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QRD Human PI Annotated Template v10.2 rev1
www.ema.europa.euSUMMARY OF PRODUCT CHARACTERISTICS [NOTE: the following are those items of information required by Article 11 of Directive 2001/83/EC and current practice in the centralised procedure. In the case of advanced therapy medicinal products, these items are listed in Annex II of Regulation (EC) 1394/2007.
QRD Human PI Annotated Template v10.2 rev1 - highlighted
www.ema.europa.eu<For instructions on <reconstitution> <dilution> of the medicinal product before administration, see section <6.6> <and> <12>.> 4.3 Contraindications <Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 <or {name of the residue(s)}>.> 4.4 Special warnings and precautions for use