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17/08/2019 alle 9:08 pm #28593

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Hence, the Committee is lioresal dosis intrathecal baclofen pump side effects intrathecal baclofen therapy pdf intrathecal of the view that an amendment to the section 4 . 4 is required to optimise the lioresal malaysia lioresal fk intrathecal baclofen safety lioresal gyógyszer lioresal nebenwirkungen warnings and precautions for use in the population with renal impairment .
Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information of medicinal products lioresal containing oral baclofen, were warranted .
The CMDh agrees with the scientific conclusions made by lioresal medicamento baclofen intrathecal solution lioresal sovradosaggio lioresal dosage forms the PRAC .
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 the opinion that the benefitrisk balance of the medicinal product(s) containing lioresal baclofen (oral) is unchanged subject to the proposed changes to the product information .
The lioresal 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 lioresal 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 authorisations are varied accordingly .

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