandronic acid 50mg Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Ibandronic acid 150mg Treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Iasibon Pharmathen S.A. · Authorised · authorised 21 Jan 2011 · ATC M05BA06
Therapeutic indication (EMA)
Concentrate for solution for infusion Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases. Film-coated Tablets Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Ibandronic acid Accord Accord Healthcare S.L.U. · Authorised · authorised 18 Nov 2012 · ATC M05BA06
Therapeutic indication (EMA)
Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour induced hypercalcaemia with or without metastases. Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Ibandronic Acid Hexal Hexal AG · Application withdrawn · ATC M05BA06
Therapeutic indication (EMA)
Ibandronic Acid Hexal is indicated for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases.
Destara Roche Registration Ltd. · Withdrawn · authorised 25 Jun 1996 · ATC M05BA06
Therapeutic indication (EMA)
Treatment of tumour-induced hypercalcaemia with or without metastases.
Therapeutic indication (EMA)
Treatment of osteoporosis in post-menopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated. Efficacy on femoral-neck fractures has not been established.
Ibandronic Acid Sandoz Sandoz GmbH · Lapsed · authorised 26 Jul 2011 · ATC M05BA06
Therapeutic indication (EMA)
Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
| US NADAC | IBANDRONATE 3 MG/3 ML SYRINGE | $52.64778 | per ML | 23 Sep 2026 |
| US NADAC | IBANDRONATE SODIUM 150 MG TAB | $2.67507 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Ibandronic acid 150mg tablets | £16.60 | 1 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Ibandronic acid 3mg/3ml solution for injection pre-filled syringes | £65.40 | 1 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Ibandronic acid 50mg tablets | £39.80 | 28 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.
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.