Supemtek

1 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I  
 

SUMMARY OF PRODUCT CHARACTERISTICS  



2 
 

This medicinal product is subject to additional monitoring. This will allow quick identification 
of new safety information. Healthcare professionals are asked to report any suspected adverse 
reactions. See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Supemtek solution for injection in pre-filled syringe 
 
Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

One dose (0.5 mL) contains: 
Influenza virus haemagglutinin (HA) proteins, of the following strains*: 
 
A/XXXXXX (H1N1).................................. 45 micrograms HA 

A/XXXXXX (H3N2).................................. 45 micrograms HA 

B/XXXXXX ............................................... 45 micrograms HA 

B/XXXXXX ............................................... 45 micrograms HA 

 
* produced by recombinant DNA technology using a baculovirus expression system in a 
continuous insect cell line that is derived from Sf9 cells of the fall armyworm, Spodoptera 
frugiperda. 
 
This vaccine complies with the World Health Organization (WHO) recommendation (Northern 
Hemisphere) and EU recommendation for the XXXX/XXXX season. 
 
Supemtek may contain traces of octylphenol ethoxylate. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection in pre-filled syringe (injection). 

Clear and colourless solution.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Supemtek is indicated for active immunization for the prevention of influenza disease in adults.  
 
Supemtek should be used in accordance with official recommendations. 
 



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4.2 Posology and method of administration 
 
Posology: 

One dose of 0.5 mL. 
 
Paediatric population 
Safety and efficacy of Supemtek have not yet been established in individuals below 18 years of age.  
 
Method of administration: 

For intramuscular injection only. The preferred site is in the deltoid muscle. 
The vaccine must not be injected intravascularly and must not be mixed with other vaccines in the 
same syringe. 
 
For instructions on the handling of the vaccine before administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 or to any trace 
residuals such as octylphenol ethoxylate. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
In order to improve the traceability of biological medicinal products, the name and the batch 
number of the administered product should be clearly recorded. 

Hypersensitivity 
Appropriate medical treatment and supervision should always be readily available in case of an 
anaphylactic event following the administration of the vaccine. 

Intercurrent illness 
Vaccination should be postponed in patients with acute febrile illness until the fever is resolved. 

Immunodeficiency 
Antibody response in patients with endogenous or iatrogenic immunosuppression may be 
insufficient to prevent influenza. 

Thrombocytopenia and coagulation disorders 
As with all injectable vaccines, Supemtek must be administered with caution to individuals with 
thrombocytopaenia or a bleeding disorder since bleeding may occur following an intramuscular 
administration to these subjects. 
 
Syncope 
Syncope can occur following or even before any vaccination as a psychogenic response to the 
needle injection.This can be accompanied by several neurological signs such as transient visual 
disturbance, paraesthesia and tonic-clonic limb movements during recovery. Procedures should be 
in place to prevent falling and injury and to manage syncope. 

Protection 
As with any vaccine, vaccination with Supemtek may not protect all vaccinees. 

Sodium content 



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This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say is 
essentially “sodium free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed, nor data to assess the concomitant administration of 
Supemtek with other vaccines. 
If Supemtek is to be given at the same time as another injectable vaccine, the vaccines should 
always be administered at different injection sites. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There is a limited amount of data from the use of Supemtek in pregnant women. 
One animal study performed with trivalent recombinant influenza vaccine did not indicate direct or 
indirect harmful effects with respect to pregnancy, embryo-foetal development or early post-natal 
development. 
An assessment of the risks and benefits should be performed by a health care professional before 
administering Supemtek to a pregnant woman. 
 
Breast-feeding 
It is not known whether Supemtek vaccine is excreted in human milk. 
An assessment of the risks and benefits should be performed by a health care professional before 
administering Supemtek to a breast-feeding woman. 
 
Fertility 
No human fertility data are available. 
The animal study with trivalent recombinant influenza vaccine did not indicate harmful effects on 
female fertility. 
 
4.7 Effects on ability to drive and use machines 
 
Supemtek has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile  

Supemtek has been administered to and safety data collected from 998 adults 18-49 years of age 
(Study 1) and 4328 adults 50 years of age and older (Study 2).  
The most common reactions occurring after vaccine administration were injection-site reactions 
(tenderness and pain) reported overall by 48% and 37% of study participants 18-49 years of age 
receiving Supemtek respectively. In study participants 50 years of age and older, injection site 
tenderness was reported by 34% and injection site pain reported by 19%. 
The severity of the reactions was mild to moderate. Onset usually occurred within the first 3 days 
after vaccination. All resolved without sequelae. 
 
