Periodic safety update report single assessments

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The European Medicines Agency (EMA) publishes the outcomes of single assessments of periodic safety update reports (PSURs) for active substances or combinations of active substances contained in medicines authorised in the European Union (EU).

A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

A single assessment of related PSURs is carried out for medicines that contain the same active substance or combination of active substances, as included in the list of EU reference dates (EURD list). EMA’s scientific committees (PRAC and CHMP) and the CMDh together with the lead Member State assess the information in the related PSURs to determine whether the balance of benefits and risks has changed and whether any updates should be made to the marketing authorisation. More information is available in Periodic safety update reports: questions and answers.

The outcomes of PSUR assessments for active substances found only in centrally authorised medicinal products are published as part of each medicine's European public assessment report (EPAR). The outcome for nationally authorised medicinal products included in 'mixed' procedures where centrally authorised products were also involved can be found on the Community register maintained by the European Commission.

Active substances contained in nationally authorised medicines

Use the search below to find the lists of nationally authorised medicines involved in PSUR single assessments for active substances contained only in nationally authorised medicinal products, together with the outcomes of assessments that lead to a variation of marketing authorisations.

When a PSUR single assessment procedure leads to a variation of marketing authorisations, marketing-authorisation holders for nationally authorised products containing the active substance(s) concerned should submit a variation to align their marketing authorisation with the single assessment outcome, even if their product was not in the direct scope of the procedure (such as a generic medicine or a medicine authorised on the basis of well established use). This is in line with Article 23 of Directive 2001/83/EC and Article 16 of regulation (EC) No 726/2004.

Documents presenting 'CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation' contain all language versions within a single PDF file if they were published before 17 October 2016. 

Document status

Regulatory outcome affecting the marketing authorisation:

