Annex 10 of Pharmacovigilance Procedure (subitem 2 of item 3 of chapter 1 of section VI) FREQUENCY OF SUBMITTING periodic safety update reports for medicinal products, vaccines, tuberculin* by INN of API or combination of API INN of API or combination of API PSUR Data lock Submission Publication submission point date date frequency 1 2 3 4 5 125i-human serum albumin 13 years 15/12/2025 15/03/2026 5 fluorouracil (i.v. application) 3 years 16/12/2017 16/03/2018 5-aminolevulinic acid (glioma) 3 years 07/03/2018 05/06/2018 5-aminolevulinic acid (keratosis) 1 year 14/06/2018 23/08/2018 abacavir 3 years 31/12/2019 31/03/2020 abacavir, lamivudine 3 years 31/12/2019 31/03/2020 abacavir, lamivudine, zidovudine 3 years 31/12/2019 31/03/2020 abies oil, camphor, salicylic acid, venom viper 13 years 31/12/2018 31/03/2019 abies oil, dauci sativi fluidum, origani fluidum, 13 years 31/12/2018 31/03/2019 peppermint oil, strobili lupuli fluidum abiraterone 1 year 27/04/2018 06/07/2018 abrus precatorius, acacia catechu, adhatoda 13 years 31/12/2018 31/03/2019 vasica, alpinia galanga, curcuma, emblica oficinale, foeniculum, glycyrrhiza, menthol, ocimum sanctum, piper longum, piper nigrum, terminalia chebula, terminalia belerica, zingiber officinale abrus precatorius, aconitum napellus, 13 years 31/12/2018 31/03/2019 belladonna, calendula, chelidonium majus, viburnum opulus absinthii, achillea, althaea, calami, calendula, 5 years 31/12/2018 31/03/2019 glycyrrhiza, helichrysum arenarium, hypericum, matricaria, mentha piperita, salvia officinalis, sambucus, sophora japonica, rosa, urtica absinthii, achillea, anethi, calami, leuzeae 13 years 31/12/2018 31/03/2019 carthamoide, menthae piperitae, menyanthidis, tiliae, quercus absinthii, angelicae, anserinae, cnici ben, 5 years 31/12/2018 31/03/2019 glycyrrhiza, hypericum, matricariae absinthii, calami rhizomata, helishrysi arenarii, 5 years 31/12/2018 31/03/2019 hypericum, menthae piperitae, quercus cortex, potentilla, taraxaci radices, zeae maydis styli cum stigmatis acacia arabica, aegle marmelos, anacyclus 5 years 31/12/2018 31/03/2019 pyrethrum, argyreia speciosa, asparagus racemosus, bombax malabaricum, clerodendrum phlomidis, crocus sativus, dashamoola stereospermum suaveolens, desmodium gangenticum gmeline arborea, hibiscus abelmoschus, hydrargyrum sulfidum ruber, ipomoea digitata, minerale pix purum, mucuna pruriens, orchis mascula, oroxylum indicum, plumbum, sida cordifolia, solanum anguivi, solanium xanthocarpum stannum, strychnos nux-vomica, piper betle, piper nigrum, tinospora cordifolia, tribulus terrestris, uraria picta, withania somnifera, zincum acarbose 3 years 31/03/2018 29/06/2018 aceclofenac 3 years 31/03/2020 29/06/2020 acenocoumarol 9 years 01/07/2021 29/09/2021 acetazolamide 16 years 01/01/2028 31/03/2028 acetic acid, amylmetacresolum, sodium 13 years 31/12/2018 31/03/2019 ascorbate, spiritus dichlorobenzylicus acetic acid, azotic acid, oxalic acid dyhydrat, 13 years 31/12/2018 31/03/2019 zink nitrate acetone, boric acid, fuchsin, phenol, resorcin 13 years 01/01/2025 01/04/2025 acetylaminonitropropoxybenzene (falimint) 5 years 01/01/2020 31/03/2020 acetylated wool alcohols, liquid paraffin 13 