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Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for baclofen (oral) the CMDh is of lioresal the opinion that the benefitrisk balance of the medicinal product(s) containing baclofen (oral) is unchanged subject to the proposed changes to the product information .
The lioresal laboratorio intrathecal baclofen quality of life lioresal adalah obat untuk baclofen 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 baclofen (oral) are lioresal 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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