Dectova

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 

 

Dectova 10 mg/mL solution for infusion 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each mL of solution contains 10 mg of zanamivir (as hydrate). 

 

Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL. 

 

Excipients with known effect 

 

Each vial contains 3.08 mmol (70.8 mg) sodium. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Solution for infusion 

A clear, colourless solution for infusion. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus 

infection in adult and paediatric patients (aged ≥6 months) when: 

 

• The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal 
products other than zanamivir, and/or 

 

• Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not 
suitable for the individual patient. 

 

Dectova should be used in accordance with official guidance. 

 

4.2 Posology and method of administration 

 

Posology 

 

Treatment with Dectova should commence as soon as possible and usually within 6 days of the onset of 

symptoms of influenza (see section 5.1). 

 

Adults 

The recommended dose is 600 mg twice daily for 5 to 10 days given by intravenous infusion. 

 

Paediatric population 



3 

 

Adolescents, children and infants should receive a weight-based dose regimen for 5 to 10 days (Table 1). 

 

Table 1: Weight-based dose regimen by age for infants, children and adolescents with normal renal 

function 

 

Age range Weight-based dose regimen 

6 months to < 6 years 14 mg/kg twice daily 

 6 years to < 18 years  12 mg/kg twice daily up to a maximum dose of 600 mg 

twice daily 

 

The safety and efficacy of Dectova in children aged under 6 months have not been established. No data are 

available. 

 

Elderly 

No dose adjustment is required based on age. 

 

Renal impairment 

Adults and children (aged 6 years and over with a body weight of 50 kg or above) with creatinine clearance 

(CLcr) or clearance by continual renal replacement therapy (CLCRRT) < 80 mL/min should receive an initial 

600 mg dose followed by twice-daily maintenance dosing according to their renal function (Table 2). 

 

Table 2: Initial and maintenance dose regimens for adults and children (6 years and over with a body 

weight of 50 kg or above) with renal impairment 

 

CLcr or CLCRRT  
(mL/min or 

mL/min/1.73m2)* 

Initial Dose Maintenance Dose Maintenance Dose Schedule 

50 to <80 600 mg 400 mg twice daily 
Begin maintenance dosing 12 

hours after the initial dose 
30 to <50 600 mg 250 mg twice daily 

15 to <30 600 mg 150 mg twice daily 
Begin maintenance dosing 24 

hours after the initial dose 

< 15 600 mg 60 mg twice daily 
Begin maintenance dosing 48 

hours after the initial dose 

*CLcr or CLCRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m2 for 

children 6 years to less than 13 years. 

 

Children and adolescents (6 years to less than 18 years with a body weight less than 50 kg), and infants and 

children (6 months to less than 6 years) with creatinine clearance (CLcr) or clearance by continual renal 

replacement therapy (CLCRRT) <80 mL/min should receive an initial dose followed by an appropriate 

twice-daily maintenance dose as shown in Tables 3, 4 and 5. 

 



4 

 

Table 3: Initial and maintenance dose regimens for children and adolescents (6 years to less than 18 

years, with a body weight less than 50 kg) with renal impairment 

 

CLcr or CLCRRT)  
(mL/min or 

mL/min/1.73m2)* 

Initial dose Maintenance Dose Maintenance Dose Schedule 

50 to <80 12 mg/kg 8 mg/kg twice daily 
Begin twice daily maintenance 

dosing 12 hours after the initial 

dose 
30 to <50 12 mg/kg 5 mg/kg twice daily 

15 to <30 12 mg/kg 3 mg/kg twice daily 

Begin twice daily maintenance 

dosing 24 hours after the initial 

dose 

< 15 12 mg/kg 
1.2 mg/kg twice 

daily 

Begin twice daily maintenance 

dosing 48 hours after the initial 

dose 

*CLcr or CLCRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m2 for 

children 6 years to less than 13 years. 