Tabulated list of adverse reactions 

The adverse reactions are listed by MedDRA system organ class under headings of frequency using 
the following convention:  
Very common (≥1/10);  
Common (≥1/100 to <1/10);  



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Uncommon (≥1/1,000 to <1/100);  
Rare (≥1/10,000 to <1/1,000);  
Very rare (<1/10,000);  
Frequency not known (adverse reactions from post-marketing experience; cannot be estimated from 
the available data). Within each frequency grouping, adverse reactions are presented in the order of 
decreasing seriousness. 
 
Table 1: Adverse reactions reported following vaccination in adults 18 years and older during 
clinical trials and post-marketing surveillance 

MedDRA 
System Organ 
class 

Very common 
(≥1/10) 

Common 
(≥1/100 to 
<1/10) 

Uncommon 
(≥1/1,000 to 
<1/100) 

Rare 
(≥1/10,000, 
<1/1,000) 

Frequency not 
known 

Immune system 
disorders   

  Hypersensitivity 
including 
anaphylactic 
reaction 

Nervous system 
disorders 

Headache, 
Fatigue    

 Dizziness(4,6) Guillain-Barré 
syndrome7 

Respiratory, 
thoracic and 
mediastinal 
disorders 

  

Cough,  
Oropharyngeal 
pain 
 

  

Gastrointestinal 
disorders  Nausea 

Diarrhoea(4)   

Skin and 
subcutaneous 
tissue disorders 

  
Pruritus(2,4) , 
Dermatitis(4,5), 
Rash(4,5) 

Urticaria(4,6)  

Musculoskeletal 
and connective 
tissue disorders 

Myalgia(1), 
Arthralgia(1)  

   

General 
disorders and 
administration 
site conditions 

Local 
tenderness,  
Local pain 

Firmness / 
Swelling, 
Redness, Fever 
(2,3), Shivering 
/ Chills,  

Flu-like 
symptoms(4,6), 
Injection site 
pruritus(4) 

  

(1) Common in adults 50 years of age and older. 
(2) Rare (≥1/10,000 to <1/1,000) in adults 50 years of age and older. 
(3) ≥38.0°C (100.4°F). 
(4) Reported as unsolicited adverse reaction. 
(5) Not reported in adults 50 years of age and older. 
(6) Not reported in adults 18-49 years of age. 
(7) Reported from post-marketing surveillance, no causal relationship established. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 



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 No cases of overdose reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccine, ATC code: J07BB02 
 
Immunogenicity 

Supemtek was evaluated in healthy adults of 18-49 years of age in a randomized, observer-blind, 
active controlled, non-inferiority immunogenicity, multi-center trial conducted during the 2014-
2015 influenza season in the United States (study 1).  
In the study 1, subjects received Supemtek (N=998) or an egg-based quadrivalent inactivated 
influenza vaccine (IIV4) (N=332). Immunogenicity was assessed before and 28 days after 
administration of a single dose of study vaccine. 

Haemagglutination inhibition (HAI) geometric mean titers (GMTs) were determined for the two 
vaccine groups for each vaccine antigen. Immunogenicity was compared by calculating the 
difference in seroconversion rates (SCR) and the ratios of GMTs of Comparator to Supemtek.  

Study 1 had two co-primary endpoints: GMTs and Day 28 HAI seroconversion rates for each of the 
four antigens contained in the study vaccines.  

Supemtek met the success criterion for GMTs for three of the four antigens but did not meet the 
success criteria for the B/Victoria lineage antigen (Table 2). Antibody titres against the B/Victoria 
were low in both vaccine groups. 
 
Table 2: Comparison of Day 28 Post-Vaccination Geometric Mean Titers (GMT) for 
Supemtek and Comparator in Adults 18-49 Years of Age, Study 1 (Immunogenicity 
Population) 1,2,3  

Antigen Post-vaccination GMT Supemtek N=969 
Post-vaccination GMT 
Comparator N=323 

GMT Ratio 
Comparator/ 
Supemtek (95% CI)

A/H1N1 493 397 0.81 (0.71, 0.92)
A/H3N2 748 377 0.50 (0.44, 0.57)
B/Yamagata 156 134 0.86 ( 0.74, 0.99)
B/Victoria 43 64 1.49 (1.29, 1.71)

Abbreviations: CI, confidence interval; GMT, geometric mean titer.  
1 HI titers were assayed using egg-derived antigens. 
2 Comparator: egg-based quadrivalent inactivated influenza vaccine. 
3 Success in meeting the GMTs endpoint was pre-defined as an upper bound (UB) of the two-sided 95% CI of 
GMTComparator / GMT Supemtek ≤ 1.5. 
 
