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Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for baclofen (oral), the scientific conclusions are as follows: Further to a cumulative review of all case reports of central sleep apnoea syndrome with baclofen, the PRAC concluded that the lioresal injection intrathecal baclofen for spastic hypertonia from stroke lioresal and oxycodone provided dataset supports evidence of a causal relationship with baclofen .
8 of the SmPC lioresal are warranted with the inclusion of this ADR with frequency “unknown”, accompanied by an explanatory footnote . Whilst acknowledging that alcohol is a risk factor lioresal for “sleep apnoea syndrome”, the Committee agreed that amendments to section 4 .

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