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PSUSA Search results
Document title Language Active Substance Procedure Number Regulatory Outcome Publication date
Abciximab: List of nationally authorised medicinal products - PSUSA/00000014/201711 (English only) abciximab PSUSA/00000014/201711 Maintenance 2018-07-19
Acarbose: List of nationally authorised medicinal products - PSUSA/00000017/201503 (English only) acarbose PSUSA/00000017/201503 Maintenance 2016-02-09
Aceclofenac : List of nationally authorised medicinal products - PSUSA/00000022/201703 (English only) aceclofenac PSUSA/00000022/201703 Maintenance 2017-12-01
Acetyl salicylic acid / atorvastatin / ramipril: List of nationally authorised medicinal products - PSUSA/00010280/201702 (English only) acetyl salicylic acid/atorvastatin/ramipril PSUSA/00010280/201702 Maintenance 2017-10-27
Acetylcysteine: List of nationally authorised medicinal products - PSUSA/00000034/201509 (English only) acetylcysteine PSUSA/00000034/201509 Maintenance 2016-05-20
Acetylsalicylic acid / bisoprolol: List of nationally authorised medicinal products - PSUSA/00010287/201505 (English only) bisoprolol/acetylsalicylic acid PSUSA/00010287/201505 Maintenance 2015-12-07
Acetylsalicylic acid / bisoprolol: List of nationally authorised medicinal products - PSUSA/00010287/201511 (English only) bisoprolol/acetylsalicylic acid PSUSA/00010287/201511 Maintenance 2016-06-27
Acetylsalicylic acid: List of nationally authorised medicinal products - PSUSA/00000039/201602 (English only) acetylsalicylic acid PSUSA/00000039/201602 Maintenance 2016-10-19
Aciclovir / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00003065/201708 (English only) aciclovir / hydrocortisone PSUSA/00003065/201708 Maintenance 2018-04-19
Aciclovir: List of nationally authorised medicinal products - PSUSA 00000048/201506 (English only) aciclovir PSUSA 00000048/201506 Maintenance 2016-04-06
Acipimox: List of nationally authorised medicinal products - PSUSA/00000050/201512 (English only) acipimox PSUSA/00000050/201512 Maintenance 2016-09-08
Acitretin :List of nationally authorised medicinal products - PSUSA/00000051/201610 (English only) acitretin PSUSA/00000051/201610 Maintenance 2017-06-13
Acitretin: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation- PSUSA/00000051/201510 (English only) acitretin PSUSA/00000051/201510 Variation 2016-08-10
Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201510 (English only) acitretin PSUSA/00000051/201510 Variation 2016-08-10
Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201710 (English only) acitretin PSUSA/00000051/201710 Maintenance 2018-06-15
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 BG = bălgarski adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 ES = español adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 DA = dansk adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 DE = Deutsch adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 EL = elliniká adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 EN = English adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 FR = français adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 IT = italiano adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 LV = latviešu valoda adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 LT = lietuvių kalba adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 HU = magyar adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 MT = Malti adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 NL = Nederlands adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 PL = polski adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 PT = português adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 RO = română adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 SK = slovenčina adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 SL = slovenščina adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 FI = suomi adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 HR = Hrvatski adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 IS = Islenska adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 NO = Norsk adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adapalene / benzoyl peroxide: List of nationally authorised medicinal products - PSUSA/00000059/201409 (English only) benzoyl peroxide/adapalene PSUSA/00000059/201409 Maintenance 2015-07-06
Adapalene / benzoyl peroxide: List of nationally authorised medicinal products - PSUSA/00000059/201709 (English only) adapalene/benzoyl peroxide PSUSA/00000059/201709 Variation 2018-07-12
Adenosine: List of nationally authorised medicinal products - PSUSA/00000062/201708 (English only) adenosine PSUSA/00000062/201708 Maintenance 2018-04-13
Ajmaline: List of nationally authorised medicinal products - PSUSA/00000072/201608 (English only) ajmaline PSUSA/00000072/201608 Maintenance 2017-04-18
Alanine / arginine / aspartic acid / cysteine / glucose anhydrous / glutamic acid / glycine / histidine / isoleucine / leucine / lysine / methionine / olive oil refined / ornithine / phenylalanine / proline / serine / sodium chloride / sodium glycerophosphate hydrated / soya bean oil refined / taurine / threonine...: List of nationally authorised medicinal products - PSUSA/00010190/201506 (English only) glucose anhydrous/cysteine/aspartic acid/arginine/alanine/magnesium acetate tetrahydrate/calcium chloride dihydrate/potassium acetate/valine/tyrosine/tryptophan/threonine/taurine/soya bean oil refined/sodium glycerophosphate hydrated/sodium chloride/serine/proline/phenylalanine/ornithine/olive oil refined/methionine/lysine/leucine/isoleucine/histidine/glycine/glutamic acid PSUSA/00010190/201506 Maintenance 2016-02-22
Alanine / arginine / aspartic acid / cysteine / glucose anhydrous / glutamic acid / glycine / histidine / isoleucine / leucine / lysine / methionine / olive oil refined / ornithine / phenylalanine / proline / serine / sodium chloride / sodium glycerophosphate hydrated / soya bean oil refined / taurine / threonine...: List of nationally authorised medicinal products - PSUSA/00010190/201512 (English only) magnesium acetate tetrahydrate/calcium chloride dihydrate/potassium acetate/valine/tyrosine/tryptophan/threonine/taurine/soya bean oil refined/sodium glycerophosphate hydrated/sodium chloride/serine/proline/phenylalanine/ornithine/olive oil refined/methionine/lysine/leucine/isoleucine/histidine/glycine/glutamic acid/glucose anhydrous/cysteine/aspartic acid/arginine/alanine PSUSA/00010190/201512 Maintenance 2016-09-13
Albendazole: List of nationally authorised medicinal products - PSUSA/00000073/201507 (English only) albendazole PSUSA/00000073/201507 Maintenance 2016-04-04
Alendronate / alfacalcidol: List of nationally authorised medicinal products - PSUSA/00010308/201512 (English only) alfacalcidol/alendronate PSUSA/00010308/201512 Maintenance 2016-07-11
Alendronate: List of nationally authorised medicinal products - PSUSA/00000078/201601 (English only) alendronate PSUSA/00000078/201601 Maintenance 2016-09-13