Disseminated - – intravascular coagulation Important Adverse Pregnancy – – potential Outcomes risks Male infertility – – Gastrointestinal - – perforation Pancreatitis - - Missing Use in patients with – – information hepatic impairment Use in patients with renal - – impairment Use in patients with - - cardiovascular impairment Use in the elderly - - Use in male patients - - Use in pregnant women - - Use in paediatric and – – adolescent population Recommendations There are no outstanding issues. Wording for conditions of registration Any changes to the sponsor has agreed should be included in a revised RMP and ASA. However, irrespective of whether or not they are included in the currently available version of the RMP document, the agreed changes become part of the risk management system. The suggested wording is: The EU-RMP version 4.0 (dated 15 July 2015; DLP 14 May 2015) and ASA version 1.0 (November 2015), submitted with application PM-2015-04001-1-4, must be implemented. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations: Quality No new quality data were provided with this submission. was no change to the registered formulation.
Disseminated intravascular coagulation – - Important potential risks Adverse Pregnancy Outcomes – – Male infertility – – Gastrointestinal perforation - – Pancreatitis - - Missing information Use in patients with hepatic impairment – – Use in patients with renal impairment - – Use in patients with cardiovascular impairment - - Use in the elderly - - Use in male patients - - Use in pregnant women - - Use in paediatric and adolescent population – – Recommendations There are no outstanding issues. Wording for conditions of registration Any changes to the sponsor has agreed should be included in a revised RMP and ASA. However, irrespective of whether or not they are included in the currently available version of the RMP document, the agreed changes become part of the risk management system. The suggested wording is: The EU-RMP version 4.0 (dated 15 July 2015; DLP 14 May 2015) and ASA version 1.0 (November 2015), submitted with application PM-2015-04001-1-4, must be implemented. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations: Quality No new quality data were provided with this submission. was no change to the registered formulation.