Outcomes of periodic safety update report single assessments

  • Email
  • Help

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 medicinal products

The table below lists the outcomes of PSUR single assessments for active substances contained only in nationally authorised medicinal products, by alphabetical order of active substance. 

When a PSUR single assessment procedure leads to a variation of marketing authorisations, marketing-authorisation holders for 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. 

Active
substance
CMDh position datePRAC recommen-dation dateProcedure numberRegulatory outcomeDocuments
5 fluorouracil (i.v. application)N/A10/09/2015PSUSA/00000007/
201412
MaintenanceList of nationally authorised medicinal products
5 fluorouracil (topical application)24/09/201510/09/2015PSUSA/00010000/
201412
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

5 fluorouracil, salicylic acidN/A14/01/2016PSUSA/00000008/
201505
MaintenanceList of nationally authorised medicinal products
acarboseN/A03/12/2015PSUSA/00000017/
201503
MaintenanceList of nationally authorised medicinal products
acetylcysteineN/A13/05/2016PSUSA/00000034/
201509
MaintenanceList of nationally authorised medicinal products
acetylsalicylic acid / bisoprololN/A03/12/2015PSUSA/00010287/
201505
MaintenanceList of nationally authorised medicinal products
acetylsalicylic acid / bisoprololN/A13/05/2016PSUSA/00010287/
201511
MaintenanceList of nationally authorised medicinal products
aciclovirN/A11/02/2016PSUSA/00000048/
201506
MaintenanceList of nationally authorised medicinal products
acitretin22/06/201609/06/2016PSUSA/00000051/
201510
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

acipimoxN/A

02/09/2016

PSUSA/00000050/
201512
MaintenanceList of nationally authorised medicinal products
adapalene, benzoyl peroxide

N/A

 

07/05/2015PSUSA/00000059/
201409
MaintenanceList of nationally authorised medicinal products
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 / tryptophan / tyrosine / valine / potassium acetate / calcium chloride dihydrate / magnesium acetate tetrahydrateN/A22/02/2016PSUSA/000010190/
201506
MaintenanceList of nationally authorised medicinal products
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 / tryptophan / tyrosine / valine / potassium acetate / calcium chloride dihydrate / magnesium acetate tetrahydrateN/A02/09/2016PSUSA/00010190/
201512
MaintenanceList of nationally authorised medicinal products
albendazoleN/A17/03/2016PSUSA/00000073/
201507
MaintenanceList of nationally authorised medicinal products
alendronateN/A02/09/2016PSUSA/00000078/
201601
MaintenanceList of nationally authorised medicinal products
alendronate / alfacalcidolN/A07/07/2016PSUSA/00010308/
201512
MaintenanceList of nationally authorised medicinal products
alfentanilN/A13/05/2016PSUSA/00000082/
201509
MaintenanceList of nationally authorised medicinal products
alizapride 

02/09/2016

PSUSA/00000091/
201601
Maintenance List of nationally authorised medicinal products
allopurinolN/A02/09/2016PSUSA/00000095/
201512
MaintenanceList of nationally authorised medicinal products
almagateN/A14/04/2016PSUSA/0000097/
201505
MaintenanceList of nationally authorised medicinal products
alpha-1-antitrypsinN/A10/09/2015PSUSA/00000108/
201412
Maintenance

List of nationally authorised medicinal products

alprostadil (patency of the ductus arteriosus)N/A17/03/2016PSUSA/00010021/
201507
MaintenanceList of nationally authorised medicinal products
altizide, spironolactone23/09/201510/09/2015PSUSA/00002781/
201501
Variation

List of nationally authorised medicinal products
 

CMDh scientific conclusions, amendments to product information and implementation timetable

amiodarone22/07/201509/07/2015PSUSA/00000166/
201412
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

amisulprideN/A10/09/2015PSUSA/00000167/
201501
Maintenance

List of nationally authorised medicinal products

amitriptyline21/10/201508/10/2015PSUSA/00000168/
201501
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

amitriptyline, perphenazine21/10/201508/10/2015PSUSA/00000170/
201501
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

amlodipine besilate / ramipril16/12/201503/12/2015PSUSA/00000181/
201503
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

ampicillin-sulbactam21/10/201508/10/2015PSUSA/00000197/
201502
Variation

List of nationally authorised medicinal products


CMDh scientific conclusions, amendments to product information and implementation timetable

androstanoloneN/A10/09/2015PSUSA/00000212/
201412
Maintenance

List of nationally authorised medicinal products

apomorphine27/01/201614/01/2016PSUSA/00000227/
201505
Variation

List of nationally authorised medicinal products


CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation

apomorphine20/07/201607/07/2016PSUSA/00000227/
201511
Variation

List of nationally authorised medicinal products


 

CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation

argatroban22/10/201508/10/2015PSUSA/00009057/
201501
VariationList of nationally authorised medicinal products

CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation
artemether / lumefantrin (dispersible tablet)N/A03/12/2015PSUSA/0009060/
201504
MaintenanceList of nationally authorised medicinal products
artemether / lumefantrin (dispersible tablet)N/A09/06/2016PSUSA/00009060/
201510
MaintenanceList of nationally authorised medicinal products
asparaginase27/04/201614/04/2016PSUSA/00003161/
201508
Variation

