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The convention used to present the active substances and combinations of active substances has changed. From the 29th October 2015 the following principles apply:

- A slash ('/') is used to separate the different active substances contained in a combination, this can be a fixed-dose combination or a combination pack.

- A comma (',') is used to indicate that a single PSUR assessment covering the different substances and/or combinations of active substances will be produced.43453EMA/630645/2012 Rev. 76Procedure Management DepartmentList of Union reference dates and frequency of submission of periodic safety update reports (PSURs)Related Information:Introductory cover note to the List of European Union reference dates and frequency of submission of PSURs including requirements for PSURs submissionhttp://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/10/WC500133157.pdfRequests for amendments of the EU reference dates listhttp://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2012/10/WC500133160.xlsThe PSUR assessment procedure will start according to the Timetables published on EMA website following the Submission Dates indicated in column E and G belowhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000330.jsp&mid=WC0b01ac05803d8b9cSingle Assessment Reports of PSURs are shared among all Marketing Authorisation Holders involved in the concerned procedure.Active substances and combinations of active substancesEuropean Union reference date (EURD)

Not Available* = EURD not provided during the consultation phasesPSUR Submission FrequencyDLPSubmission date

(According to the timelines defined in GVP Module VII, Section A)Next DLP

(For active substances or combination of active substances with a PSUR frequency of less than one year)Next Submission date

(According to the timelines defined in GVP Module VII, Section A - For active substances or combination of active substances with a PSUR frequency of less than one year)Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended?

Yes/NoPublication Date (in accordance with Article 107c(7) of Directive 2001/83/EC as amended)NotesProcedure number of the PSUR single assessment

(DLP)Procedure number of the PSUR single assessment

procedure (Next DLP)PRAC representative of the PSUR single assessment

procedure(Lead) Member State of the PSUR single assessment procedure dolutegravir / rilpivirine432366 months43419434894360043670No43285PRAC Representative updated on 26/09/2018

New CAP authorised on 16/05/2018PSUSA/00010689/201811PSUSA/00010689/201905Adrien InoubliFrance1,3-butanediol / cinchocaine hydrochloride / dexamethasone3058213 years4579245882No41183PSUSA/00000759/202505125i-human serum albumin15/12/198913 years4600646096No41183PSUSA/00000003/202512131i-6-iodo-norcholesterol21/06/199013 years4582945919No41183PSUSA/00000004/202506¹³C-urea356565 years4494145031No43369DLP was updated on 26/09/2018

Reference to NAP removed on 25/09/2017

PRAC Rapporteur name updated on 12/05/2015PSUSA/00000006/202301Jan NeuhauserAustria1-propanol / 2-propanol / lactic acid298365 years4371543805No42335Procedure number was corrected on 18/11/2016

New substance added on 27/11/2015PSUSA/00010414/2019091-propanol / 2-propanol / orthophenylphenol295175 years4376143851No43227Entry name changed and Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?

Yes/No was updated on 07/05/2018

New substance added on 27/11/2015PSUSA/00010406/2019105 fluorouracil (i.v. application)284753 years4418144271Yes43369DLP was updated on 26/09/2018

DLP updated on 06/10/2015

Lead MS was amended on 06/03/2015

Lead MS was added on 22/12/2014PSUSA/00000007/202012Martin HuberGermany5 fluorouracil (topical application)Not Available*1 year43481435714384643916No43369PSUR Frequency and DLP updated on 26/09/2018

Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017

DLP updated on 06/10/2015

Lead MS was amended on 06/03/2015

Lead MS was added on 22/12/2014PSUSA/00010000/201901PSUSA/00010000/202001Martin HuberGermany5 fluorouracil / salicylic acid344793 years4324543335No41183Next DLP was updated on 04/02/2016

Lead MS was added on 06/03/2015PSUSA/00000008/201805Tatiana MagalovaSlovakia5-aminolevulinic acid (glioma)393323 years4426244352No43396DLP was updated on 23/10/2018

PRAC Rapporteur name updated on 30/01/2017

PRAC Rapporteur name was amended on 20/12/2016

PRAC Rapporteur name updated on 07/04/2016

Next DLP updated on 29/10/2015

Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 06/10/2015

PSUSA/00000009/202103Marcia Sofia Sanches de Castro Lopes Silva Portugal5-aminolevulinic acid (keratosis)393323 years4326543355No42404PSUR Frequency amended and DLP updated on 04/02/2016

DLP updated on 04/02/2015PSUSA/00010006/201806Martin HuberGermanyabacavir359753 years4383043920Yes42579PRAC Representative updated on 26/09/2018