 

Table 4: Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, 

with a body weight of 42.8 kg or above) with renal impairment 

 

CLcr or CLCRRT 

(mL/min/1.73 m2) 
Initial dose Maintenance Dose Maintenance Dose Schedule 

50 to <80 600 mg 400 mg twice daily 
Begin twice daily maintenance 

dosing 12 hours after the initial 

dose 
30 to <50 600 mg 250 mg twice daily 

15 to <30 600 mg 150 mg twice daily 

Begin twice daily maintenance 

dosing 24 hours after the initial 

dose 

< 15 600 mg 60 mg twice daily 

Begin twice daily maintenance 

dosing 48 hours after the initial 

dose 

 

Table 5: Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, 

with a body weight less than 42.8 kg) with renal impairment 

 

CLcr or CLCRRT 
(mL/min/1.73 m2) 

Initial dose Maintenance Dose Maintenance Dose Schedule 

50 to <80 14 mg/kg 
9.3 mg/kg twice 

daily 

Begin twice daily maintenance 

dosing 12 hours after the initial 

dose 
30 to <50 14 mg/kg 

5.8 mg/kg twice 

daily 

15 to <30 14 mg/kg 
3.5 mg/kg twice 

daily 

Begin twice daily maintenance 

dosing 24 hours after the initial 

dose 

< 15 14 mg/kg 
1.4 mg/kg twice 

daily 

Begin twice daily maintenance 

dosing 48 hours after the initial 

dose 

 

For patients on intermittent haemodialysis or intermittent peritoneal dialysis, the dose should be given after 

completion of the dialysis session. 

 



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For patients receiving continuous renal replacement therapy, the dose should be selected using the 

appropriate CRRT clearance (CLCRRT in mL/min). 

 

Hepatic impairment 

No dose modification is required (see section 5.2). 

 

Method of administration 

 

Intravenous use 

 

Dectova is administered by intravenous infusion over 30 minutes. 

 

For instructions on dilution of the medicinal product before administration, see section 6.6. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

4.4 Special warnings and precautions for use 

 

Renal impairment 

 

Zanamivir is eliminated by renal clearance, therefore the dose of Dectova when administered intravenously 

must be reduced in patients with renal impairment (see section 4.2). All patients must have their renal 

function assessed before and regularly during treatment. 

 

Serious hypersensitivity reactions 

 

Anaphylactic reactions and serious skin reactions (including erythema multiforme, toxic epidermal 

necrolysis and Stevens-Johnson syndrome) have been reported with zanamivir (see section 4.8). If any 

hypersensitivity reaction occurs during infusion of Dectova, the infusion must be stopped immediately and 

appropriate management should be instituted. 

 

Neuropsychiatric events 

 

Influenza can be associated with a variety of neurological and behavioural symptoms. Neuropsychiatric 

events, including seizures, delirium, hallucination and abnormal behaviour, have been reported during 

administration of zanamivir in patients with influenza, especially in children and adolescents. Therefore, 

patients should be closely monitored for behavioural changes and the benefits and risks of continuing 

treatment should be carefully evaluated for each patient (see section 4.8). 

 

Resistance in immunocompromised patients 

 

Treatment emergent resistance is rare with zanamivir (see section 5.1). Selection of influenza resistant 

viruses is more likely to occur following treatment with antiviral medicinal products in immunocompromised 

patients, including treatment with Dectova; it is, therefore, important to monitor for resistance and consider 

switching to alternative therapies where appropriate. 

 

Limitations of the clinical data 

 

The efficacy of Dectova for the treatment of complicated influenza A or B virus infection in adults and 

children aged from 6 months has been inferred from: 

 

• the in vitro activity of zanamivir; 



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• clinical and virological activity of zanamivir compared to placebo in a human influenza challenge 

study; 

• levels of zanamivir in broncho-epithelial lining fluid and serum zanamivir from a broncho-alveolar 

lavage study; 

• serum zanamivir levels from patients with complicated influenza (see section 5.1). 

 

Risk of bacterial infections 

 

Dectova has not been shown to reduce the risk of bacterial complications associated with influenza infection. 

