Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
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Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for hydromorphone, the scientific conclusions are as follows: There were cumulatively 27 reports, describing 11 cases (during the reporting period there were 8 reports, describing 5 cases) of neonatal withdrawal syndrome reported with hydromorphone, while the use of hydromorphone is either not recommended or contra-indicated during pregnancy. From the presented data and a review of the literature in this PSUR, an association between maternal hydromorphone intake during pregnancy and neonatal drug withdrawal syndrome cannot be ruled out. Therefore, the PRAC considered that an update of the product information to add a warning of neonatal withdrawal syndrome associated with the prolonged use of hydromorphone is warranted. Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing hydromorphone, were warranted. The CMDh agrees with the scientific conclusions made by the PRAC.
Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for hydromorphone the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing hydromorphone is unchanged subject to the proposed changes to the product information. The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied. To the extent that additional medicinal products containing hydromorphone are currently authorised in the EU or are subject to future authorisation procedures in the EU, the CMDh recommends that such marketing authorisations are varied accordingly.
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Annex II Amendments to the product information of the nationally authorised medicinal product(s)
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Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through)
Summary of Product Characteristics •
Section 4.6
Prolonged use of hydromorphone during pregnancy can result in neonatal withdrawal syndrome. Package Leaflet •
Section 2
Pregnancy and breast-feeding Pregnancy Newborn babies may suffer withdrawal effects (such as high-pitched cry, jitteriness, fits, poor feeding and diarrhoea) if their mothers have taken hydromorphone for a long time during pregnancy.
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Annex III Timetable for the implementation of this position
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Timetable for the implementation of this position
Adoption of CMDh position:
September 2016 CMDh meeting
Transmission to National Competent Authorities of the translations of the annexes to the position:
29 October 2016
Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder):
Active substance: hydromorphone Regulatory outcome: variation
Oct 29, 2016 - Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through). Summary of Product Characteristics. â¢. Section 4.6. Prolonged use of hydromorphone during pregnancy can result in neonatal withdrawal syndrome. Package Leaflet.
Oct 29, 2016 - Taking into account the PRAC Assessment Report on the PSUR(s) for ... 3. Annex II. Amendments to the product information of the nationally ...
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