Supemtek met the success criterion for SCRs for three of the four antigens (Table 3), but not for the 
B/Victoria lineage. The HAI response to the B/Victoria lineage antigen was low in both vaccine 
groups. 
 



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Table 3: Comparison of Day 28 Seroconversion Rates for Supemtek and Comparator in 
Adults 18-49 Years of Age, Study 1 (Immunogenicity Population) 1,2,3,4 

Antigen SCR (%, 95% CI) Supemtek N=969 
SCR (%, 95% CI) 
Comparator N=323 

SCR Difference (%) 
Comparator - 
Supemtek [95% CI]

A/H1N1 66.7 (63.6, 69.6) 63.5 (58.0, 68.7) -3.2 (-9.2, 2.8) 
A/H3N2 72.1 (69.2, 74.9) 57.0 (51.4, 62.4) -15.2 (-21.3, -9.1)
B/Yamagata 59.6 (56.5, 62.8) 60.4 (54.8, 65.7) 0.7 (-5.4, 6.9) 
B/Victoria 40.6 (37.4, 43.7) 58.2 (52.6, 63.6) 17.6 (11.4, 23.9) 

Abbreviations: CI, confidence interval; SCR, seroconversion rate  
1 HI titers were assayed using egg-derived antigens.  
2 Comparator was an egg-based quadrivalent inactivated influenza vaccine. 
3 Seroconversion was defined as either a pre-vaccination HAI titer of <1:10 and a post-vaccination HAI titer of ≥1:40, or a 
pre-vaccination HAI titer of ≥1:10 and a minimum 4- fold rise in post vaccination HAI titer, at Day 28. 
4 Success in meeting the seroconversion rate (SCR) endpoint was pre-defined as an upper bound (UB) of the two-sided 
95% CI of SCR Comparator – SCR Supemtek ≤10%. 
 
The study 1 in adults 18-49 years of age was conducted in parallel to the study 2 in adults of 
50 years of age and older. These adults 18-49 years of age were vaccinated during the same 
influenza season (2014-2015 Northern Hemisphere influenza season) and received the same 
Supemtek formulation (same vaccine strain composition) as adults of 50 years of age and older in 
the study 2. The immune response induced by Supemtek was assessed by the same HAI assay and 
performed by the same laboratory for both studies.  The immunogenicity results in adults 18-49 
years of age (study 1) and adults 50 years of age and older (study 2) are presented in table 4.  
 
Table 4: Summary of HAI Antibody Response to Supemtek for Each Strain in Adults 18-
49 years (Study 1) and Adults≥50 years (Study 2) - Immunogenicity Analysis Set 

 Adults 18-49 years N=969 
Adults ≥50 years 
N=314 

GMT post-vaccination (95% CI)   

A/California/7/2009 (H1N1) 493 (460; 527) 190 (164; 221)
A/Texas/50/2012 (H3N2) 748 (700; 800) 522(462; 589) 
B/Massachusetts/02/2012 (Yamagata 
lineage) 156 (145; 168) 55 (48; 64) 

B/Brisbane/60/2008 (Victoria lineage) 43 (40; 46) 29 (26; 33) 

SCR % (95% CI)   

A/California/7/2009 (H1N1) 66.7 (63.6; 69.6) 44.9 (39.3; 50.6)
A/Texas/50/2012 (H3N2) 72.1 (69.2; 74.9) 54.5 (48.8; 60.1)
B/Massachusetts/02/2012 (Yamagata 
lineage) 59.6 (56.5; 62.8) 38.9 (33.4; 44.5) 

B/Brisbane/60/2008 (Victoria lineage) 40.6 (37.4; 43.7) 21.0 (16.6; 25.9)
GMTR % (95% CI)   
A/California/7/2009 (H1N1) 8.35 (7.59; 9.19) 4.31 (3.71; 5.02)
A/Texas/50/2012 (H3N2) 10.1 (9.12; 11.1) 6.01 (5.03; 7.18)
B/Massachusetts/02/2012 (Yamagata 
lineage) 3.59 (3.35; 3.85) 2.16 (1.94; 2.40) 

B/Brisbane/60/2008 (Victoria lineage) 5.89 (5.43; 6.40) 3.18 (2.81; 3.59)
N=number of subjects with available data for the considered endpoint  
GMT: Geometric Mean Titer; CI: Confidence Interval; SCR: Seroconversion rate; GMTR: Geometric Mean Titer of 
individuals ratios (post dose / pre dose) 



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These immunogenicity data provide supportive information for the 18-49 years of age group in 
addition to vaccine efficacy data available in adults ≥ 50 years of age (see Clinical Efficacy). 
 