 

Excipients 

 

This medicinal product contains 70.8 mg sodium per vial, equivalent to 3.54% of the WHO recommended 

maximum daily intake of 2 g sodium for an adult. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

The potential for interactions with other medicines is low, based on the known elimination pathway of 

zanamivir. 

 

Zanamivir is not a substrate, inhibitor or inducer of cytochrome P450 isoenzymes nor a substrate or inhibitor 

of renal and hepatic transporters at clinically relevant concentrations (see section 5.2). 

 

There was no evidence of interaction with oral oseltamivir in a clinical study. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

There are limited data from the use of zanamivir in pregnant women. Animal studies do not indicate direct or 

indirect harmful effects with respect to reproductive toxicity (see section 5.3). 

 

Reproductive studies performed in rats and rabbits indicated that placental transfer of zanamivir occurs and 

there was no evidence of teratogenicity. Results from a rat peri- and postnatal study showed no clinically 

meaningful impairment of offspring development. However, there is no information on placental transfer in 

humans. 

 

As experience is limited, the use of Dectova in pregnancy should only be considered if the possible benefit to 

the patient is thought to outweigh any possible risk to the foetus. 

 

Breast-feeding 

 

It is unknown whether zanamivir is excreted in human milk. In rats, zanamivir has been shown to be secreted 

in low amounts into milk. 

 

As experience is limited, the use of zanamivir in breast-feeding mothers should be considered only if the 

possible benefit to the mother is thought to outweigh any possible risk to the child. 

 

Fertility 

 

Animal studies indicate no clinically meaningful effects of zanamivir on male or female fertility. 

 

4.7 Effects on ability to drive and use machines 

 

Dectova has no or negligible influence on the ability to drive and use machines. 



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4.8 Undesirable effects 

 

Summary of the safety profile 

 

The safety profile of Dectova is based primarily on data from a single Phase II and a single Phase III study, 

with support from Phase I studies, a compassionate use programme, and adverse drug reactions reported for 

inhaled zanamivir. The frequency of adverse reactions is based on the number of reports in the adult 

population receiving zanamivir 600 mg twice daily intravenously in the Phase II and Phase III studies. 

Adverse reactions are listed by MedDRA system organ class. 

 

The most commonly reported adverse reactions considered possibly or probably related to Dectova are 

alanine aminotransferase increased (2%), aspartate aminotransferase increased (1%), hepatocellular injury 

(1%), diarrhoea (1%) and rash (1%). The most important serious adverse reaction was hepatocellular injury, 

observed in two patients (<1%). 

 

Tabulated list of adverse reactions 

 

The frequency of adverse reactions is defined using the following convention: very common (≥1/10); 

common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 

(<1/10,000) and not known (cannot be estimated from available data). 

 

System Organ Class Adverse reactions Frequency 

Immune system disorders oropharyngeal oedema 

facial oedema 

anaphylactic/anaphylactoid reactions 

 

not known 

Psychiatric disorders abnormal behaviour 

hallucinations 

delirium 

 

not known 

Nervous system disorders convulsions 

depressed level of consciousness 

 

not known 

Gastrointestinal disorders diarrhoea 

 

common 

Hepatobiliary disorders alanine aminotransferase (ALT) and/or aspartate 

aminotransferase (AST) increased 

hepatocellular injury 

 

common 

alkaline phosphatase increased 

 

uncommon 

Skin and subcutaneous tissue 

disorders 

rash 

 

common 

urticaria 

 

uncommon 

erythema multiforme 

Stevens-Johnson syndrome 

toxic epidermal necrolysis 

 

not known 

 

Paediatric population 

 

The adverse reaction profile in the paediatric population is based on 71 patients aged ≥6 months to <18 years 

in the Phase II study. Overall, the safety profile in paediatric patients was similar to that observed in adults in 

the clinical studies. 