Next DLP was amended on 25/09/2017

PRAC Representative was amended on 28/03/2017

Reference to NAP products was updated on 30/01/2017

Next DLP and PRAC Rapporteur name were amended on 28/07/2016PSUSA/00000010/201912Adrien InoubliFranceabacavir / lamivudine379393 years4383043920Yes42579PRAC Representative updated on 26/09/2018

Next DLP was amended on 25/09/2017

PRAC Representative was amended on 28/03/2017

Reference to NAP products was updated on 30/01/2017

Next DLP and PRAC Rapporteur name were amended on 28/07/2016PSUSA/00000011/201912Adrien InoubliFranceabacavir / lamivudine / zidovudine368883 years4383043920Yes42579PRAC Representative updated on 26/09/2018

Next DLP was amended on 25/09/2017

PRAC Representative was amended on 28/03/2017

Next DLP and PRAC Rapporteur name were amended on 28/07/2016

PSUSA procedure published on 01/04/2014PSUSA/00003144/201912Adrien InoubliFranceabatacept387083 years4382143911No41859PRAC Rapporteur name was amended on 21/11/2018

Next DLP was amended on 25/09/2017

Correction of DLP was done on 02/05/2014

PRAC Rapporteur name updated on 05/11/2018PSUSA/00000013/201912Kimmo JaakkolaFinlandabciximab346495 years4524245332No43453Lead MS and PRAC Rapporteur name amended on 19/12/2018

DLP was updated on 31/07/2018

Lead MS and PRAC Rapporteur name was added on 26/04/2017PSUSA/00000014/202311Amelia CupelliItalyabemaciclib430066 months43552436224373643806No43425New CAP authorised on 27/09/2018PSUSA/00010724/201903PSUSA/00010724/201909Marcia Sofia Sanches de Castro Lopes Silva Portugalzinc acetate dihydrate382735 years4449944589No43453PRAC Rapporteur name updated on 19/12/2018

PRAC Rapporteur name was amended on 23/10/2018

Next DLP was amended on 27/06/2017PSUSA/00003145/202110Rhea FitzgeraldIrelandacamprosate319828 years4474344833No42069Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015PSUSA/00000016/202207venetoclax427096 months43255433254343843508No43453PRAC Representative and LMS updated on 19/12/2018

DLP was updated on 04/07/2018

DLP was amended on 31/01/2018

PRAC Representative amended on 28/03/2017

New CAP authorised on 05/12/2016 PSUSA/00010556/201806PSUSA/00010556/201812Eva JirsováCzech Republicacebutolol273795 years4491145001No43369DLP was updated on 26/09/2018

PRAC representative and Lead Member State were added on 23/05/2017

Next DLP and EURD were amended on 03/03/2014PSUSA/00000018/202212Doris StenverDenmarkaceclofenac329513 years4392144011No42493DLP was updated on 19/12/2017

Lead MS and PRAC Rapporteur name was added on 19/10/2016

Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 03/05/2016

Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 04/02/2015PSUSA/00000022/202003Julia PallosHungaryacemetacinNot Available*6 years4322143311No41183PRAC representative added on 17/10/2017PSUSA/00000026/201805Julia PallosHungaryacenocoumarol06/07/19559 years4437844468No41183PSUSA/00000027/202107acetazolamide27/07/195316 years4705247142Yes42822DLP was updated on 28/03/2017PSUSA/00000029/202810acetic acidNot Available*13 years4565845748No41183PSUSA/00000030/202501acetic acid glacial / dexamethasone / neomycinNot Available*13 years4565845748No41183PSUSA/00000976/202501acetyl salicylic acid / atorvastatin / ramipril416903 years4388143971No41918DLP was amended on 15/11/2017

Lead MS was added on 22/09/2016PSUSA/00010280/202002Jan NeuhauserAustriaacetylated wool alcohols / liquid paraffinNot Available*13 years4565845748No41183PSUSA/00009216/202501acetylcholine09/06/196516 years4690546995No41183PSUSA/00000033/202806acetylcysteine14/09/19633 years4335643446No41183Next DLP was amended on 03/06/2016

Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 13/07/2015PSUSA/00000034/201809Adam PrzybylkowskiPolandacetylcysteine / benzalkonium chloride / tuaminoheptane sulfateNot Available*13 years4565845748No41183PSUSA/00000349/202501acetylcysteine / tuaminoheptane01/03/197113 years4571745807No41183PSUSA/00000035/202503acetyldigoxinNot Available*13 years4565845748No41183PSUSA/00000036/202501acetyldigoxin combinationsNot Available*13 years4565845748No41183PSUSA/00000037/202501acetylsalicylic acid156313 years4349743587No41183Next DLP was amended on 19/10/2016