years 01/01/2025 01/04/2025 acetylcysteine 3 years 13/09/2018 12/12/2018 acetylcysteine, ambroxol 3 years 13/02/2020 14/05/2020 acetylcysteine, acetyl tyrosine, calcium chloride, 13 years 01/01/2025 01/04/2025 glycine, L-alanine, L-arginine, L-aspartic acid, L-glutamic acid, L-histidine, L-isoleucine, L- leucine, L-malic acid, L-methionine, L- phenylalanine, L-proline, L-serine, L-valine, L- threonine, L-tryptophan, lysine acetate, magnesium chloride, ornithine hydrochloride, potassium chloride, sodium acetate, sodium hydroxide, sodium chloride acetylcysteine, tuaminoheptan sulfate 13 years 01/03/2025 30/05/2025 acetylsalicylic acid 3 years 01/02/2019 02/05/2019 acetylsalicylic acid, aminoacetic acid 3 years 01/02/2019 02/05/2019 acetylsalicylic acid, ascorbic acid 23 years 04/02/2035 05/05/2035 acetylsalicylic acid, bisoprolol 3 years 05/11/2018 13/02/2019 acetylsalicylic acid, caffeine, paracetamol 13 years 24/10/2025 22/01/2026 acetylsalicylic acid, chlorphenamine, 13 years 01/01/2025 01/04/2025 phenylephrine acetylsalicylic acid, citric acid, sodium hydrogen 13 years 01/01/2025 01/04/2025 carbonate acetylsalicylic acid, clopidogrel / clopidogrel 3 years 17/11/2019 15/02/2020 acetylsalicylic acid, dipyridamole 13 years 05/04/2025 04/07/2025 acetylsalicylic acid, glycine 18 years 01/01/2030 01/04/2030 acetylsalicylic acid, magnesium hydroxide 13 years 01/01/2025 01/04/2025 achillea 13 years 31/12/2018 31/03/2019 achillea, aconitum napellus, arnica montana, 13 years 31/12/2018 31/03/2019 atropa belladonna, bellis perennis, calendula officinalis, echinacea, echinacea purpurea, hamamelis virginiana, hepar sulfuris, hypericum perforatum, matricaria recutita, mercurius solubilis hahnemanni, symphytum achillea, acorus calamus, anethum graveolens, 13 years 31/12/2018 31/03/2019 artemisia, mentha piperita, menyanthes trifoliata, quercus robur, rhaponticum carthamoides, tilia cordata achillea, acorus, calendula, capsella bursa- 5 years 31/12/2018 31/03/2019 pastoris, chamomilla, chelidonium, hypericum, origanum, vinca minor achillea, althaea, equisetum, juglans regia, 13 years 31/12/2018 31/03/2019 matricaria, quercus, taraxacum achillea, arctostaphylos, betula, ononis spinosa, 13 years 31/12/2018 31/03/2019 petroselinum, polygonum, sambucus nigra, urtica achillea, belladonnae, benzocaine, cytisus 13 years 31/12/2018 31/03/2019 scoparium, hippocastani corticis, matricariae extractum spissum, tormentilla achillea, boerhaavia diffusa, capparis spinosa, 13 years 31/12/2018 31/03/2019 cassia occidentalis, cichorium intybus, eclipta alba, embelia ribes, emblica officinalis, fumaria officinalis, mandur bhasma, phyllanthus amarus, plumbago zeylanica, raphanus sativus, solanum nigrum, tamarix gallica, terminalia arjuna, terminalia chebula, tinospora cordifolia achillea, calendula, clotrimazole, gentamicine 13 years 28/02/2020 28/05/2020 achillea, calendula, crataegus, hypericum, 5 years 31/12/2018 31/03/2019 matricaria, polygonum, rosa achillea, calendula, crataegus, humulus lupulus, 13 years 31/12/2018 31/03/2019 linum, matricaria, mentha piperita, plantago major achillea, calendula, hypericum, mentha, 5 years 31/12/2018 31/03/2019 plantago, sambucus, tussilago