Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 36, Status: Authorised

Aclasta RSS Authorised This medicine is authorised for use in the European Union zoledronic acid Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assessment report (EPAR) for Aclasta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aclasta. Expand section Collapse section What is Aclasta? Aclasta is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid. What is Aclasta used for? Aclasta is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men. It is used in patients who are at risk of fractures (broken bones) including those who have recently broken their hip in a minor trauma such as a fall, and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid). Aclasta is also used to treat Paget’s disease of the bone in adults. This is a disease where the normal process of bone growth is changed. The medicine can only be obtained with a prescription. How is Aclasta used? Aclasta is given as an infusion lasting at least 15 minutes. This can be repeated once a year in patients being treated for osteoporosis. Patients who have broken their hip should not receive Aclasta any earlier than two weeks after the operation to repair the fracture. For Paget’s disease, only one infusion of Aclasta is usually given, but additional infusions can be considered if the patient’s disease comes back. The effect of each infusion lasts for a year or more. Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium. Using paracetamol or ibuprofen (anti?inflammatory medicines) shortly after Aclasta can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion. In the treatment of Paget’s disease of the bone, Aclasta must only be used by a doctor who has experience in the treatment of the disease. Aclasta should not be used in patients with severe kidney problems. How does Aclasta work? Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to fracture. In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall. Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment. In Paget’s disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal. The active substance in Aclasta, zoledronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss in osteoporosis and less disease activity in Paget’s disease. Zoledronic acid has also been authorised in the European Union (EU) as Zometa since March 2001 for the prevention of bone complications in patients with cancer that is affecting the bone, and for the treatment of hypercalcaemia (high blood calcium levels) caused by tumours. How has Aclasta been studied? Because zoledronic acid has been authorised in the EU as Zometa for a number of years, the company presented the results of some studies carried out with Zometa, which were taken into account when assessing Aclasta. For osteoporosis, Aclasta has been studied in three main studies. The first compared Aclasta with placebo (a dummy treatment) in almost 8,000 elderly women with osteoporosis, looking at the number of fractures in the spine and the hip over three years. The second study compared Aclasta with placebo in 2,127 men and women with osteoporosis who had recently broken their hip, and looked at the number of fractures over up to five years. The third compared one infusion of Aclasta with daily treatment with risedronate (another bisphosphonate) in 833 men and women with osteoporosis caused by glucocorticoids, and looked at the change in the density of the bones in the spine over a year. In these studies, the patients could take other medicines for osteoporosis, but not other bisphosphonates. For Paget’s disease, Aclasta has been compared with risedronate in a total of 357 adults in two studies lasting six months. The patients received one infusion of Aclasta or they took risedronate once a day for two months. The main measure of effectiveness was the number of patients who responded to treatment, defined as blood levels of serum alkaline phosphatase (an enzyme involved in the breakdown of bone) returning to normal or falling at least three quarters of the way back to normal. What benefit has Aclasta shown during the studies? In osteoporosis, Aclasta was more effective than the comparator medicines. In the study of elderly women, the risk of fractures in the spine was reduced by 70% in patients taking Aclasta (without any other medicines for osteoporosis) over three years when compared with those taking placebo. There was a 41% risk reduction in hip fractures, when comparing all women taking Aclasta (with or without other osteoporosis medicines) with those taking placebo. In the study of men and women who had broken their hip, 9% of the patients receiving Aclasta had a fracture (92 out of 1,065), compared with 13% of the patients receiving placebo (139 out of 1,062). Finally, Aclasta was more effective than risedronate at increasing spine bone density over a year’s treatment in patients taking glucocorticoids. In Paget’s disease, Aclasta was more effective than risedronate. After six months, around 96% of patients had responded to treatment in the two studies, compared with around 74% of the patients who received risedronate. What is the risk associated with Aclasta? Most side effects with Aclasta tend to occur within the first three days after infusion, becoming less common with repeated infusions. The most common side effect with Aclasta (seen in more than 1 patient in 10) is fever. Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported rarely (seen in between 1 and 10 patients in 10,000). For the full list of all side effects reported with Aclasta, see the package leaflet. Aclasta must not be used in people who are hypersensitive (allergic) to zoledronic acid, to other bisphosphonates or to any of the other ingredients. Aclasta must not be used in patients with severe kidney problems, hypocalcaemia (low blood calcium levels), or in pregnant or breastfeeding women. Why has Aclasta been approved? The CHMP decided that Aclasta’s benefits are greater than its risks and recommended that it be given marketing authorisation. What measures are being taken to ensure the safe and effective use of Aclasta? A risk management plan has been developed to ensure that Aclasta is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aclasta, including the appropriate precautions to be followed by healthcare professionals and patients. The company that makes Aclasta will provide educational packs in each Member State for doctors who prescribe Aclasta for osteoporosis, reminding them how the medicine should be used. It will also provide an information pack for patients to explain the medicine’s side effects, remind them of the need for adequate calcium and vitamin D supplementation, and when patients should contact their doctor. Patients will also be provided with a reminder card on the risk of osteonecrosis of the jaw, instructing patients to contact their doctor if they experience symptoms. Other information about Aclasta The European Commission granted a marketing authorisation valid throughout the EU for Aclasta on 15 April 2005. For more information about treatment with Aclasta, read the package leaflet (also part of the EPAR). Aclasta : EPAR - Summary for the public English (EN) (85.67 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View Other languages (22) български (BG) (116.88 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View español (ES) (88.01 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View čeština (CS) (116.59 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View dansk (DA) (86.36 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View Deutsch (DE) (89.48 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View eesti keel (ET) (85.11 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View ελληνικά (EL) (121.43 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View français (FR) (88.99 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View hrvatski (HR) (109.97 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View italiano (IT) (87.1 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View latviešu valoda (LV) (111.78 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View lietuvių kalba (LT) (111.91 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View magyar (HU) (110.49 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View Malti (MT) (119.71 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View Nederlands (NL) (87.5 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View polski (PL) (115.14 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View português (PT) (110.33 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View română (RO) (112 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View slovenčina (SK) (114.22 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View slovenščina (SL) (106.87 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View Suomi (FI) (85.62 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View svenska (SV) (85.62 KB - PDF) First published: 08/07/2009 Last updated: 28/07/2015 View Aclasta : EPAR - Risk-management-plan English (EN) (627.49 KB - PDF) First published: 04/03/2024 View Product information Aclasta : EPAR - Product Information English (EN) (410.31 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View Other languages (24) български (BG) (475.57 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View español (ES) (495.03 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View čeština (CS) (465.55 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View dansk (DA) (417.99 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View Deutsch (DE) (451.09 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View eesti keel (ET) (407.15 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View ελληνικά (EL) (503.88 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View français (FR) (473.55 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View hrvatski (HR) (444.61 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View íslenska (IS) (417.08 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View italiano (IT) (460.37 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View latviešu valoda (LV) (507.87 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View lietuvių kalba (LT) (471.77 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View magyar (HU) (513.69 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View Malti (MT) (501.89 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View Nederlands (NL) (425.45 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View norsk (NO) (413.06 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View polski (PL) (475.31 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View português (PT) (282.26 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View română (RO) (468.07 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View slovenčina (SK) (467.65 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View slovenščina (SL) (456.53 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View Suomi (FI) (419.43 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View svenska (SV) (433.51 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View Latest procedure affecting product information: N/0000341352 16/04/2026 This medicine’s product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Aclasta : EPAR - All Authorised presentations English (EN) (60.3 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View Other languages (21) български (BG) (78.4 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View español (ES) (58.69 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View čeština (CS) (81.06 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View dansk (DA) (61.02 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View Deutsch (DE) (63.37 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View eesti keel (ET) (58.92 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View ελληνικά (EL) (75.6 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View français (FR) (59.79 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View italiano (IT) (57.35 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View latviešu valoda (LV) (82.09 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View lietuvių kalba (LT) (80.78 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View magyar (HU) (80.24 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View Malti (MT) (81.31 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View