WebISENTRESS and ISENTRESS HD can be administered with or without food (2.1). Do not … WebSupplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right. They apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities.

European Medicines Agency

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Summary of product characteristics - fimea englanti

WebInterferon alfa-2b, recombinant For Injection WARNING Alpha interferons, including INTRON®A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. WebFor common European procedures (CP, MRP, DCP), the Finnish and Swedish SPC must be a translation of the English common SPC. Fimea publishes the summaries of product characteristics for products that have been granted marketing authorisation through the national procedure, mutual recognition procedure or decentralised procedure on its website. Webparticular preparation, all of which are detailed in the Summary of Product Characteristics (SPC). Extemporaneously prepared medicines are unlicensed medicines and are not subject to these regulatory safeguards. Therefore neither prescribers nor pharmacists can make the same assumptions of quality, safety and efficacy gmc buick dealerships in michigan