List of nationally authorised medicinal products


CMDh scientific conclusions and grounds for the variation, amendments to product information and implementation timetable

atenolol / chlortalidone20/05/201507/05/2015PSUSA/00000260/
201409
Variation

List of nationally authorised medicinal products


CMDh scientific conclusions, amendments to product information and implementation timetable

atomoxetineN/A07/07/2016PSUSA/0000262/
201511
MaintenanceList of nationally authorised medicinal products
atomoxetineN/A09/07/2015PSUSA/00000262/
201411
MaintenanceList of nationally authorised medicinal products
atovaquoneN/A10/09/2015PSUSA/00000265/
201411
MaintenanceList of nationally authorised medicinal products
azelastine / fluticasoneN/A13/05/2016PSUSA/00010067/
201510
MaintenanceList of nationally authorised medicinal products
azelastineN/A10/09/2015PSUSA/00000277/
201412
MaintenanceList of nationally authorised medicinal products
bemetizide / triamterene24/02/201611/02/2016PSUSA/00009076/
201506
Variation

List of nationally authorised medicinal products


CMDh scientific conclusions, amendments to product information and implementation timetable

benazepril20/07/201607/07/2016PSUSA/00000313/
201511
Variation

List of nationally authorised medicinal products


CMDh scientific conclusions, amendments to product information and implementation timetable

benzydamine20/07/201607/04/2016PSUSA/00000375/
201510
Variation

List of nationally authorised medicinal products


CMDh scientific conclusions, amendments to product information and implementation timetable

beractantN/A13/05/2016PSUSA/00000384/
201510
MaintenanceList of nationally authorised medicinal products
betahistineN/A10/09/2015PSUSA/0000389/
201412
MaintenanceList of nationally authorised medicinal products
betamethasone / tetryzolineN/A11/06/2015PSUSA/00010072/
201409
MaintenanceList of nationally authorised medicinal products
bismuth subcitrate potassium / metronidazole / tetracycline27/01/201614/01/2016PSUSA/00010199/
201505
VariationList of nationally authorised medicinal products

CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation
bisoprololN/A 13/05/2016PSUSA/00000419/
201509
MaintenanceList of nationally authorised medicinal products
bisoprolol / hydrochlorothiazide 02/09/2016PSUSA/00000420/
201511
MaintenanceList of nationally authorised medicinal products
bromocriptineN/A09/06/2016

PSUSA/00000438/
201510

MaintenanceList of nationally authorised medicinal products
cabergolineN/A05/11/2015PSUSA/00000477/
201503
MaintenanceList of nationally authorised medicinal products
caffeine/ergotamineN/A02/09/2016PSUSA/00000485/
201511
MaintenanceList of nationally authorised medicinal products
calcitonin salmon, synthetic analogue of eel calcitonin 11/02/2016PSUSA/00000494/
201506
MaintenanceList of nationally authorised medicinal products
calcitriolN/A10/09/2015PSUSA/00000495/
201501
MaintenanceList of nationally authorised medicinal products
calcium carbonate, famotidine, magnesium hydroxide24/06/201511/06/2015PSUSA/00001351/
201409
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

calcium chloride, glutamic acid, glutathione, histidine, lactobionic acid, magnesium chloride, mannitol, potassium chloride, sodium hydroxideN/A06/11/2015PSUSA/00009162/
201503
MaintenanceList of nationally authorised medicinal products
captoprilN/A03/12/2015PSUSA/00000535/
201504
MaintenanceList of nationally authorised medicinal products
carboprostN/A02/09/2016PSUSA/00000560/
201601
MaintenanceList of nationally authorised medicinal products
carmustine (implant)N/A13/05/2016PSUSA/00010348/
201509
MaintenanceList of nationally authorised medicinal products
carmustine (powder and solvent for solution for infusion)17/12/201503/12/2015PSUSA/00010349/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

cefepimeN/A11/02/2016PSUSA/00000593/
201506
MaintenanceList of nationally authorised medicinal products
cefotaximeN/A02/09/2016PSUSA/00000599/
201512
MaintenanceList of nationally authorised medicinal products
ceftazidimeN/A09/06/2016PSUSA/00000608/
201510
MaintenanceList of nationally authorised medicinal products
cefuroxime sodium (for intracameral use)N/A14/01/2016PSUSA/00010206/
201505
MaintenanceList of nationally authorised medicinal products
cefuroxime sodium (for intracameral use)N/A11/06/2015PSUSA/00010206/
201411
MaintenanceList of nationally authorised medicinal products
ceftriaxoneN/A14/01/2016PSUSA/00000613/
201505
MaintenanceList of nationally authorised medicinal products
celecoxibN/A10/09/2015PSUSA/00000616/
201412
MaintenanceList of nationally authorised medicinal products
chloroquine 31/03/2016 17/03/2016 PSUSA/00000685/
201508 
Variation 