Lead MS was added on 31/07/2015PSUSA/00000039/201902Julia PallosHungaryacetylsalicylic acid / ascorbic acid2650823 years4934449434No41183PSUSA/00000241/203502acetylsalicylic acid / ascorbic acid / bioflavonoidsNot Available*23 years4931049400No41183PSUSA/00000242/203501acetylsalicylic acid / ascorbic acid / caffeine / chlorphenamine maleateNot Available*13 years4565845748No41183PSUSA/00000695/202501acetylsalicylic acid / ascorbic acid / chlorphenamine / colae semenNot Available*13 years4565845748No41183PSUSA/00009001/202501acetylsalicylic acid / ascorbic acid / chlorphenamine maleate / phenylephrine hydrochlorideNot Available*13 years4565845748No41183PSUSA/00000705/202501acetylsalicylic acid / ascorbic acid / codeine phosphate hemihydrateNot Available*23 years4931049400No41183PSUSA/00000243/203501acetylsalicylic acid / ascorbic acid / paracetamol3139423 years4931049400No41183PSUSA/00000252/203501acetylsalicylic acid / bisoprolol404873 years4340943499No43453Lead MS and PRAC Rapporteur name amended on 19/12/2018

Next DLP was updated and PSUR Frequency amended on 28/06/2016

Next DLP was updated and PSUR Frequency amended on 21/12/2015

Lead MS was added on 06/03/2015

For advice on submission for DLPs falling before 05/05/2015 please consult the List of substance under Work sharing scheme and other substance contained in Nationally Authorised Products with DLPs synchronised.PSUSA/00010287/201811Tatiana MagalovaSlovakiaacetylsalicylic acid / caffeineNot Available*18 years4748447574No41183PSUSA/00000041/203001acetylsalicylic acid / caffeine / codeine / paracetamolNot Available*13 years4565845748No41183PSUSA/00002292/202501acetylsalicylic acid / caffeine / codeine phosphateNot Available*18 years4748447574No41183PSUSA/00000042/203001acetylsalicylic acid / caffeine / etenzamideNot Available*18 years4748447574No41183PSUSA/00000043/203001acetylsalicylic acid / caffeine / paracetamol2659613 years4595446044No41183PSUSA/00002291/202510acetylsalicylic acid / calcium carbonateNot Available*18 years4748447574No41183PSUSA/00000044/203001acetylsalicylic acid / chlorphenamine / phenylephrineNot Available*13 years4565845748No41183PSUSA/00000694/202501acetylsalicylic acid / citric acid / sodium hydrogen carbonateNot Available*13 years4565845748No41183PSUSA/00002749/202501acetylsalicylic acid / clopidogrel, clopidogrel359913 years4378643876No41859DLP was updated on 21/07/2017

PRAC Rapporteur name updated on 30/01/2017

PRAC Rapporteur name updated on 04/02/2016

PRAC representative name was amended on 31/07/2015.

Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 08/08/2014

Name of active substance was amended on 30/04/2013PSUSA/00000820/201911Marcia Sofia Sanches de Castro Lopes Silva Portugalacetylsalicylic acid / codeine phosphateNot Available*18 years4748447574No41183PSUSA/00000046/203001acetylsalicylic acid / codeine phosphate / paracetamolNot Available*13 years4565845748No41183PSUSA/00009003/202501acetylsalicylic acid / dipyridamole3406413 years4575245842No41183PSUSA/00001139/202504acetylsalicylic acid / glycineNot Available*18 years4748447574No41183Active substance name was amended on 06/03/2015PSUSA/00000040/203001acetylsalicylic acid / magnesium hydroxideNot Available*13 years4565845748No41183PSUSA/00000047/202501acetylsalicylic acid / methocarbamolNot Available*13 years4565845748No41183PSUSA/00002012/202501acetylsalicylic acid / oxycodone hydrochlorideNot Available*13 years4565845748Yes41183PSUSA/00002255/202501acetylsalicylic acid / paracetamolNot Available*13 years4565845748No41183PSUSA/00002290/202501aciclovir10/06/19813 years4326043350No41183Next DLP amended on 04/03/2016

Lead MS added on 01/04/2015PSUSA/00000048/201806Doris StenverDenmarkaciclovir / hydrocortisone400253 years4404244132No42069DLP was updated on 07/05/2018

