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Regulation (EU) No 1238/2010 ANNEX II

Regulation (EU) No 1238/2010 ANNEX II

ANNEX IISupplementary provisions

ANNEX II List of prefixes and suffixes which, in combination with the INNs of Annex 3 to Annex I to Regulation (EEC) No 2658/87, describe the salts, esters or hydrates of INNs; these salts, esters and hydrates are free of duty, on condition that they are classifiable in the same six-digit HS subheading as the corresponding INN The references to ‘International Nonproprietary Names (INN) for pharmaceutical substances, names for radicals and groups, comprehensive list 2004’ are replaced by ‘International Nonproprietary Names (INN) for pharmaceutical substances, names for radicals, groups and others, comprehensive list 2007’. The following prefixes or suffixes are added to the list included in Annex 4 to Annex I to Regulation (EEC) No 2658/87: Preferred prefix or suffix Synonym Systematic name when different alanetil (INNRG)   [(S)-1-ethoxy-1-oxo-propan-2-yl]amino (INNCN) alaninate (INNRG)   L-alaninate (INNCN) alapivoxil (INNRG)   L-alanyl, [(2,2-dimethylpropanoyl)oxy]metyl (INNCN) aldifitox (INNRG)   (4-iminobutane-1,4-diyl)sulfanediyl[(3RS)-2,5-dioxopyrrolidine-1,3-diyl]-1,3-phenylenecarbonyl and forming an N-benzoyl derivative of a primary amine group of diphtheria [550-L-phenylalanine]toxin from Corynebacterium diphtheriae -(26-560)-peptide (INNCN) besudotox (INNRG)   L-lysyl-L-alanyl-L-serylglycylglycine (linker) fusion protein with des-(365-380)-[Asn 364 ,Val 407 ,Ser 515 ,Gln 590 ,Gln 606 ,Arg 613 ]exotoxin A ( Pseudomonas aeruginosa )-(251-613)-peptide (toxin with region IA and first 16 residues of region IB deleted) (INNCN) ceribate (INNRG)   rac-2,3-dihydroxypropyl carbonate (ester) (INNCN) cipecilate (INNRG)   cyclohexanecarboxylate (ester), cyclopropanecarboxylate (ester) (INNCN) dalanated (INNRG)   des-B30-alanine (INNCN) enacarbil (INNRG)   {rac-1-[(2-methylpropanoyl)oxy]ethoxy}carbonyl (INNCN) estafenatox (INNRG)   glycylglycyl-L-proline (linker) fusion protein with enterotoxin type A ( Staphylococcus aureus )-(1-33)-peptidyl-L-seryl[Ser 36 ,Ser 37 ,Glu 38 ,Lys 39 ,Ala 41 ,Thr 46 ,Thr 71 ,Ala 72 ,Ser 75 ,Glu 76 ,Glu 78 ,Ser 80 ,Ser 81 ,Thr 214 ,Ser 217 ,Thr 219 ,Ser 220 ,Ser 222 ,Ser 224 ]enterotoxin type E ( Staphylococcus aureus )-(32-230)-peptide (synthetic superantigen SEA/E-120) (INNCN) etexilate (INNRG)   ethyl, (hexyloxy)carbonyl fosamil (INNRG)   phosphono (INNCN) glucuronide (INNRG)   β-D-glucopyranosiduronic acid [oside] (INNCN) medocaril (INNRG)   [(5-methyl-2-oxo-1,3-dioxol-4-yl)methoxy]carbonyl (INNCN) paptox (INNRG)   protein PAP ( Phytolacca americana antiviral) (INNCN) placarbil (INNRG)   (R)-2-methyl-1-[(2-methylpropanoyl)oxy]propoxy}carbonyl) (INNCN) The systematic name of the following prefix or suffix is amended as follows: Preferred prefix or suffix Synonym Systematic name when different aritox (INNRG)   ricin A chain (INNCN)

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Other provisions in Regulation (EU) No 1238/2010

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CitationANNEX II of Regulation (EU) No 1238/2010 (LawPlayer, data as of 2026-07-04)

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