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

chlorquinadol (vaginal tablet) / promestrieneN/A13/05/2016PSUSA/00009272/
201509
MaintenanceList of nationally authorised medicinal products
ciclesonideN/A14/04/2016PSUSA/00000742/
201508
MaintenanceList of nationally authorised medicinal products
ciclosporin (systemic use)N/A02/09/2016PSUSA/00001804/
201512
MaintenanceList of nationally authorised medicinal products
cilazapril, cilazapril / hydrochlorothiazideN/A08/10/2015PSUSA/00000749/
201502
MaintenanceList of nationally authorised medicinal products
cilostazolN/A 14/04/2016 PSUSA/00010209/
201508
MaintenanceList of nationally authorised medicinal products
cilostazol21/10/201508/10/2015PSUSA/00010209/
201502
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

ciprofloxacin hydrochloride, dexamethasone acetate (ear drops, suspension)

 N/A03/12/2015PSUSA/00010012/
201504
MaintenanceList of nationally authorised medicinal products
ciprofloxacin hydrochloride, hydrocortisoneN/A09/07/2015PSUSA/00000774/
201411
MaintenanceList of nationally authorised medicinal products
cisatracuriumN/A17/032016PSUSA/00000777/
201507
MaintenanceList of nationally authorised medicinal products
clevidipineN/A1/01/2016PSUSA/00010288/
201505
MaintenanceList of nationally authorised medicinal products
clevidipineN/A07/07/2016PSUSA/00010288/
201511
MaintenanceList of nationally authorised medicinal products
clindamycinN/A09/06/2016PSUSA/00000795/
201510
MaintenanceList of nationally authorised medicinal products
clobetasolN/A08/10/2015PSUSA/00000799/
201502
MaintenanceList of nationally authorised medicinal products
clonazepamN/A11/02/2016PSUSA/00000812/
201506
MaintenanceList of nationally authorised medicinal products
clotiazepamN/A14/01/2016PSUSA/00000827/
201505
MaintenanceList of nationally authorised medicinal products
corticorelin24/06/201511/06/2015PSUSA/00000876/
201410
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

cyproheptadine24/09/201510/09/2015PSUSA/00000902/
201412
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

dalteparin sodiumN/A14/04/2016PSUSA/00000922/
201508
MaintenanceList of nationally authorised medicinal products
dapoxetineN/A09/07/2015PSUSA/00000928/
201412
MaintenanceList of nationally authorised medicinal products
daunorubicinN/A11/02/2016PSUSA/00000936/
201506
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

delapril23/09/201510/09/2015PSUSA/00000946/
201501
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

desfluranN/A11/06/2015PSUSA/0000958/
201409
MaintenanceList of nationally authorised medicinal products
desmopressinN/A10/09/2015PSUSA/00000964/
201412
MaintenanceList of nationally authorised medicinal products
desogestrel / ethinylestradiolN/A13/05/2016PSUSA/00000967/
201509
MaintenanceList of nationally authorised medicinal products
dexchlorpheniramineN/A11/02/2015PSUSA/00000989/
201506
MaintenanceList of nationally authorised medicinal products
dextromethorphan20/07/201607/07/2016PSUSA/00001009/
201511
Variation

List of nationally authorised medicinal products
 

CMDh scientific conclusions, amendments to product information and implementation timetable

diacereinN/A07/07/2016PSUSA/00001026/
201512
MaintenanceList of nationally authorised medicinal products
diclofenac (topical formulation)N/A13/05/2016PSUSA/00010342/
201509
MaintenanceList of nationally authorised medicinal products

diclofenac (systemic formulations)

25/05/201613/05/2016PSUSA/00001048/
201509
Variation

List of nationally authorised medicinal products
 

CMDh scientific conclusions, amendments to product information and implementation timetable

didanosineN/A09/06/2016PSUSA/00001054/
201510
MaintenanceList of nationally authorised medicinal products
dihydroergocristineN/A03/12/2015PSUSA/00001071/
201504
MaintenanceList of nationally authorised medicinal products
dihydroergocryptineN/A11/02/2016PSUSA/00001074/
201507
MaintenanceList of nationally authorised medicinal products
dihydroergotamineN/A03/12/2015PSUSA/00001075/
201504
MaintenanceList of nationally authorised medicinal products
dihydroergotoxine03/12/201503/12/2015PSUSA/00001079/
201504
MaintenanceList of nationally authorised medicinal products
diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated), haemophilus type b conjugate vaccineN/A09/07/2015PSUSA/00001124/
201411
MaintenanceList of nationally authorised medicinal products
diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) reduce antigens contentN/A17/03/2016PSUSA/00001126/
201507
MaintenanceList of nationally authorised medicinal products
diphtheria tetanus vaccines (adsorbed)N/A14/01/2016PSUSA/00001128/
201505
MaintenanceList of nationally authorised medicinal products
dobutamineN/A06/11/2015PSUSA/00001151/
201503
MaintenanceList of nationally authorised medicinal products
domperidoneN/A10/09/2015PSUSA/00001158/
201501
MaintenanceList of nationally authorised medicinal products
drospirenone / estradiolN/A09/07/2015PSUSA/00001184/
201412
MaintenanceList of nationally authorised medicinal products
enalapril, nitrendipineN/A10/09/2015PSUSA/00001213/
201501
MaintenanceList of nationally authorised medicinal products
erythromycin / isotretinoinN/A14/04/2016PSUSA/00001796/
201508
MaintenanceList of nationally authorised medicinal products
escherichia coli lysate 17/03/2016PSUSA/00001263/
201507
MaintenanceList of nationally authorised medicinal products
ethinylestradiol / etongestrelN/A11/02/2016PSUSA/00001307/
201507
MaintenanceList of nationally authorised medicinal products
ethinylestradiol / gestodene (transdermal application)N/A17/03/2016PSUSA/00010145/
201508
MaintenanceList of nationally authorised medicinal products
ethinylestradiol, gestodene (transdermal application)N/A10/09/2015PSUSA/00010145/
201502
MaintenanceList of nationally authorised medicinal products
etifoxineN/A11/06/2015PSUSA/00001321/
201410
MaintenanceList of nationally authorised medicinal products
etonogestrelN/A14/04/2016PSUSA/00001331/
201509
MaintenanceList of nationally authorised medicinal products
everolimus (indicated for rejection of transplanted organs)N/A17/03/2016PSUSA/00010269/
201507
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetableexemestane

exemestaneN/A02/09/2016PSUSA/00001345/
201512
MaintenanceList of nationally authorised medicinal products
famotidine24/06/201511/06/2015PSUSA/00001350/
201409
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

fenoterol (obstetric indications)N/A13/05/2016PSUSA/00010001/
201509
MaintenanceList of nationally authorised medicinal products
fentanyl (transdermal patches, solution for injection)N/A14/01/2016PSUSA/00001370/
201504
MaintenanceList of nationally authorised medicinal products
finasterideN/A14/04/2016PSUSA/00001392/
201508
MaintenanceList of nationally authorised medicinal products
(18f) fludeoxyglucoseN/A09/07/2015PSUSA/00001437/
201411
MaintenanceList of nationally authorised medicinal products

flumazenil

N/A02/09/2016PSUSA/00001413/
201512
MaintenanceList of nationally authorised medicinal products
flunarizineN/A14/01/2016PSUSA/00001416/
201505
MaintenanceList of nationally authorised medicinal products
flunitrazepamN/A02/09/2016PSUSA/00001418/
201601
MaintenanceList of nationally authorised medicinal products
fluocinolone acetonide (intravitreal implant in applicator)N/A14/04/2016PSUSA/00010224/
201508
MaintenanceList of nationally authorised medicinal products
fluocinolone acetonide (intravitreal implant in applicator)N/A08/10/2015PSUSA/00010224/
201502
MaintenanceList of nationally authorised medicinal products
flupirtineN/A10/09/2015PSUSA/00010225/
201501
MaintenanceList of nationally authorised medicinal products
fluticasone propionate / formoterol fumarate dihydrateN/A17/03/2016PSUSA/00010339/
201507
MaintenanceList of nationally authorised medicinal products
fosinoprilN/A17/03/2016PSUSA/00001474/
201507
MaintenanceList of nationally authorised medicinal products

fosinopril hydrochlorothiazide

 

N/A 17/03/2016   PSUSA/00001475/
201507 
Maintenance List of nationally authorised medicinal products
furosemide / spironolactone 20/07/2016 07/07/2016PSUSA/00001493/
201512
 Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

furosemide23/09/201510/09/2015PSUSA/00001491/
201501
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

gadobenic acid27/01/201614/01/2016PSUSA/00001500/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

gadobutrol27/01/201614/01/2016PSUSA/00001502/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

gadodiamide27/01/201614/01/2016PSUSA/00001503/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

gadopentetic acid27/01/201614/01/2016PSUSA/00001504/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

gadoteric acid (IV and intravascular formulations)

27/01/201614/01/2016PSUSA/00001506/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

gadoteridol27/01/201614/01/2016PSUSA/1507/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

gadoxetic acid disodium27/01/201614/01/2016PSUSA/00001509/
201504
VariationList of nationally authorised medicinal products

CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation
gaxiloseN/A02/09/2016PSUSA/00010283/
201601
MaintenanceList of nationally authorised medicinal products
gasiloxeN/A10/09/2015PSUSA/00010283/
201501
MaintenanceList of nationally authorised medicinal products
gaxiloseN/A17/03/2016PSUSA/00010283/
201507
MaintenanceList of nationally authorised medicinal products
germanium (68Ge) chloride / gallium (68Ga) chlorideN/A15/04/2016PSUSA/00010364/
201509
MaintenanceList of nationally authorised medicinal products
glatiramerN/A10/09/2015PSUSA/00001529/
201411
MaintenanceList of nationally authorised medicinal products
glibenclamide / metformin hydrochloride24/02/201611/02/2016PSUSA/00002002/
201506
VariationList of nationally authorised medicinal products

CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation
glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease)25/05/201613/05/2016PSUSA/00001556/
201509
VariationList of nationally authorised medicinal products

CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation
glycopyrronium / neostigmine25/05/201613/05/2016PSUSA/00001557/
201509
VariationList of nationally authorised medicinal products

CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation
hexaminolevulinate hydrochloride

N/A

07/05/2015PSUSA/00001606/
201409
MaintenanceList of nationally authorised medicinal products
hexoprenaline sulfateN/A14/04/2016PSUSA/00003170/
201508
MaintenanceList of nationally authorised medicinal products
human anti-d immunoglobulinN/A03/12/2015PSUSA/00001614/
201503
MaintenanceList of nationally authorised medicinal products
human coagulation factor VIII (antihemophilic factor A)N/A09/07/2015PSUSA/00001620/
201411
MaintenanceList of nationally authorised medicinal products
human coagulation factor VIII / human von Willebrand factorN/A09/06/2016PSUSA/00001621/
201510
MaintenanceList of nationally authorised medicinal products
human fibrinogenN/A 11/02/2016PSUSA/00001624/
201506
MaintenanceList of nationally authorised medicinal products
human von willebrand factorN/A11/06/2015PSUSA/00001642/
201409
MaintenanceList of nationally authorised medicinal products
hydrochlorothiazide, ramiprilN/A10/09/2015PSUSA/00001660/
201501
MaintenanceList of nationally authorised medicinal products
hydrochlorothiazide, spironolactone23/09/201510/09/2015PSUSA/00001662/
201501
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

hydroxyethyl starchN/A09/07/2015PSUSA/00001694/
201501
MaintenanceList of nationally authorised medicinal products
hydroxyzine chloride, hydroxyzine pamoate and all fixed combination /  hydroxyzineN/A11/06/2015PSUSA/00001696/
201411
MaintenanceList of nationally authorised medicinal products
ibuprofen / pseudoephedrineN/A11/02/2016PSUSA/00001711/
201507
MaintenanceList of nationally authorised medicinal products
idebenoneN/A11/06/2015PSUSA/00001721/
201409
MaintenanceList of nationally authorised medicinal products
iloprost (iv solution)N/A08/10/2015PSUSA/00009190/
201501
MaintenanceList of nationally authorised medicinal products
indapamideN/A07/07/2016PSUSA/00001731/
201511
MaintenanceList of nationally authorised medicinal products
influenza vaccine (split virion, inactivated) (non centrally authorised products)N/A14/04/2016PSUSA/00010298/
201508
MaintenanceList of nationally authorised medicinal products
influenza vaccine (split virion, inactivated, prepared in cell cultures)N/A14/04/2016PSUSA/00010299/
201508
MaintenanceList of nationally authorised medicinal products
influenza vaccine (split virion, inactivated, prepared in cell cultures)N/A03/12/2015PSUSA/00010299/
201504
MaintenanceList of nationally authorised medicinal products
influenza vaccine (split virion, inactivated) (non centrally authorised products)N/A03/12/2015PSUSA/00010298/
201504
MaintenanceList of nationally authorised medicinal products
influenza vaccine (surface antigen, inactivated)N/A14/04/2016PSUSA/00001744/
201508
MaintenanceList of nationally authorised medicinal products
influenza vaccine (surface antigen, inactivated, adjuvanted)N/A14/04/2016PSUSA/00010300/
201508
MaintenanceList of nationally authorised medicinal products
influenza vaccine (surface antigen, inactivated, virosome)N/A14/04/2016PSUSA/00001746/
201508
MaintenanceList of nationally authorised medicinal products
influenza vaccine (surface antigen, inactivated, virosome)N/A03/12/2015PSUSA/00001746/
201504
MaintenanceList of nationally authorised medicinal products
influenza vaccine (surface antigen, inactivated, adjuvanted)N/A03/12/2015PSUSA/00010300/
201504
MaintenanceList of nationally authorised medicinal products
influenza vaccine (surface antigen, inactivated)N/A03/12/2015PSUSA/0001744/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

insulin porcineN/A11/06/2015PSUSA/00001756/
201410
MaintenanceList of nationally authorised medicinal products
iodine (131i) iobenguane19/05/201611/05/2016PSUSA/00001764/
201505
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

isoniazid24/06/201511/06/2015PSUSA/00001789/
201411
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

isotretinoinN/A14/01/2016PSUSA/00001795/
201505
MaintenanceList of nationally authorised medicinal products
ivermectin (topical use)22/06/201609/06/2016PSUSA/00010376/
201510
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

ketamineN/A02/09/2016PSUSA/00001804/
201512
MaintenanceList of nationally authorised medicinal products
ketoprofen (topical use only)N/A13/05/2016PSUSA/00009205/
201509
MaintenanceList of nationally authorised medicinal products
ketotifen (oral formulations)N/A11/06/2015PSUSA/00001813/
201410
MaintenanceList of nationally authorised medicinal products
lactitolN/A 13/05/2016PSUSA/00001819/
201509
MaintenanceList of nationally authorised medicinal product
latanoprost (products with paediatric indication)N/A13/05/2016PSUSA/00001834/
201510
MaintenanceList of nationally authorised medicinal product
latanoprost (products with paediatric indication)N/A06/11/2015PSUSA/00001834/
201504
MaintenanceList of nationally authorised medicinal products
letrozoleN/A11/06/2015PSUSA/00001437/
201410
MaintenanceList of nationally authorised medicinal products
letrozoleN/A09/06/2016PSUSA/00001842/
201510
MaintenanceList of nationally authorised medicinal products
levofloxacin 13/05/2016PSUSA/00001854/
201510
MaintenanceList of nationally authorised medicinal products
levonorgestrelN/A10/09/2015PSUSA/00001856/
201412
MaintenanceList of nationally authorised medicinal products
lidocaine hydrochloride / phenylephrine hydrochloride / tropicamideN/A02/09/2016PSUSA/00010390/
201601
MaintenanceList of nationally authorised medicinal products
lisdexamfetamineN/A08/10/2015PSUSA/00010289/
201502
MaintenanceList of nationally authorised medicinal products
lisdexamfetamineN/A17/03/2016PSUSA/00010289/
201508
MaintenanceList of nationally authorised medicinal products
lisinoprilN/A13/05/2016PSUSA/00001894/
201509
MaintenanceList of nationally authorised medicinal products
lisurideN/A09/07/2015PSUSA/00001896/
201411
MaintenanceList of nationally authorised medicinal products
lormetazepam23/10/201510/09/2015PSUSA/00001910/
201412
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

lubiprostoneN/A17/03/2016PSUSA/00010290/
201507
MaintenanceList of nationally authorised medicinal products
lubiprostoneN/A02/09/2016PSUSA/00010290/
201601
MaintenanceList of nationally authorised medicinal products
magnesium sulfateN/A11/02/2016PSUSA/00009225/
201506
MaintenanceList of nationally authorised medicinal products
magnesium sulphate, sodium sulphate, potassium sulphateN/A10/09/2015PSUSA/00010239/
201502
MaintenanceList of nationally authorised medicinal products
magnesium sulphate / sodium sulphate / potassium sulphateN/A17/03/2016PSUSA/00010239/
201508
MaintenanceList of nationally authorised medicinal products
magnesium sulphate / sodium sulphate / potassium sulphateN/A02/09/2016PSUSA/00010239/
201602
MaintenanceList of nationally authorised medicinal products
manidipineN/A11/02/2016PSUSA/00001932/
201506
MaintenanceList of nationally authorised medicinal products
meningococcal group c polysaccharide conjugate vaccineN/A09/06/2016PSUSA/00001971/
201510
MaintenanceList of nationally authorised medicinal products
meropeneml27/04/201614/04/2016PSUSA/00001989/
201508
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions and grounds for variation, amendments to the Product Information and the implementation timetable

mesalazineN/A08/10/2015PSUSA/00001990/
201502
MaintenanceList of nationally authorised medicinal products
metamizoleN/A03/12/2015PSUSA/00001997/
201504
MaintenanceList of nationally authorised medicinal products
metforminN/A03/12/2015PSUSA/00002001/
201504
MaintenanceList of nationally authorised medicinal products
methylphenidateN/A09/06/2016PSUSA/00002024/
201510
MaintenanceList of nationally authorised medicinal products
methylprednisolone23/09/201510/09/2015PSUSA/00002026/
201411
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to the product information and timetable for the implementation

methysergideN/A08/10/2015PSUSA/00002030/
201502
MaintenanceList of nationally authorised medicinal products
metoclopramide22/06/201609/06/2016PSUSA/00002036/
201510
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to the product information and timetable for the implementation

miconazole / hydrocortisone, miconazole nitrate / miconazole nitrate, zinc oxide24/06/201511/06/2015PSUSA/00002052/
201410
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

milnacipran27/02/201614/01/2016PSUSA/00002063/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

milrinoneN/A09/06/2016PSUSA/00002064/
201510
MaintenanceList of nationally authorised medicinal products
minoxidil (non topical formulations)N/A07/07/2016PSUSA/00002066/
201510
MaintenanceList of nationally authorised medicinal products
minoxidil (topical formulation)20/07/201607/07/2016PSUSA/00002067/
201510
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

misoprostol (gastrointestinal indication)N/A11/02/2016PSUSA/00010291/
201506
MaintenanceList of nationally authorised medicinal products

misoprostol (gynaecological indication - labor induction)

N/A14/01/2016PSUSA/00010353/
201505
MaintenanceList of nationally authorised medicinal products
misoprostol (gynaecological indication - termination of pregnancy)N/A14/01/2016PSUSA/00010354/
201505
MaintenanceList of nationally authorised medicinal products
montelukastN/A17/03/2016PSUSA/00002087/
201507
MaintenanceList of nationally authorised medicinal products

mycophenolic acid (apart from mycophenolate mofetil)

N/A07/07/2016PSUSA/00001731/
201511
MaintenanceList of nationally authorised medicinal products
nadroparinN/A03/12/2015PSUSA/00002104/
201503
MaintenanceList of nationally authorised medicinal products
nafarelinN/A08/10/2015PSUSA/00002105/
201502
MaintenanceList of nationally authorised medicinal products
naltrexoneN/A07/07/2016PSUSA/00002117/
201511
MaintenanceList of nationally authorised medicinal products
nicergolineN/A14/01/2016PSUSA/00002150/
201505
MaintenanceList of nationally authorised medicinal products
nifedipine27/04/201614/04/2016PSUSA/00002156/
201508
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to the product information and timetable for the implementation

niflumicN/A02/09/2016PSUSA/00002157/
201512
MaintenanceList of nationally authorised medicinal products
nimesulide (systemic formulations)N/A11/02/2016PSUSA/00009236/
201506
MaintenanceList of nationally authorised medicinal products
nimesulide (topical formulations)N/A11/02/2016PSUSA/00002165/
201506
MaintenanceList of nationally authorised medicinal products
nitrazepamN/A06/11/2015PSUSA/00002170/
201503
MaintenanceList of nationally authorised medicinal products
nitrendipineN/A03/12/2015PSUSA/00002171/
201503
MaintenanceList of nationally authorised medicinal products
nitrofurantoin / nifurtoinolN/A08/10/2015PSUSA/00002174/
201502
MaintenanceList of nationally authorised medicinal products
nomegestrolN/A08/10/2015PSUSA/00002181/
201501
MaintenanceList of nationally authorised medicinal products
ofloxacin (systemic use)16/12/201503/12/2015PSUSA/00002203/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

ofloxacin (topical use)N/A03/12/2015PSUSA/00002204/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

olodaterol

N/A14/04/2016PSUSA/00010245/
201509
MaintenanceList of nationally authorised medicinal products
olodaterolN/A08/10/2015PSUSA/00010245/
201503
MaintenanceList of nationally authorised medicinal products
ondansetron21/10/201508/10/2015PSUSA/00002217/
201502
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

oxaliplatin27/01/201614/01/2016PSUSA/00002229/
201504
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

pamidronate17/01/201614/01/2016PSUSA/00002269/
201505
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

paracetamol (IV formulation)N/A03/12/2015PSUSA/00002311/
201505
MaintenanceList of nationally authorised medicinal products
paracetamol / tramadol30/03/201617/03/2016PSUSA/00002310/
201508
Variation

List of nationally authorised medicinal products

CMDh scientific conclusions, amendments to product information and implementation timetable

paraffin liquidN/A13/05/2016PSUSA/00009251/
201510
MaintenanceList of nationally authorised medicinal products
perindopril22/06/201609/06/2016PSUSA/00002354/
201510
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

phenylephrineN/A10/09/2015PSUSA/00002378/
201501
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

phloroglucinol, phloroglucinol / trimethylphloroglucinolN/A13/05/2016PSUSA/00010355/
201509
MaintenanceList of nationally authorised medicinal products
pholcodineN/A14/01/2016PSUSA/00002396/
201505
MaintenanceList of nationally authorised medicinal products
pimecrolimus06/11/201506/11/2015PSUSA/00002411/
201503
MaintenanceList of nationally authorised medicinal products
piretanideN/A09/06/2016PSUSA/00002433/
201510
MaintenanceList of nationally authorised medicinal products
poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine 17/03/2016

PSUSA/00002460/
201507

MaintenanceList of nationally authorised medicinal products
potassium para aminobenzoateN/A08/10/2015PSUSA/00010130/
201502
MaintenanceList of nationally authorised medicinal products
pramiracetam25/06/201511/06/2015PSUSA/00002492/
201409
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to the product information and implementation timetable

promestriene (cream and vaginal capsules)N/A03/12/2015PSUSA/00009271/
201503
MaintenanceList of nationally authorised medicinal products
prulifloxacin24/06/201511/06/2015PSUSA/00002569/
201410
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

pseudoephedrine, triprolidineN/A10/09/2015PSUSA/00003047/
201412
MaintenanceList of nationally authorised medicinal products
rabbit anti-human thymocyte (concentrate for solution for infusion)N/A11/02/2016PSUSA/00010252/
201506
MaintenanceList of nationally authorised medicinal products
rabbit anti-human thymocyte (powder for solution for infusion)N/A11/02/2016PSUSA/00010184/
201506
MaintenanceList of nationally authorised medicinal products

rabbit anti-human thymocyte (powder for solution for infusion)

22/07/201509/07/2015PSUSA/00010184/
201412
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

rabbit anti-human thymocyte (concentrate for solution for infusion)N/A09/07/2015PSUSA/00010252/
201412
MaintenanceList of nationally authorised medicinal products
rabeprazoleN/A09/06/2016PSUSA/00002601/
201510
MaintenanceList of nationally authorised medicinal products
ranitidineN/A14/01/2106PSUSA/00002610/
201505
MaintenanceList of nationally authorised medicinal products
reboxetineN/A03/12/2015PSUSA/00002615/
201504
MaintenanceList of nationally authorised medicinal products
reviparinN/A10/09/2015PSUSA/00002634/
201501
MaintenanceList of nationally authorised medicinal products
ribavirin (aerosol application)N/A17/03/2016PSUSA/00010003/
201508
MaintenanceList of nationally authorised medicinal products
rilmenidine27/04/201614/04/2016PSUSA/00002643/
201508
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to the product Information and implementation timetable

roxithromycinN/A10/09/2015PSUSA/00002669/
201412
MaintenanceList of nationally authorised medicinal products
rubella vaccine (live, attenuated)N/A10/09/2015PSUSA/00002670/
201501
MaintenanceList of nationally authorised medicinal products
rupatadineN/A02/09/2016PSUSA/00002673/
201512
MaintenanceList of nationally authorised medicinal products
rupatadineN/A11/02/2016PSUSA/00002673/
201506
MaintenanceList of nationally authorised medicinal products
salmeterolN/A07/07/2016PSUSA/0002681/
201510
MaintenanceList of nationally authorised medicinal products
salmeterol / fluticasone propionateN/A11/06/2015PSUSA/00001455/
201410
MaintenanceList of nationally authorised medicinal products
rupatadineN/A02/09/2016PSUSA/00002673/
201512
MaintenanceList of nationally authorised medicinal products
sertindoleN/A02/09/2016PSUSA/00002695/
201601
MaintenanceList of nationally authorised medicinal products
sertindoleN/A11/02/2016PSUSA/00002695/
201507
MaintenanceList of nationally authorised medicinal products
sevofluraneN/A08/10/2015PSUSA/00002698/
201501
MaintenanceList of nationally authorised medicinal products
solifenacin/tamsulosinN/A11/02/2016PSUSA/00010285/
201507
MaintenanceList of nationally authorised medicinal products
spironolactone18/11/201506/11/2015PSUSA/00002780/
201503
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to the product Information and implementation timetable