Clinical efficacy  

Supemtek efficacy in terms of prevention of laboratory-confirmed influenza-like illness (ILI) 
caused by any strain of influenza, was evaluated in adults ≥ 50 years of age and conducted during 
the 2014-2015 influenza season in the United States (study 2). 

A total of 8963 healthy, medically stable adults were randomized in a 1:1 ratio to receive a single 
dose of Supemtek (n=4474) or an egg-based quadrivalent inactivated influenza vaccine (n=4489). 
A total of 5412 (60.4%) subjects were 50-64 years of age, 2532 (28.2%) were 65-74 years of age 
and 1019 (11.4 %) were ≥ 75 years of age. 

The primary efficacy endpoint of Study 2 was reverse transcriptase polymerase chain reaction 
(rtPCR)-positive, protocol-defined ILI due to any strain of influenza. 

Laboratory-confirmed protocol defined ILI was defined as having at least one symptom in each of 
two categories of respiratory and systemic symptoms, which could include sore throat, cough, 
sputum production, wheezing and difficulty breathing, or systemic symptoms such as fever > 99°F 
(>37°C) , chills, fatigue, headache and myalgia, laboratory-confirmed by rtPCR. 
US epidemiological data for the 2014-2015 influenza season indicated that Influenza A (H3N2) 
viruses predominated and that most influenza A/H3N2 viruses were antigenically dissimilar while 
A/H1N1 and B viruses were antigenically similar to vaccine antigens. Supemtek met the pre-
specified success criterion for non-inferiority to the comparator pre-defined as a lower bound of the 
two sided 95% CI >-20%.  

Of the 4474 participants exposed to Supemtek in a phase 3 active-controlled study (Study 2), a total 
of 1761 were 65 years or older. Although no differences in safety or efficacy were observed 
between older and younger participants, the number of patients aged 65 and over in this study was 
not sufficient to determine statistically whether this age group will respond differently from younger 
individuals. 
 
Table 5: Relative Vaccine Efficacy (rVE) of Supemtek versus Comparator against 
Laboratory-Confirmed Influenza, Regardless of Antigenic Similarity to Vaccine Antigens, 
Adults 50 Years of Age and Older, Study 2 (Efficacy Population)1,2 

 Supemtek 
(N=4303) 

Comparator 
(N=4301) RR rVE % (95% CI) 

n Attack Rate % (n/N) n 
Attack Rate 
% (n/N) 

All rtPCR-positive 
Influenza3 96 2.2 138 3.2 0.70 30 (10

5, 47) 

All rtPCR-positive 
Influenza A3 73 1.7 114 2.7 0.64 36 (14, 53) 

All rtPCR-positive 
Influenza B3 23 0.5 24 0.6 0.96 4 (-72, 46) 

All Culture-confirmed 
Protocol-defined ILI3,4 58 1.3 101 2.3 0.57 43 (21, 59) 

Abbreviations: rtPCR=reverse transcriptase polymerase chain reaction; Comparator= an egg-based quadrivalent 
inactivated influenza vaccine; n=number of influenza cases; N=number of subjects in treatment group; RR=relative risk 
(Attack Rate Supemtek/Attack Rate IIV4); rVE = [(1-RR) x 100].  



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1 Excluded subjects with protocol deviations that could adversely affect efficacy. 
2 Primary Analysis. All cases of rtPCR-confirmed influenza are included. 
3 Post hoc analyses. All cases of influenza A were A/H3N2. Cases of influenza B were not distinguished by lineage.  
4 Culture of rtPCR-positive samples was performed in MDCK cells. 
5 The lower bound (LB) of the 95% confidence interval met the pre-specified, exploratory criterion for superior relative 
vaccine efficacy, LB > 9%. 
 
Efficacy of trivalent recombinant influenza vaccine (RIV3)  

The efficacy of trivalent recombinant influenza vaccine (RIV3) is relevant to Supemtek because 
both vaccines are manufactured using the same process and have overlapping compositions. 

The efficacy of trivalent recombinant influenza vaccine in protecting against influenza illness was 
evaluated in a randomized, observer-blind, placebo-controlled multicenter trial conducted in the 
United States during the 2007-2008 influenza season in adults 18-49 years of age (Study 3). 

Study 3 enrolled and vaccinated 4648 healthy adults randomized in a 1:1 ratio to receive a single 
dose of RIV3 (n=2344) or saline placebo (n=2304).  