Nederlands (NL) (59.7 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View polski (PL) (83.33 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View português (PT) (58.23 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View română (RO) (76.99 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View slovenčina (SK) (81.34 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View slovenščina (SL) (60.48 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View Suomi (FI) (57.86 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View svenska (SV) (59.87 KB - PDF) First published: 18/04/2006 Last updated: 18/04/2006 View Aclasta : EPAR - Conditions imposed on member states for safe and effective use - Annex IV English (EN) (148.09 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View Other languages (23) български (BG) (155.14 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View español (ES) (146.13 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View čeština (CS) (164.81 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View dansk (DA) (146.33 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View Deutsch (DE) (152.78 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View eesti keel (ET) (145.14 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View ελληνικά (EL) (152.88 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View français (FR) (153.38 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View íslenska (IS) (147.96 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View italiano (IT) (147.92 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View latviešu valoda (LV) (150.22 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View lietuvių kalba (LT) (152 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View magyar (HU) (150.67 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View Malti (MT) (155.33 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View Nederlands (NL) (148.14 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View norsk (NO) (146.25 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View polski (PL) (152.33 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View português (PT) (148.11 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View română (RO) (150.56 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View slovenčina (SK) (154.61 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View slovenščina (SL) (147.85 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View Suomi (FI) (143.68 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View svenska (SV) (144.88 KB - PDF) First published: 08/07/2009 Last updated: 07/06/2012 View Product details Name of medicine Aclasta Active substance zoledronic acid International non-proprietary name (INN) or common name zoledronic acid Therapeutic area (MeSH) Osteoporosis Osteitis Deformans Osteoporosis, Postmenopausal Anatomical therapeutic chemical (ATC) code M05BA08 Pharmacotherapeutic group Drugs for treatment of bone diseases Therapeutic indication Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture. Treatment of Paget's disease of the bone. Authorisation details EMA product number EMEA/H/C/000595 Marketing authorisation holder Sandoz Pharmaceuticals d.d. Verovškova ulica 57 1000 Ljubljana SLOVENIA Marketing authorisation issued 15/04/2005 Revision 36 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Aclasta : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (145.8 KB - PDF) First published: 20/04/2026 View Aclasta : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (242.99 KB - PDF) First published: 08/07/2009 Last updated: 20/04/2026 View Aclasta-H-C-595-P46-036 : EPAR - Assessment Report Adopted Reference Number: EMA/873947/2018 English (EN) (373.13 KB - PDF) First published: 18/12/2018 View Aclasta-H-C-PSUSA-00009334-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation Reference Number: EMA/CHMP/373034/2015 English (EN) (61.59 KB - PDF) First published: 28/07/2015 Last updated: 28/07/2015 View Aclasta-H-C-595-PSUV-0047 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation Reference Number: EMA/CHMP/753938/2014 English (EN) (66.39 KB - PDF) First published: 05/12/2014 Last updated: 05/12/2014 View CHMP post-authorisation summary of positive opinion for Aclasta Adopted Reference Number: EMA/CHMP/966950/2011 English (EN) (46.57 KB - PDF) First published: 16/12/2011 Last updated: 16/12/2011 View Aclasta-H-C-595-A20-0026 : EPAR - Assessment Report - Article 20 Adopted Reference Number: EMA/543438/2011 English (EN) (123.56 KB - PDF) First published: 13/09/2011 Last updated: 13/09/2011 View Aclasta-H-C-595-II-0017 : EPAR - Assessment Report - Variation Reference Number: EMEA/CHMP/358213/2009 English (EN) (363.4 KB - PDF) First published: 08/07/2009 Last updated: 08/07/2009 View Aclasta-H-C-595-II-0016 : EPAR - Assessment Report - Variation Reference Number: EMEA/CHMP/483357/2008 English (EN) (684.77 KB - PDF) First published: 21/10/2008 Last updated: 21/10/2008 View CHMP post-authorisation summary of positive opinion for Aclasta on 24 July 2008 Adopted Reference Number: EMEA/CHMP/391587/2008 English (EN) (30.95 KB - PDF) First published: 24/07/2008 Last updated: 24/07/2008 View Aclasta-H-C-595-II-10 : EPAR - Scientific Discussion - Variation Adopted English (EN) (296.41 KB - PDF) First published: 23/10/2007 Last updated: 23/10/2007 View Initial marketing authorisation documents Aclasta : EPAR - Scientific Discussion English (EN) (218.27 KB - PDF) First published: 03/04/2006 Last updated: 03/04/2006 View Aclasta : EPAR - Procedural steps taken before authorisation English (EN) (17.84 KB - PDF) First published: 03/04/2006 Last updated: 03/04/2006 View News on Aclasta Further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine 27/03/2015 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2015 27/03/2015 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2015 13/03/2015 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 2012 17/02/2012 European Medicines Agency concludes class review of bisphosphonates and atypical fractures 15/04/2011 More information on Aclasta EMEA-000057-PIP01-07-M07 - paediatric investigation plan Topics Medicines This page was last updated on 20/04/2026 Share this page