achillea, calendula, hypericus, matricaria, 13 years 31/12/2018 31/03/2019 menthae piperitae achillea, calendula, matricaria 13 years 31/12/2018 31/03/2019 achillea, calendula, chelidonium, matricaria, 13 years 31/12/2018 31/03/2019 mentha piperita, tanacetum achillea, calendula, chelidonium, lavandula, 13 years 31/12/2018 31/03/2019 matricaria, mentha piperita, tanacetum achillea, calendula, lavandula, matricaria, 13 years 31/12/2018 31/03/2019 mentha piperita, tanacetum achillea, calendulae, hypericum, matricariae, 5 years 31/12/2018 31/03/2019 menthae piperitae achillea, carophylenum, propolis, sophora 13 years 31/12/2018 31/03/2019 japonica, potentilla achillea, coriandrum, helichrysum arenarium, 13 years 31/12/2018 31/03/2019 mentha piperita achillea, crataegus, humulus lupulus, mentha 13 years 31/12/2018 31/03/2019 piperita, valeriana achillea, lycium cortice, urtica foliis 13 years 31/12/2018 31/03/2019 achyranthes aspera, cyperus scariosus, 13 years 31/12/2018 31/03/2019 didymocarpus pedicellata, dolichos biflorus, equisetum arvense, hajrul yahood bhasma, mimosa pudica, ocimum basilicum, onosma bracteatum, pavonia odorata, rubia cordifolia, saxifraga ligulata, shilajeet purified, tectona grandis seed, tribulus terrestris, vernonia cinerea aciclovir 3 years 09/06/2018 07/09/2018 aciclovir, hydrocortisone 3 years 30/07/2020 28/10/2020 aciclovir, interferon alfa-2b, lidocaine 3 years 09/06/2018 07/09/2018 acid citric, adenine, dextrose monohydrate, 13 years 30/05/2020 28/08/2020 sodium citrate, sodium dihydrogen phosphate acid citric, adenine, glucose monohydrate, 13 years 30/05/2020 28/08/2020 mannitol, sodium citrate, sodium chloride, sodium dihydrogen phosphate acidum acetylsalicylicum, acidum alpha- 13 years 31/12/2018 31/03/2019 liponicum, acidum ascorbicum, acidum sarcolacticum, adenosinum triphosphoricum, anthrachinonum, coenzym, colchicum autumnale, conium maculatum, galium aparine, histaminum, hydrastis canadensis, hydrochinonum, magnesium gluconicum, manganum phosphoricum, nadidum, naphthochinonum, natrium diethyloxalaceticum, natrium riboflavinum phosphoricum, nicotinamidum, p-benzochinonum, podophyllum peltatum, pyridoxinum hydrochloricum, sulfur, thiaminum hydrochloricum, trichinoylum, ubidecarenonum, vaccinium myrtillus acidum a-ketoglutaricum, acidum ascorbicum, 13 years 31/12/2018 31/03/2019 acidum cis-aconiticum, acidum citricum, acidum fumaricum, acidum malicum, acidum succinicum, acidum thiocticum, adenosinum triphosphoricum, barium oxalsuccinicum, beta vulgaris rubra, cerium oxalicum, coenzym A, cysteinum, hepar sulfuris, magnesium oroticum dihydricum, manganum phosphoricum, nadidum, natrium diethyloxalaceticum, natrium pyruvicum, natrium riboflavinum phosphoricum, nicotinamidum, pulsatilla pratensis, pyridoxinum hydrochloricum, sulfur, thiaminum hydrochloricum acidum a-ketoglutaricum, acidum fumaricum, 13 years 31/12/2020 31/03/2021 acidum malicum, acidum oroticum monohydricum, acidum thiocticum, avena sativa, calcium carbonicum Hahnemanni, chelidonium majus, cinchona pubescens, colon suis, cyanocobalaminum, cynara scolymus, duodenum suis, hepar suis, histaminum, lycopodium clavatum, natrium diethyloxalaceticum,