The primary efficacy endpoint of Study 3 was defined as an influenza-like illness (ILI) with a 
positive culture for an influenza virus strain antigenically resembling a strain represented in RIV3. 
ILI is defined as fever of ≥100°F (37.8°C) oral accompanied by cough, sore throat, or both, on the 
same or consecutive days. Attack rates and vaccine efficacy (VE), defined as the reduction in the 
influenza rate for RIV3 relative to placebo, were calculated for the total vaccinated cohort (n=4648).  
Due to very small number of cultured confirmed influenza cases with matched strains, an 
exploratory analysis of VE of RIV3 against all strains, regardless of antigenic match, isolated from 
any subject with an ILI, not necessarily meeting ILI criteria was done, demonstrated an efficacy 
estimate of 44.8% (95% CI 24.4, 60.0). See Table 6 for VE by case definition. 
 
Table 6: Vaccine Efficacy Against Culture-Confirmed Influenza in Healthy Adults 18-
49 Years of Age, Study 31,3 

Case definition 
RIV3 (N=2344) Saline Placebo (N=2304) 

RIV3 
Vaccine 
Efficacy4 
% 

95% 
Confidence 
Interval Cases, 

n 
Rate, 
% 

Cases, 
n 

Rate, 
% 

Positive culture with a strain represented in the vaccine 
CDC-ILI2, all matched strains5 1 0.04 4 0.2 75.4 (-148.0, 99.5) 
Any ILI, all matched strains 2 0.1 6 0.3 67.2 (-83.2, 96.8) 
Positive culture with any strain, regardless of match to the vaccine 
CDC-ILI2, all strains 44 1.9 78 3.4 44.6 (18.8, 62.6) 
Sub-Type A 26 1.1 56 2.4 54.4 (26.1, 72.5) 
Type B 18 0.8 23 1.0 23.1 (-49.0, 60.9) 
Any ILI, all strains 64 2.7 114 4.9 44.8 (24.4, 60.0) 
Sub-Type A 41 1.7 79 3.4 49.0 (24.7, 65.9) 
Type B 23 1.0 36 1.6 37.2 (-8.9, 64.5) 

1 Vaccine efficacy (VE) = 1 minus the ratio of RIV3 /placebo infection rates (10). 
2 Centers for Disease Control and Prevention - defined influenza-like illness (CDC-ILI) defined as fever of ≥100ºF 
(37.8°C) oral accompanied by cough and/or sore throat, on the same day or on consecutive days. 
3 The pre-defined success criterion for the primary efficacy analysis was that the lower bound of the 95% confidence 
interval (CI) of VE should be at least 40%. 
4 Determined under the assumption of Poisson event rates, according to Breslow and Day, 1987. 



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5 Primary endpoint of trial.  
 

Paediatric population 

The European Medicines Agency has waived the obligation to submit the results of studies with 
Supemtek in children from 6 months to 3 years of age for the prevention of influenza infection.  
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Supemtek in children from 3 years to 17 years of age for the prevention of influenza infection (see 
section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3 Preclinical safety data 
 
Non-clinical safety data on the trivalent formulation revealed no special hazard for humans based on 
conventional studies of repeat dose and local toxicity, reproductive and developmental (including 
teratogenicity) toxicity and safety pharmacology studies.The results of these studies with trivalent 
recombinant influenza vaccine are relevant to Supemtek because both vaccines are manufactured 
using the same process and have overlapping compositions. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Polysorbate 20 (E432) 
Sodium chloride 
Sodium phosphate monobasic, monohydrate 
Sodium phosphate dibasic, dodecahydrate 
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other 
medicinal products. 
 
6.3 Shelf life 
 
 1 year. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze.  
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
6.5 Nature and contents of container 
 
0.5 mL solution in a pre-filled syringe (Type I borosilicate glass) with plunger stopper (grey butyl 
rubber), with separate needle or without needle. 



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Pack size:  
10 pre-filled syringes, with separate needle or without needle. 
5 pre-filled syringes, with separate needle or without needle. 
1 pre-filled syringe, with separate needle or without needle. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling  
 
The vaccine should be inspected visually for particulate matter and/or discoloration prior to 
administration. If either of these conditions exists, the vaccine should be discarded. 

