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16 May 2023  
EMA/CVMP/206677/2023   
Committee for Veterinary Medicinal Products  
Opinion of the Committee for Medicinal Products for 
Veterinary Use on the establishment of maximum 
residue limits  
Procedure no: EMEA/V/MRL/003652/EXTN/0004  
Name of the substance: Ketoprofen (INN)  
Basis for the opinion  
Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Huvepharma NV submitted to 
the European Medicines Agency on 14 December 2020 an application for the extension of maximum 
residue limits for Ketoprofen to  chicken.  
On 12 May 2021 the Committee for Veterinary Medicinal Products adopted a list of questions to be 
addressed by the applicant. The response to the list of questions was submitted on 17 November 
2021.  
On 12 May 2022, the Committee for Medicinal Products for Veterinary Use  adopted an opinion 
recommendin g the extension of maximum residue limits for ketoprofen to chicken.  Furthermore , 
with reference to Article 5 of Regulation (EC) No 470/2009 and in line with the criteria laid do wn in 
Commission Regulation (EU) 2017/880 , the Committee agreed to extrapolate  the conclusions to 
poultry.  Four CVMP members did not support the recommendation for a “No MRL required” 
classification and signed a divergent position.  
On 1 March 2023 the European Commission requested the Committee to reconsider its opinion of 1 2 
May 2022 with a view to further examining the issues identified  in the divergent opinion and 
indicated that if the proposed “No MRL required” status for poultry could not be further 
substantiated, then the CVMP is requested to recommend numerical MRLs for ketoprofen in chicken 
tissues.  
Recommendation  
The Committee, having considered the application , having evaluated the response to the list of 
questions  and having considered  the letter from the Commission , recommends the extension of 
maximum residue limits for ketoprofen  to chicken  in accordance  with the table below . Furthermore, 
with reference to Article 5 of Regulation (EC) No. 470/2009 and in line with the criteria laid down in  
  
Opinion  of the Committee for Medicinal Products for Veterinary Use on  the establishment of maximum residue limits   
EMA/CVMP/206677/2023  Page 2/12 Commission Regulation (EU) 2017/880, the Committee agreed to extrapolate the c onclusions to 
poultry. Therefore, the amendment of the entry for ketoprofen in table 1 of the Annex to Regulation 
(EU) No 37/2010 of 22 December 2009, is recommended as follows : 
 
Pharmaco -
logically 
active 
substance  Marker 
residue  Animal 
species  MRLs  Target  tissues  Other 
provisions  Therapeutic 
classification  
Ketoprofen  
 Ketoprofen  Bovine, 
porcine, 
Equidae  No MRL 
required  NOT 
APPLICABLE  NO ENTRY  NO ENTRY  
Poultry  10 µg/kg  
30 µg/kg  
 
 
10 µg/kg  
10 µg/kg  Muscle  
Skin and fat in 
natural 
proportion  
Liver 
Kidney  Not for use in 
animals from 
which eggs 
are produced 
for human 
consumption  NO ENTRY  
 
The Norwegian  CVMP member agrees  with the above -mentioned recommendation of the Committee.  
The scientific conclusions of the Committee are presented in the European public MRL assessment  
report (EPMAR), provided in Annex I of this opinion.  
The present opinion is forwarded to the European Commission and to the applicant together with its 
appendices.   
 Annex I  
  
 
 
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EMA/CVMP/153263/2023  Page 4/12 
 
 Revised European public MRL assessment report 
(EPMAR)  
Ketoprofen ( Poultry ) 
 Summary of the scientific discussion for the establishment of 
MRLs  
Substance name:  Ketoprofen  
Therapeutic class:  Nonsteroidal anti-inflammatory agents  
Procedure number:  EMEA/V/MRL/003652/EXTN/0004  
Applicant:  Huvepharma NV  
Target species  applied for : Chicken  
Intended therapeutic indication:  Treatment of inflammatory and painful conditions  
Route(s) of administration:  Oral 
 
