NeLM news service
EMEA approves additional contraindications for ibandronic acid preparations

Source: EMEA

Date published: 11/01/2010 15:54

Summary
by: Nicola Pocock

The Committee for Medicinal Products for Human Use (CHMP) of the EMEA has recommended the adoption of the following contraindications for Bondronat® (ibandronic acid):

 

• “Hypocalcaemia” - for both the 50mg tablets and the concentrate for solution for infusion
• “Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia” - for the 50mg tablets only
• “Inability to stand or sit upright for at least 60 minutes” - for the 50mg tablets only

 

The following contraindications have been recommended for Bonviva® and Bondenza® (both ibandronic acid tablets):

 

• “Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia”
• “Inability to stand or sit upright for at least 60 minutes”
(Hypocalcaemia is already listed as a contra-indication to the use of these two products)

 

Detailed conditions for the use of these products will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

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