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Sanofi Pasteur 
14 Espace Henry Vallée 
69007 Lyon 
France 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1484/001 
EU/1/20/1484/002 
EU/1/20/1484/003 
EU/1/20/1484/004 
EU/1/20/1484/005 
EU/1/20/1484/006 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: {DD month YYYY} 
 
 
10. DATE OF REVISION OF THE TEXT 
 

Detailed information on this medicinal product is available on the website of the European 
Medicines Agency http://www.ema.europa.eu 

  



12 
 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S) 
RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING 
SUPPLY AND USE 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



13 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturer(s) of the biological active substance(s) 

Unigen Inc. 
11 Azakamikasugo Miyaji Ikeda-cho  
Ibi-gun Gifu, Japan 

 

Name and address of the manufacturer(s) responsible for batch release 

Sanofi Pasteur 
Parc Industriel d'Incarville 
27100 Val de Reuil 
France 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to medical prescription. 
 

 Official batch release 
 

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be 
undertaken by a state laboratory or a laboratory designated for that purpose. 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  

 Periodic safety update reports (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 

The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 
months following authorisation. 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 
 Risk management plan (RMP) 
 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 



14 
 

marketing authorisation and any agreed subsequent updates of the RMP. 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile 
or as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

  



15 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



16 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



17 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer box, without needle or with separate needle – pack of 1, 5 and 10 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Supemtek solution for injection in pre-filled syringe 
Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture) 
xxxx/xxxx season 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Influenza virus haemagglutinin proteins of the following strains: 
A/xxxxxx (H1N1) - like virus  
A/xxxxxx (H3N2) - like virus  
B/xxxxxx - like virus 
B/xxxxxx - like virus  
 
45 microgram haemagglutinin per strain per 0.5 mL dose. 
 
 
 

3. LIST OF EXCIPIENTS 
 
Polysorbate 20 (E432), sodium chloride, sodium phosphate monobasic monohydrate, sodium 
phosphate dibasic dodecahydrate, water for injections. 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection in pre-filled syringe 
1 pre-filled syringe (0.5 mL) without needle 
10 pre-filled syringes (0.5 mL) without needle 
5 pre-filled syringes (0.5 mL) without needle 
 
1 pre-filled syringe (0.5 mL) with separate needle 
10 pre-filled syringes (0.5 mL) with separate needle 
5 pre-filled syringes (0.5 mL) with separate needle 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION
 
Intramuscular use (IM). 
Read the package leaflet before use. 
 



18 
 

 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

 
Keep out of the sight and reach of children. 
 
 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Keep the syringe in the outer carton in order to protect from light. 
 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sanofi Pasteur 
14 Espace Henry Vallée 
69007 Lyon 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1484/001 1 pre-filled syringe without needle 
EU/1/20/1484/002 1 pre-filled syringe with separate needle 
EU/1/20/1484/003 5 pre-filled syringes without needle 
EU/1/20/1484/004 5 pre-filled syringes with separate needle 
EU/1/20/1484/005 10 pre-filled syringes without needle 
EU/1/20/1484/006 10 pre-filled syringes with separate needle 
 
 

13. BATCH NUMBER 
 
Lot 



19 
 

 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 

15. INSTRUCTIONS ON USE 
 
 
 

16. INFORMATION IN BRAILLE 
 
Justification for not including braille accepted 
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
<PC: {number} 
SN: {number}>  
 



20 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 
UNITS 
 
Pre-filled syringe  

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Supemtek  
Injection 
Quadrivalent Influenza Vaccine  
xxxx/xxxx season 
 
 

2. METHOD OF ADMINISTRATION 
 
IM 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
 
1 dose – 0.5 mL 
 
 

6. OTHER 
 
 

  



21 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



22 
 

Package Leaflet – Information for the User 

Supemtek 

Solution for injection 

 Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture) 
 

▼This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side affects you may get. See the end of section 4 
for how to report side effects. 

Read all of this leaflet carefully before you receive this medicine because it contains 
important information for you. 

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, nurse or pharmacist. 
- This vaccine has been prescribed for you only. Do not pass it on to others. 
- If  you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 

What is in this leaflet:  

1. What Supemtek is and what it is used for  
2. What you need to know before you receive Supemtek 
3. How Supemtek is given 
4. Possible side effects 
5. How to store Supemtek 
6. Contents of the pack and other information 
 
 
1. What Supemtek is and what it is used for  

 
Supemtek is a vaccine for adults who are 18 years of age and older. This vaccine helps to protect 
you against flu (influenza). Supemtek is egg-free because of the technology used to produce it. 
 
How Supemtek works 
When a person is given Supemtek, the body’s natural defence (the immune system) produces 
protection against the influenza virus. None of the ingredients in the vaccine can cause flu. 
As with all vaccines, Supemtek may not fully protect all persons who are vaccinated. 
 