PRAC representative and Lead Member State were added on 30/01/2017

Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015PSUSA/00009004/202007Jan NeuhauserAustriaacidum malicum levogirum / calcium chloride dihydrate / glucose monohydrate / glycine / l proline / l-alanine / l-arginine / l-histidine / l-isoleucine / l-leucine / l-lysine hydrochloride / l-methionine / l-phenylalanine / l-threonine / l-tryptophane / l-valine / magnesium chloride hexahydrate / potassium chloride / sodium chloride / sodium glycerophosphate pentahydrate / zinc chlorideNot Available*13 years4565845748No41183PSUSA/00001895/202501acipimox308073 years4322543315No42635Next DLP and European Union reference date were updated on 22/09/2016

Lead MS was added on 13/07/2015PSUSA/00000050/201805Doris StenverDenmarkacitretin321121 year4340343473Yes43285DLP was updated on 04/07/2018

Next DLP was amended on 27/06/2017

Next DLP was amended on 28/06/2016

Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/06/2016

Lead MS added on 16/06/2015PSUSA/00000051/201810Doris StenverDenmarkaclidinium bromide411101 year4330143371No42662DLP was updated on 28/02/2018

Next DLP was amended on 28/02/2017

PSUR Frequency amended and next DLP updated on 19/10/2016

Next DLP was updated on 22/09/2016

DLP and Next DLP was updated on 04/03/2016

DLP and Next DLP was updated on 06/10/2015

Next DLP was amended on 06/03/2015

Next DLP was amended on 06/10/2014

Next DLP was amended on 03/03/2014PSUSA/00009005/201807Julie WilliamsUnited Kingdomvedolizumab417791 year4360443674No43453DLP was updated on 19/12/2018

DLP was updated on 04/07/2018

PSUR Frequency amended and DLP updated on 19/12/2017

Next DLP was amended on 27/06/2017

Next DLP was amended on 20/12/2016

Next DLP was updated on 28/06/2016

DLP and Next DLP were corrected on 04/02/2016.

Next DLP was updated on 21/12/2015.

Next DLP was amended on 013/07/2015

Next DLP was amended on 06/10/2014PSUSA/00010186/201905Adam PrzybylkowskiPolandacrivastine3323813 years4602246112No41183PSUSA/00000054/202512acrivastine / pseudoephedrine31/12/199010 years4492645016No41730The DLP was amended on 01/04/2014PSUSA/00000055/202212valsartan / rosuvastatin426553 years4374943839No43453New entry added on 19/12/18PSUSA/00010735/201910adalimumab (biosimilars)428161 year4346543535No43312DLP was updated on 31/07/2018

New CAP authorised on 22/03/2017PSUSA/00010589/201812Ulla Wändel LimingaSwedenadalimumab (except for biosimilars)378723 years4383043920No42851Next DLP was amended on 25/09/2017

Active substance name was amended on 26/04/2017PSUSA/00000057/201912Ulla Wändel LimingaSwedenadapalene03/07/19928 years4331243402No42069PRAC Rapporteur name updated on 23/10/2018

PRAC Representative and Lead MS were added on 19/12/2017PSUSA/00000058/201807Ronan GrimesIrelandadapalene / benzoyl peroxide393553 years4410444194No43257PRAC Rapporteur name was amended on 23/10/2018

DLP was updated on 06/06/2018

PRAC Rapporteur name and country updated on 01/12/2014PSUSA/00000059/202009Annika FolinSwedenadefovir376863 years4336343453No41183PRAC Representative updated on 26/09/2018

PRAC Representative was amended on 28/03/2017

PRAC Rapporteur name was amended on 28/07/2016

Next DLP was updated on 28/06/2016PSUSA/00000060/201809Adrien InoubliFranceademetionine28/04/199313 years4577545865No41183PSUSA/00000061/202504adenine / benfotiamine / carnitine orotate / fructose / nicotinamide / pantothenic acid / potassium orotate / pyridoxine / riboflavin / xanthineNot Available*13 years4565845748No41183PSUSA/00000573/202501adenosine334645 years4478744877No43453Lead MS and PRAC Rapporteur name amended on 19/12/2018

DLP was updated on 07/05/2018

PRAC representative and Lead Member State were added on 30/01/2017PSUSA/00000062/202208Adam PrzybylkowskiPolandadenosine / cytochrome c / nicotinamide / sodium succinate / sorbitolNot Available*13 years4565845748No41183PSUSA/00000063/202501adenosine 5' triphosphate / disodium saltNot Available*13 years4565845748No41183PSUSA/00000064/202501

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