sultamicillinN/A07/07/2016PSUSA/00002829/
201511
MaintenanceList of nationally authorised medicinal products
sumatriptanN/A11/06/2015PSUSA/00002832/
201409
MaintenanceList of nationally authorised medicinal products
tafluprostN/A14/01/2016PSUSA/00002843/
201504
MaintenanceList of nationally authorised medicinal products
tamoxifenN/A14/01/2016PSUSA/00002846/
201504
MaintenanceList of nationally authorised medicinal products
tapentadolN/A11/06/2015PSUSA/00002849/
201411
MaintenanceList of nationally authorised medicinal products
technetium (99mtc) mebrofenin20/07/201607/07/2016PSUSA/00002861/
201511
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to the product Information and implementation timetable

terlipressinN/A14/01/2016PSUSA/00002905/
201504
MaintenanceList of nationally authorised medicinal products
tenonitrozoleN/A08/10/2015PSUSA/00003185/
201502
MaintenanceList of nationally authorised medicinal products
tenoxicam18/12/201508/10/2015PSUSA/00002893/
201502
Variation

List of nationally authorised medicinal products
 

CMDh scientific conclusions, amendments to product information and implementation timetable

terazosinN/A07/07/2016PSUSA/00002895/
201511
Maintenance

List of nationally authorised medicinal products

testosterone undecylate (injection)22/07/201509/07/2015PSUSA/00010161/
201411
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

tetanus vaccinesN/A10/09/2015PSUSA/00002910/
201501
MaintenanceList of nationally authorised medicinal products
tetrabenazine24/06/201511/06/2015PSUSA/00002911/
201410
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

tetrabenazineN/A09/06/2016PSUSA/00002911/
201510
MaintenanceList of nationally authorised medicinal products
thiamphenicolN/A14/01/2016PSUSA/00002925/
201505
MaintenanceList of nationally authorised medicinal products
thiocolchicoside31/03/201617/03/2016PSUSA/00002927/
201507
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

tiagabineN/A11/02/2016PSUSA/00002942/
201506
MaintenanceList of nationally authorised medicinal products
tianeptineN/A11/02/2016PSUSA/00002943/
201506
MaintenanceList of nationally authorised medicinal products
tiaprideN/A17/03/2016PSUSA/00002944/
201507
MaintenanceList of nationally authorised medicinal products
ticlopidine27/01/201614/01/2016PSUSA/00002952/
20150
Variation

List of nationally authorised medicinal products
 

CMDh scientific conclusions, amendments to product information and implementation timetable

tiludronic acidN/A08/10/2015PSUSA/00002959/
201502
MaintenanceList of nationally authorised medicinal products
tizanidine23/09/201510/09/2015PSUSA/00002977/
201412
Variation

List of nationally authorised medicinal products
 

CMDh scientific conclusions, amendments to product information and implementation timetable

tobramycin (nebuliser solution)N/A10/09/2015PSUSA/00009316/
201412
MaintenanceList of nationally authorised medicinal products
topotecanN/A12/02/2016

PSUSA/00002997/
201505

MaintenanceList of nationally authorised medicinal products
trandolapril / verapamil18/11/201506/11/2015PSUSA/00003005/
201503
Variation

List of nationally authorised medicinal products
 

CMDh scientific conclusions, amendments to product information and implementation timetable

treprostinilN/A07/07/2016PSUSA/00003013/
201511
MaintenanceList of nationally authorised medicinal products
triamcinolone (intraocular formulations)N/A06/11/2015PSUSA/00010292/
201503
MaintenanceList of nationally authorised medicinal products
trimetazidineN/A17/03/2016PSUSA/00003043/
201508
MaintenanceList of nationally authorised medicinal products
urapidilN/A11/02/2016PSUSA/00003078/
201507
MaintenanceList of nationally authorised medicinal products
valaciclovirN/A02/09/2016PSUSA/00003086/
201512
MaintenanceList of nationally authorised medicinal products
valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpromide / valproate bismuth / calcium valproate / valproate magnesiumN/A10/09/2015PSUSA/00003090/
201501
Variation

List of nationally authorised medicinal products

 

CMDh scientific conclusions, amendments to product information and implementation timetable

vancomycinN/A08/10/2015PSUSA/00003097/
201501
MaintenanceList of nationally authorised medicinal products
vigabatrinN/A11/06/2015PSUSA/0003112/
201409
MaintenanceList of nationally authorised medicinal products
zafirlukastN/A02/09/2016PSUSA/00003138/
201512
MaintenanceList of nationally authorised medicinal products
ziprasidoneN/A17/03/2016PSUSA/00003146/
201507
MaintenanceList of nationally authorised medicinal products

How useful is this page?

Average rating:

 Based on 69 ratings

Add your rating:

See all ratings
11 ratings
5 ratings
7 ratings
15 ratings
31 ratings