When to have a flu vaccine 
Flu can spread very fast.  
• It is caused by different types of flu virus that can change every year. This is why you might 

need to be vaccinated every year.  
• The greatest risk of catching flu is during the cold months between October and March.  
• If you were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring 

since you run the risk of catching flu until then.  
Your doctor will be able to recommend the best time to be vaccinated. 

 
 
2. What you need to know before you receive Supemtek 



23 
 

 
Do not use Supemtek if you are allergic to :  

• the active ingredients or any of the other ingredients of this medicine (listed in section 6).  
• octylphenol ethoxylate (octoxinol-9), a trace residual from the manufacturing process.  

 
Warnings and precautions  

Talk to your doctor, pharmacist or nurse before receiving Supemtek. 

As with all vaccines, Supemtek may not fully protect all persons who are vaccinated. 

Before receiving the vaccine, tell your doctor, nurse or pharmacist if: 
• you have a short-term illness with fever. Vaccination may need to be delayed until your 

fever has gone. 
• you have a weakened immune system (immunodeficiency or you are taking medicines that 

affect the immune system such as cancer medicine (chemotherapy) or corticosteroid 
medicines). 

• you have a bleeding problem or bruise easily. 
• you have fainted with an injection before. Fainting can happen after, or even before an 

injection. 
If any of the above apply to you (or you are not sure) talk to your doctor, pharmacist or nurse before 
receiving Supemtek.  
 
Other medicines and Supemtek 

Tell your doctor or nurse if you are using, have recently used or might use any other medicines, 
including medicines obtained without a prescription or if you have recently received any other 
vaccine.  
Supemtek may be given at the same time as other vaccines by using separate limbs. 
 
Pregnancy and breast-feeding  

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before using this vaccine. Your doctor or pharmacist will help 
you to decide if you should receive Supemtek. 
 
Driving and using machines 

Supemtek has no or negligible effect on your ability to drive and use machine. 
 
Supemtek contains sodium   

This vaccine contains less than 1 mmol sodium (23 mg) per dose, this means that it’s essentially 
‘sodium free’.  
 
 
3. How Supemtek is given 

 
Supemtek is given to you by your doctor, nurse or pharmacist as an injection into the muscle at the 
top of the upper arm (deltoid muscle). 

Adults from 18 years of age and older: 

One dose of 0.5 mL. 
 
 
4. Possible side effects  



24 
 

 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Severe allergic reactions 
Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency 
room right away if you have an allergic reaction. It can be life-threatening. 
Symptoms include: 
• difficulty breathing, shortness of breath  
• swelling of the face, lips, throat or tongue  
• cold, clammy skin  
• palpitations 
• feeling dizzy, feeling weak, fainting 
• rash or itching 

 
The following side effects have been reported with Supemtek: 
 
Other side effects 
Very common (may affect more than 1 in 10 people): 
• pain at the injection site 
• feeling tired (fatigue)  
• headache  
• muscle pain and joint pain  
Muscle pain and joint pain are common in adults aged 50 years and older. 
 
Common (may affect up to 1 in 10 people):  
• feeling sick (nausea) 
• redness, swelling, hardening around the area where the vaccine is injected 
• fever, shivering  
Fever is rare in adults aged 50 years and older. 
 
Uncommon (may affect up to 1 in 100 people): 
• diarrhoea 
• itching, skin irritation, rash 
• flu-like symptoms 
• cough, mouth and throat pain 
• itching where the vaccine is injected 
Itching is rare in adults aged 50 years and older. 
Skin irritation and rash have not been reported in adults aged 50 years and older. 
Flu-like symptoms has not been reported in adults aged 18-49 years. 
 
Rare (may affect up to 1 in 1000 people): 
• feeling dizzy 
• hives  
Feeling dizzy and hives have not been reported in adults aged 18-49 years. 
 
Not known (cannot be estimated from the available data): 
•   neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the 
limbs, loss of balance, loss of reflexes, paralysis of part or all the body (Guillain-Barré syndrome). 
 
Reporting of side effects 



25 
 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on 
the safety of this medicine. 
 
 
5.  How to store Supemtek 
 
Keep this vaccine out of the sight and reach of children. 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. 

 
Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information  

 
What Supemtek contains 

One dose (0.5 mL) contains: 
The active substances are influenza virus haemagglutinin (HA) proteins, of the following strains*: 
A/xxxxxx (H1N1) -like virus ......................................... 45 micrograms HA 
A/xxxxxx (H3N2) -like virus .........................................  45 micrograms HA 
B/xxxxxx- like virus....................................................... 45 micrograms HA 
B/xxxxxx - like virus...................................................... 45 micrograms HA 

  
* produced by recombinant DNA technology using a baculovirus expression system in a continuous 
insect cell line that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda. 
 
