Sisepakend (väike vahetu sisepakend) peab sisaldama järgmist teavet: 1) ravimi nimi, mille järele tuleb märkida selle tugevus ja ravimvorm ning vajadusel märge, kas ravim on mõeldud imikutele, lastele või täiskasvanutele, ning kui ravimpreparaat sisaldab kuni kolme toimeainet, tuleb lisada ka toimeainete nimed; 2) manustamistee ja vajaduse korral manustamisviis; 3) selgelt väljendatud kõlblikkusaeg (kuu ja aasta, kujul kk/aaaa); 4) tootja partii number; 5) pakendi sisu kaalu, mahu või ühikute järgi.
The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging: (a) the name of the medicinal product followed by the common name where the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be included in the name of the medicinal product; (b) a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names; (c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product; ...