1.  Introduction  
Ketoprofen is a non -steroidal anti -inflammatory drug belonging to the arylpropionic acid group. It is 
used in human and veterinary medicine for its anti -inflammatory, analgesic and antipyretic 
activities. It is indicated for inflammatory and p ainful conditions of the bones, joints and muscular -
skeletal systems in cattle, horses, dogs and cats, for alleviation of pain associated with colic in 
horses and cattle, for reducing pyrexia and respiratory rate in case of respiratory infections in pigs 
and as supportive treatment of mastitis -metritis -agalactia syndrome in the sow. The dose in food 
producing species is 2 to 3 mg/kg bw by intravenous or intramuscular route.  
Ketoprofen was previously assessed by the CVMP and a toxicological ADI of 5  µg/kg  bw, i.e. 
0.3 mg/person was established.  
Currently ketoprofen is included in Table 1 of the Annex to Commission Regulation (EU) No 37/2010 
of 22 December 2009 in accordance with the following table:  
Pharmaco -
logically 
active 
substance  Marker 
residue  Animal species  MRLs  Target 
tissues  Other 
provisions  Therapeutic 
classification  
Ketoprofen  
 NOT 
APPLICABLE  Bovine, porcine, 
Equidae  No MRL 
required  NOT 
APPLICABLE  NO ENTRY  NO ENTRY  
 
Huvepharma N.V. submitted an application for the extension of MRLs for ketoprofen  to chicken on 14 
December 2020. Ketoprofen is intended for use in chickens for the treatment of inflammatory and 
painful conditions at an oral dose of 10  mg/kg  bw/day for 5 days, administered in drinking water.  
Based on its evaluation of the data submitted by the Huvepharma N.V., the Committee adopted an 
opinion on 1 2 May  2022 recommending the extension of maximum residue limits for ketoprofen to 
chicken  and considered that  the establishment of numerical MRLs for ketoprofen  in chicken  tissues  is  
 
 
Revised European public MRL assessment report (EPMAR)    
EMA/CVMP/153263/2023  Page 5/12 
 
 not necessary for the protection of human health. Furthermore, with reference to Article 5 of 
Regulation (EC) No 470/2009 and in line with the criteria laid down in Commission Regulation (EU) 
2017/880, the Committee agreed to extrapolate the conclusions  to poultry. Four CVMP members did 
not support the recommendation for a “No MRL required” classification and signed a divergent 
position.  
The CVMP opinion was considered by the Standing Committee on Veterinary Medicinal Products at its 
meeting on 31 Januar y 2023. As a result of the concerns raised by CVMP members in the 
aforementioned divergent position the Standing Committee was unable to support the CVMP opinion.  
On 1 March 2023 the European Commission  requested the CVMP to reconsider its opinion with a v iew 
to further examining the issues identified  in the divergent opinion and indicated that if the proposed 
“No MRL required” status for poultry could not be further substantiated, then the CVMP is requested 
to recommend numerical MRLs for ketoprofen in chi cken tissues.  
The specific issues highlighted in the Commission’s request to reconsider the CVMP opinion were 
drawn from the divergent position and related to:  
1. the presence of an unidentified new metabolite (metabolite B) of ketoprofen in chicken tissue s 
that, as stated in the divergent opinion, could pose a concern as it seems to make up  a significant 
part of the total residue value (in some cases >10% and more than 100 μg/kg).  
2. residue concentrations in tissues from the target population, that may e xceed the ADI when 
metabolite B is taken into account and assuming that the metabolite has (at least) the same 
pharmacological and toxicological activity as ketoprofen. Furthermore, the divergent opinion noted 
that the two other major metabolites A and C ( supposedly hydroxylated metabolites of ketoprofen) 
have not been fully identified/characterised either.  
The divergent position argued that these metabolites should also be considered for consumer 
exposure , i.e. assuming the same toxicological and pharmacol ogical activity as ketoprofen.  
Furthermore, it was noted that, as highlighted in the divergent position, ‘No MRL required’ substances 
are normally not included in residue control programs and therefore no monitoring of the possible 
occurrence of residues a nd the associated risk for consumers is performed. Any other legal use or 
inappropriate use of the VMP potentially leading to higher residues would not or would only 
exceptionally come to light and could lead to public health concerns.  
2.  Scientific risk asse ssment   
This scientific risk assessment is based on the previous safety assessment carried out by the CVMP, 
and on new data in relation to the residues of ketoprofen in chickens. The data in relation to the 
safety of ketoprofen (i.e. pharmacological and to xicological data) have not been re -assessed.  
2.1.  Safety assessment  
The CVMP has previously assessed the consumer safety of ketoprofen and established an overall 
ADI of 0.005  mg/kg  bw, i.e. 0.3  mg/person, based on the BMDL5 of 0.04  mg/kg  bw/day for kidney 
lesions in rats and a chemical specific uncertainty factor of 7.6.  
No further assessment regarding the consumer safety of the substance is required for the purpose 
of this extension application.   
 