This vaccine complies with the World Health Organisation (WHO) recommendation (northern 
hemisphere) and EU recommendation for the {year/year} season.  

The other ingredients are: polysorbate 20 (E432), sodium chloride, sodium phosphate monobasic 
monohydrate, sodium phosphate dibasic dodecahydrate, water for injections. 
 
What Supemtek looks like and contents of the pack 

Supemtek is a solution for injection in a pre-filled syringe (ready to use syringe).  
Supemtek is a clear and colourless solution. 
A single syringe contains 0.5 mL of solution for injection.  
 
Supemtek is available in packs containing 1, 5 or 10 pre-filled syringes without needle or with 
separate needle. 
Not all pack sizes may be marketed. 
 
 
Marketing Authorisation Holder 

Sanofi Pasteur 
14 Espace Henry Vallée 



26 
 

69007 Lyon 
France 
 
Manufacturer 

Sanofi Pasteur 
Parc Industriel d'Incarville 
27100 Val de Reuil 
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 



27 
 

België/ Belgique /Belgien 
Sanofi Belgium 
Tél/Tel.: +32 02 710.54.00 

Lietuva 
Sanofi – Aventis Lietuva, UAB 
Tel.: +370 5 2755224

България 
SANOFI BULGARIA EOOD  
Teл.: +359 (0) 2 970 53 00 

Luxembourg/Luxemburg 
Sanofi Belgium 
tel.: +32 2 710.54.00

Česká republika 
Sanofi Pasteur 
divize. vakcín sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 

Magyarország 
sanofi-aventis zrt 
Tel.: +36 1 505 0055 

Danmark 
Sanofi A/S 
Tel: +45 4516 7000

Malta 
Sanofi S.r.l. 
Tel: +39 02 39394983

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel.: 0800 54 54 010 
Tel. aus dem Ausland: +49 69 305 21 130

Nederland 
Genzyme Europe B.V. 
Tel: +31 20 245 4000 

Eesti 
Sanofi-Aventis Estonia OÜ 
Tel.: +372 627 3488

Norge 
Sanofi-aventis Norge AS 
Tel: + 47 67 10 71 00

Ελλάδα 
ΒΙΑΝΕΞ Α.Ε.  
Τηλ: +30.210.8009111 

Österreich 
Sanofi-Aventis GmbH 
Tel: +43 (1) 80185-0.

España 
sanofi-aventis, S.A.  
Tel: +34 93 485 94 00 

Polska 
Sanofi Pasteur Sp. z o.o. 
Tel.: +48 22 280 05 00

France 
Sanofi Pasteur Europe 
Tél: 0800 42 43 46 
Appel depuis l’étranger : +33 1 57 63 67 97 

Portugal 
Sanofi – Produtos Farmacêuticos, Lda. 
Tel: + 351 21 35 89 400 

Hrvatska 
sanofi-aventis Croatia d.o.o 
Tel.: +385 1 6003 400 

România 
Sanofi Romania SRL 
Tel.: +40(21) 317 31 36

Ireland 
sanofi-aventis Ireland T/A SANOFI 
Tel: + 353 (0) 1 4035 600 

Slovenija 
sanofi-aventis d.o.o. 
Tel.: +386 1 560 48 00

Ísland 
Vistor 
Tel : +354 535 7000 

Slovenská republika 
sanofi-aventis Slovakia s.r.o. 
divízia vakcín Sanofi Pasteur 
Tel.: +421 2 33 100 100

Italia 
Sanofi S.r.l. 
Tel: 800536389  
Tel dall'estero: +39 02 39394983 

Suomi/Finland 
Sanofi Oy 
Tel: +358 (0) 201 200 300 

Κύπρος 
Γ. Α. Σταμάτης & Σια Λτδ. 
Τηλ.: +357 – 22 76 62 76 

Sverige 
Sanofi AB 
Tel: +46 8-634 50 00

Latvija 
Sanofi Aventis Latvia SIA Vakcīnu nodaļa 
Tel.: +371 67114978 

United Kingdom 
Sanofi 
Tel: +44 800 035 2525

 
 



28 
 

This leaflet was last revised in {XX/YYYY}.  

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

The following information is intended for healthcare professionals only:  

Appropriate medical treatment and supervision should always be readily available in case of a rare 
anaphylactic event following the administration of the vaccine.  

The vaccine should be visually inspected for particulate matter and discoloration prior to 
administration. In the event of any foreign particulate matter and/or variation of physical aspect 
being observed, do not administer the vaccine. 


	ANNEX ISUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) ANDMANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET