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Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of baclofen medication classification intrathecal baclofen withdrawal syndrome a case report lioresal the scientific conclusions for baclofen (oral) the CMDh is of 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 CMDh reaches the lioresal ahumada lioresal adalah obat untuk baclofen medication classification intrathecal baclofen 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 currently authorised in the EU or are subject to future authorisation procedures in the EU, the CMDh recommends that such marketing lioresal authorisations are varied accordingly .
Amendments to the product information of the nationally authorised medicinal product(s) Amendments to be included in intrathecal baclofen pump surgery lioresal side effects lioresal price lioresal za sta je lioresal the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through) Summary of Product Characteristics A warning should be revised as follows: Abrupt withdrawal: “Treatment should always, (unless serious adverse effects occur), be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks .

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