Section 7: Marketing Authorisation Holder changed to: Kyowa Kirin Holdings B.V, Bloemlaan 2, 2132NP Hoofddorp, the Netherlands; +31(0)237200822

Section 8: Marketing Authorisation Number updated to: PA2288/003/002

Section 10: Date of revision of the text updated to January 2019

Section 1- ® sign on Xomolix has been removed.$0$0$0Section 2- The sentence 'Excipient: sodium < 23 mg per ml' has been updated to ' Excipient with known effect: sodium  < 23 mg per ml (see section 4.4 for further details) '. $0$0$0$0$0Section 4.1- 'Xomolix is indicated in:' has been added as the opening statement.$0$0$0$0$0Section 4.2- Header for method of administration moved toward the end of the section.$0$0                  - The sentence ' For instructions on dilution of the product before administration, see section 6.6' has been updated to 'For instructions on dilution of the medicinal product                       before administration, see section 6.6.'$0$0$0$0$0Section 4.3- The sentence ' Droperidol is contraindicated in patients with: $0$0                                            ·   Hypersensitivity to droperidol or to any of the excipients;'$0$0                     updated to ' Xomolix is contraindicated in patients with:$0$0         ·   Hypersensitivity to the active substance or to any of the excipients listed in section 6.1'$0$0$0$0$0Section 4.5- Specific examples of medicinal products that interact with Xomolix 2.5mg/ml solution for injection have been removed. $0$0$0$0$0Section 4.6- Fertility section has been moved to bottom of section.$0$0$0$0$0Section 4.7- In the first sentence, the word 'Droperidol' changed to 'Xomolix'$0$0$0$0$0Section 4.8- 'Psychomotor hyperactivity' and 'coma' have been removed.$0$0                  - 'Neonatal drug withdrawal syndrome' has been added.$0$0                  - Under reporting of suspected adverse reactions, HPRA contact details have been updated.$0$0$0$0$0Section 5.1- The sentence 'Droperidol's inhibitory action....and treatment of postoperative nausea and vomiting and/or induced by opioid analgesics' has been updated to$0$0                     'Droperidol's inhibitory action....and treatment of postoperative nausea and vomiting and/or nausea and vomiting induced by opioid analgesics'$0$0$0$0$0Section 5.2- Under section distribution, the sentence ' Following intraveneous administration, plasma concentrations fall rapidly during the first 15 minutes.' has been updated to$0$0                    ' Following intraveneous administration, plasma concentrations fall rapidly during the first 15 minutes; this is metabolism independent, redistribution of the drug.'$0$0                  - Under section Paediatric population, typo error ' 4.66  2.88 ml/kg*min ' has been corrected to ' 4.66 ± 2.88 ml/kg*min ' $0$0$0$0$0Section 6.4- The sentence ' Store in the original package' has been updated to 'Store in the original package in order to protect from light'$0$0$0$0$0Section 6.6- The sentence' Any unused product or waste material should be disposed of in accordance with local requirements' has been updated to                                                                           'Any unused medicinal product or waste material should be disposed of in accordance with local requirements.' $0$0$0$0$0Section 10- Date of revision has been updated from September 2016 to February 2018.$0$0$0$0$0$0$0$0               $0$0$0

In section 4.8 (undesirable effects)- contact details for how to report suspected adverse reactions have been added.$0$0$0$0In section 10, the date of revision of the text has been changed from May 2016 to Sep 2016.$0

In section 7: Change name of Marketing Authorisation Holder from ProStrakan Ltd. to Kyowa Kirin Ltd.
In section 10: Change date of revision of the text from March 2014 to May 2016.

None provided