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CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and

On the basis of the scientific conclusions for paracetamol / tramadol the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing the active substance(s) paracetamol / tramadol 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 paracetamol / tramadol 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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