SOCIAL QUESTIONS|health|pharmaceutical industry
- síneadh údaraithe margaíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- síneadh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- line extension | line-extension | extension | extension of a marketing authorisation
- en
- Definition "authorisation for a medicine [ IATE:1443220 ] for which the applicant either holds a marketing authorisation, or has submitted a marketing authorisation application, with changes:1. To the active substance(s) [ IATE:35093 ]:(i) replacement of the active substance(s) by a different salt/ester complex/derivative (with the same therapeutic moiety) where the efficacy/safety characteristics are not significantly different;(ii) replacement by a different isomer [ IATE:1684575 ], a different mixture of isomers, of a mixture by an isolated isomer (e.g. racemate [ IATE:1083643 ] by a single enantiomer [ IATE:1684578 ]) where the efficacy/safety characteristics are not significantly different;(iii) replacement of a biological substance or product of biotechnology with one of a slightly different molecular structure. Modification of the vector used to produce the antigen/source material, including a new master cell bank from a different source where the efficacy/safety characteristics are not significantly different;(iv) a new ligand [ IATE:1463918 ] or coupling mechanism for a radiopharmaceutical [ IATE:1442709 ];(v) change to the extraction solvent [ IATE:1099828 ] or the ratio of herbal drug [ IATE:2112449 ] to herbal drug preparation [ IATE:2112450 ] where the efficacy/safety characteristics are not significantly different.2. Changes to strength [ IATE:3518706 ], pharmaceutical form [" Reference COM-Term. Coord., based on:Regulation (EC) No 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State
- Comment "For parenteral administration, it is necessary to distinguish between intra-arterial, intravenous, intramuscular, subcutaneous and other routes. For administration to poultry, respiratory, oral and ocular (nebulisation) routes used for vaccination are considered to be equivalent routes of administration.Not to be confused with variation [ IATE:3510047 ]"