 
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 2.2.  Residues assessment  
Only residues data that are relevant to this MRL -extension application to chickens are presented 
here. 
2.2.1.  Pharma cokinetics in target species  
In a published study on the pharmacokinetic properties of ketoprofen in broiler chickens using 
intravenous and oral administration, both enantiomers of ketoprofen showed a fast but incomplete 
absorption from the gastrointestina l tract, with an absolute oral bioavailability of 31.5% and 52.6% 
for R(-) and S(+) ketoprofen, respectively. Ketoprofen showed a limited distribution and was rapidly 
eliminated.  
In a radiolabel study, [14C]-ketoprofen was given in gelatine capsules to mal e and female Ross 
broiler chickens at a dose of 10 mg/kg bw/day for 5 days. The animals were slaughtered in groups 
at 1, 3, 6, 24, 48, and 72 hours after cessation of treatment. The total radioactive residue (TRR) in 
edible tissues (liver, kidney, muscle a nd fat plus skin) was quantified, as well as the concentration 
of ketoprofen and its main metabolite 2 -[3-(alphahydroxybenzyl) phenyl]propanoic acid (referred to 
as OH -ketoprofen or RP 69400). The highest TRR concentrations were found in kidney, followed b y 
liver and fat plus skin. Total residues in muscle were very low and only detectable up to 6 hours , 
with approximate mean residues of TRR (as µg ketoprofen equivalents per kg) of 80 and 40 at 3 and 
6 hours , respectively . The approximate mean residues of T RR (as µg ketoprofen equivalents per kg) 
at 1, 3, 6  and 72 hours were 15700 , 8420, 4600  and 1300 in kidney, 3750 , 1970, 1080  and 330 in 
liver, and 1100 , 770, 730  and 480 in fat plus skin. The approximate mean marker to total residue 
ratios at 3 hours were 0.37, 0.11, 0.13 and 0.05 and at 6 hours were 0.04, 0.03, 0.02, 0.003 for 
muscle, fat plus skin, liver and kidney, respectively. Ketoprofen was rapidly and extensively 
metabolised into OH -ketoprofen, into two further hydroxylated ketoprofen forms, and into  other 
unknown metabolites. Ketoprofen and its hydroxylated forms were only detected during the first 6 
hours in all tissues, with the exception of fat plus skin, where low levels of ketoprofen were detected 
up to 48 hours. One unidentified metabolite (“me tabolite B”) persisted longer and represented more 
than 10% of the radioactivity in most samples  at later time points . This metabolite was 
characterised as very hydrophilic, and probably consisted of several  compounds. Its 
chromatographic behaviour was inc onsistent with known glucuronides of ketoprofen. It was 
concluded that metabolite B consisted of a number of very polar downstream metabolites with no 
structural resemblance to parent ketoprofen, and therefore without pharmacological activity. In an 
additi onal study with unlabelled ketoprofen given in the drinking water at a dose of 
20 mg/kg  bw/day for 5 days to Ross and Sasso broilers, metabolite B was not found. In this latter 
study, the main residues  were parent ketoprofen, OH -ketoprofen, and the two afo rementioned other 
hydroxylated forms.  
2.2.2.  Residue depletion studies  
Depletion in tissues  
In a cold residue depletion study, nine male and nine female broiler chickens were given ketoprofen 
in the drinking water at a target dose of 10  mg/kg  bw/day for 5 consecutive days. Groups of 3 
males and 3 females were slaughtered at 3, 12, and 24 hours after the cessation of treatment. 
Samples of liver, kidney, muscle, and fat plus skin were taken and analysed for ketoprofen and OH - 
 
 
Revised European public MRL assessment report (EPMAR)    
EMA/CVMP/153263/2023  Page 7/12 
 
 ketoprofen using a validated UHPLC -MS/MS method with an LOQ of 10  µg/kg in all tissue matrices. 
The metabolite OH -ketoprofen was not found in any tissue at any timepoint. At 3 hours, ketoprofen 
was found in all fat plus skin samples (11.6 – 45.9 µg/kg) and 1 out of 6 kidney samples 
(11.6  µg/kg). At 12 and 24  hours, ketoprofen was only found in fat plus skin (2/6 samples at both 
time points, range 10.3  – 21.5 µg/kg).  
The levels of ketoprofen in this study were lower t han in the ADME study (see 2.2.1), that used the 
same oral dose and duration, although the method of administration was different (gavage versus 
drinking water). In addition, at 3 hours, the levels in liver and kidney were respectively 3 and 5 
times higher  than in fat plus skin in the ADME study, whereas in this cold study the levels in fat plus 
skin were highest at this timepoint. An additional study was performed to explain these differences. 
The results of this study show that parent ketoprofen  concentra tions in the target tissue fat plus 
skin are highest and also comparable for both administration methods  (i.e. by gavage and in 
drinking water) . However, in the other tissues, in liver and kidney in particular, the residue 
concentrations following gavage a re 3-4 times higher than with drinking water administration, albeit 
that this is largely based on residue concentrations between LOD and LOQ. The difference is 
explained by the fact that continuous exposure via drinking water results in a steady state, whe reas 
short peak concentrations occur at approximately 6 hours after each gavage administration. This is 
not the case for fat  plus skin, because of the longer retention in this tissue which causes 
accumulation. It can be concluded that the data from animals  treated via drinking water are more 
representative for the field situation and should be considered in the establishment of MRLs.  
Depletion in eggs  
No residue depletion data were provided for ketoprofen in eggs from treated layer chickens.  
Selection of m arker residue and ratio of marker to total residues  
In its opinion of 12 May 2022 the Committee considered that n o MRLs were required for ketoprofen 
in chicken tissues and there was no need to identif y a marker residue. For the risk assessment, the 
parent substance ketoprofen was considered the relevant residue of concern, because it is the only 
substance that contributes significantly to the pharmacological activity of the incurred residues in 
chicken tissues.  
Ketoprofen has a toxicological ADI of 0.005  mg/kg bw, i.e. 0.3  mg/person, based on the BMDL5 of 
0.04 mg/kg  bw/day for kidney lesions in rats and a chemical specific uncertainty factor of 7.6  (as 
described in European Public MRL Assessment Report EMA/CVMP/94885/2020) . In case of a 
toxicological ADI, it  is often assumed that the total residue is the relevant residue for the risk 
assessment, because it is usually not known whether metabolites could have contributed to the 
toxicological effect. However, in the case of ketoprofen, the kidney lesions can be explained by the 
pharmacological mode of action, i.e. its binding to the cyclooxygenase receptor: COX inhibition 
leads to lower prostaglandin levels; prostaglandins are important mediators of renal vascular tone 
and sodium balance resulting in natriuresis because of both vasodilatory action and inhibition of Na+ 
reabsorption (Rios et al.,  20121). Therefore, in its opinion of 12 May 2022 , the Committee 
considered that the relevant residue for consumer risk assessment was the residue with 
pharmacological activity , i.e. the parent compound . 
                                                
1 Rios, A., Vargas -Robles, H., Gámez -Méndez, A. M., & Escalante, B. (2012). Cyclooxygenase -2 and kidney failure. 
Prostaglandins & other lipid mediators, 98(3 -4), 86 -90.  
 
 
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 Following the request from the European Commission dated 1 March 2023 and h aving reflected on 
the concerns raised in the request, the Committee confirmed its original position that ketoprofen, as 
the residue with pharmac ological activity, is the appropriate marker residue for monitoring. 
However, in line with the concerns raised in the divergent position the calculation of consumer 
intake of residues will take account of total residues, i.e. it will include all metabolite s and 
consequently a ratio of marker to total residues is established. From the radiolabel study data, 
where ketoprofen was administered  in gelatine capsules , the following ratios of marker to total 
residues of 0.043, 0.031, 0.02, 0.003 for muscle, fat plu s skin, liver and kidney observed 6 hours 
after treatment were retained. The ratios of marker to total residues at 6 hours are considered to be 
sufficiently conservative for the purpose of consumer safety.  
2.2.3.  Monitoring or exposure data  
No relevant monitoring  or exposure data other than that described elsewhere in this report were 
available.  
2.2.4.  Analytical method for monitoring of residues  
A UHPLC -MS/MS  method has been developed and validated for the determination of ketoprofen and 
OH-ketoprofen in muscle, skin pl us fat, liver and kidney of chickens. This method was used in the 
residue studies described above. The method is presented in an internationally recognized format 
and has been validated in line with the current requirements of VICH Guideline 49. The method  was 
sufficiently validated in the range of 10 – 1500 µg/kg.  
Following the request from the European Commission dated 1 March 2023 and h aving reflected on 
the issue, the Committee reconsidered the available analytical method in view of the proposal to 
establish numerical MRLs (see section 3.2 below).  The Committee concluded that the method can 
be considered appropriately validated. The relevant EURL has reviewed the method and is in 
agreement with this conclusion.  
2.2.5.  Potential effects on the microorganisms us ed for industrial food 
processing  
As the substance is not expected to possess antimicrobial activity no effects on microorganisms 
used for industrial food processing are expected.  
2.2.6.  Findings of EU or international scientific bodies  
Ketoprofen has not been ev aluated for this purpose by EU or international scientific bodies.   
 
 
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 3.  Risk management recommendations  
3.1.  Availability of alternative medicines and other legitimate factors  
Availability of alternative medicines  
At present, no oral NSAIDs are available for chickens.  
Conditions of use  
In the absence of residue data for eggs the use of ketoprofen should be restricted to animals not 
producing eggs for human consumption.  
3.2.  Elaboration of MRLs  
Calculation of the theoretical daily intake of residues  
In its opinion o f 12 May 2022 the CVMP considered the following.  
The highest tissue concentrations of parent ketoprofen (the residue of concern) were found at 3 
hours after cessation of dosing in the pivotal residue depletion study in chickens treated via drinking 
water a t the recommended dose and duration . Residues in muscle and liver were below the LOQ 
(10 µg/kg). Taking the highest residue levels seen at this timepoint the theoretical maximum 
consumer intake of residues of concern is calculated using the standard food b asket:  
Tissue  Maximum 
concentration of 
ketoprofen (µg/kg)  Daily consumption 
(kg) Intake (µg/day)  
Muscle  - 0.3 - 
Fat + skin  45.9 0.09 4.131  
Liver - 0.1 - 
Kidney  11.6 0.01 0.116  
Total   4.274  
Based on the above intake calculation the maximum intake of toxicologically relevant residues 
represents only 1.4% of the ADI. Even if residue levels at the LOQ in muscle and liver are factored 
into the calculation the intake calculation remains below 3% o f the ADI . Therefore, in line with 
Commission Regulation (EU) 2018/782, it was concluded that the establishment of numerical MRLs 
is not needed for the protection of human health.  
In its letter  of 1 March 2023, the European Commission requested a review of  the CVMP opinion 
with a view to further examining the issues identified  in the divergent opinion and, if the proposed 
“No MRL required” status for poultry cannot be further substantiated, t o recommend numerical MRLs 
for ketoprofen in chicken tissues . 
Having reflected on the specific request of the European Commission, and noting the absence of 
additional data to substantiate the proposed “No MRL required” status for poultry (that is, in the  
 
 
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 absence of additional characterisation of metabolites A, B and C, further justification as to why the 
parent compound ketoprofen is considered the only relevant residue with pharmacological activity 
cannot be provided), the Committee decided to recommend numerical MRLs. Based on the available 
residue depletion data, and the ratios of marker to total residues at 6 hours , the following  MRLs can 
be proposed:  
Muscle, liver and kidney: 10 µg/kg  
Skin and fat in natural proportions: 30 µg/kg  
The calculation of the theoretical daily intake of residues is as follows:  
Edible tissue  or 
products  Daily 
consumption 
(kg) MRL proposal 
(µg/kg)  Ratio of the 
marker/total 
residue  Amount per edible 
tissue or product  
Muscle  0.30 10 0.0426  70.4 
Fat  0.09 # 30 0.0313  86.3 
Liver 0.10 10 0.0195  51.3 
Kidney  0.01 10 0.0034  29.4 
# fat and skin in natural proportion  
Based on the above figures the maximum theoretical consumer intake is 237.4 µg, representing 
79.1% of the ADI (of 300 μg/person). This calculation takes account of all residues and assumes that 
all metabolites possess the same pharmacological/toxicological activity as the parent substance.  
Exposure to residues may also take place as a result of consumption of milk. Previously evaluated 
data (reported in European Public MRL Assessment Report EMA/CVMP/94885/2020) indicate that 
ketoprofen residues were not detected in milk. Using the limit of detection of 25 μg/L to estimate 
potential worst -case exposure to residues via milk results in an intake value of 37 μg per person. 
When added to the intake from poultry tissues this represents  91% of the ADI , which leaves limited 
room for potential future uses of the substance . 
4.  Considerations on possible extrapolation of MRLs  
In line with Article 5 of Regulation (EC) No 470/2009, the CVMP considered the possibility of 
extrapolating the maximum residue limits recommended for ketoprofen to other food producing 
species and commodities. Taking into account the provisions laid down in Commission Regulation 
(EU) 2017/880, and current scientific knowledge, the recommendations on extrapolation are 
justified as follows:  
Animal species/ 
food 
commodities  Extrapolation 
possible 
(Yes/No)  Justification  
Poultry eggs  No According to article 7(f) of Commission Regulation (EU) 
2017/880, extrapolation of MRLs from poultry tissues to 
poultry eggs shall not be carried out.  
Poultry species 
other than 
chickens  Yes In accordance with Commission Regulation (EU) 2017/880, 
an MRL can be extrapolated from a major species to a 
related species where the parent substance is the marker  
 
 
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 residue in the reference species. As  such, the MRL 
recommendation for chickens should be extrapolated to 
poultry.   
5.  Conclusions and recommendation for the establishment 
of maximum residue limits  
Having considered that:  
 the toxicological ADI of 0.005  mg/kg  bw (i.e. 0.3  mg/person) was established as the overall ADI 
for ketoprofen,  
 oral administration of ketoprofen resulted in a fast absorption, limited distribution, and fast 
depletion,  
 ketoprofen is extensively metabolised in chickens following oral administration,  
 the calculated consumer intake of residues of ketoprofen from chicken tissues always remains 
well below the ADI,  
 extrapolation from chicken to all poultry species is appropriate,  
 with a view to facilitating official residue control activities numerical MRLs are recommend ed, 
 ketoprofen is retained as the marker residue,  
 the ratios of marker to total residues at 6 hours were 0.043 in muscle, 0.031 in fat plus skin, 0.02 
in liver and 0.003 in kidney,  
 an appropriately validated analytical method for the determination of ketop rofen in chicken 
tissues is available , 
the Committee recommends the extension of maximum residue limits for  ketoprofen to chicken. 
Furthermore, with reference to Article 5 of Regulation (EC) No 470/2009 and in line with the criteria 
laid down in Commission  Regulation (EU) 2017/880, the Committee recommends the extrapolation 
of maximum residue limits for ketoprofen to poultry species and the amendment of the entry  for 
ketoprofen in table 1 of the Annex to Commission Regulation (EU) No 37/2010 as follows:  
Pharmaco -
logically 
active 
substance  Marker 
residue  Animal 
species  MRLs  Target tissues  Other 
provisions  Therapeutic 
classification  
Ketoprofen  
 Ketoprofen  Bovine, 
porcine, 
Equidae  No MRL 
required  NOT 
APPLICABLE  NO ENTRY  NO ENTRY  
Poultry  10 µg/kg  
30 µg/kg  
 
10 µg/kg  
10 µg/kg  Muscle  
Skin and fat in 
natural 
proportion  
Liver 
Kidney  Not for use in 
animals from 
which eggs are 
produced for 
human 
consumption  NO ENTRY  
The theoretical intake of residues from chicken tissues represents less than 80 % of the ADI.   
 
 
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6.  Background information on the procedure  
Submission of the dossier  14 December 2020  
Steps taken for assessment of the substance  
 Application validated:  12 January 2021  
 Clock started:  13 January 2021  
 List of questions adopted:  12 May 2021  
 Consolidated response to list of questions submitted:  19 November 2020  
 Clock restarted:  22 November 2020  
 List of outstanding issues adopted:  20 January 2022  
 Oral explanation provided by applicant:  11 April 2022  
 Consolidated response to the list of outs tanding issues  12 April 2022  
 Clock restarted:  13 April 2022  
 CVMP opinion adopted:  12 May 2022  
 Commission request for reconsideration of opinion:  1 March 2023  
 Revised CVMP opinion adopted:  16 May 2023