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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 

 

There is limited experience of overdose from administration of Dectova. There is no specific antidote to treat 

an overdose of this medicine. Treatment of an overdose should consist of general supportive measures 

including monitoring of vital signs and observation of the clinical status of the patient. Zanamivir is cleared 

by renal excretion and is expected to be removed by haemodialysis. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors 

ATC code: J05AH01 

 

Mechanism of action 

 

Zanamivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the 

plasma membrane of infected cells and promotes virus spread in the respiratory tract.  

 

In vitro activity 

 

Neuraminidase inhibition occurred at very low zanamivir concentrations in vitro, with median inhibitory 

(IC50) values of 0.33 nM to 5.77 nM against influenza A and B strains respectively. 

 

Resistance 

Resistance selection during zanamivir treatment is rare. Reduced susceptibility to zanamivir is associated 

with mutations that result in amino acid changes in the viral neuraminidase or viral hemagglutinin or both. 

Neuraminidase substitutions conferring reduced susceptibility to zanamivir have emerged during treatment 

with zanamivir in human viruses and those with zoonotic potential: E119D, E119G, I223R, R368G, G370D, 

N434S (A/H1N1); N294S, T325I (A/H3N2); R150K (B); R292K (A/H7N9). The neuraminidase substitution 

Q136K (A/H1N1 and A/H3N2), confers high level resistance to zanamivir but is selected during adaptation 

to cell culture and not during treatment. 

 

The clinical impact of reduced susceptibility in these viruses is unknown, and the effects of specific 

substitutions on virus susceptibility to zanamivir may be strain-dependent. 

 

Cross-resistance 

Cross-resistance between zanamivir and oseltamivir or peramivir has been observed in neuraminidase 

inhibition assays. A number of neuraminidase amino acid substitutions that arise during oseltamivir or 

peramivir treatment result in reduced susceptibility to zanamivir. The clinical impact of substitutions 

associated with reduced susceptibility to zanamivir and other neuraminidase inhibitors is variable and may 

be strain-dependent. 

 

The H275Y substitution is the most common neuraminidase resistance substitution and is associated with 

reduced susceptibility to peramivir and oseltamivir. This substitution has no effect on zanamivir; therefore, 

viruses with the H275Y substitution retain full susceptibility to zanamivir. 

 



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Clinical efficacy 

 

Human challenge study 

A double-blind, randomised study to examine the prophylactic antiviral activity and efficacy of repeat dose 

zanamivir 600 mg every 12 hours intravenously compared to placebo in healthy male volunteers against 

infection from inoculation with influenza A/Texas/91 (H1N1) virus was conducted. Zanamivir had a 

significant prophylactic effect against an experimental challenge with influenza A virus as demonstrated by 

the low infection rate (14% vs. 100% positive serology in placebo group, p <0.005), isolation of virus by 

viral culture (0% vs. 100% in placebo group, p <0.005), as well as reductions in fever (14% vs. 88% in 

placebo group, p <0.05), upper respiratory tract illness (0% versus 100% in placebo group, p<0.005) and 

total symptom scores (1 vs. 44 median score in placebo group, p<0.001). 

 

Bronchoalveolar lavage study 

A Phase I, open-label study to evaluate serum and lower respiratory pharmacokinetics following 

administration of intravenous and inhaled zanamivir to healthy adult subjects utilising bronchoalveolar 

lavage fluid was conducted. The 600 mg dose given intravenously best approximated epithelial lining fluid 

concentrations achieved by the approved 10 mg dose of zanamivir inhalation powder which demonstrated 

efficacy in large clinical studies in uncomplicated influenza. 

 

Phase III study in patients with complicated influenza 

A Phase III, double-blind, study was conducted to evaluate the efficacy, antiviral activity and safety of 

zanamivir 600 mg twice daily intravenously compared to oral oseltamivir 75 mg twice daily and 300 mg 

zanamivir twice daily intravenously in hospitalised patients (>16 years of age) with influenza. The median 

patient age was 57 years and 35% (218/615) of patients were ≥65 years, of which 17% (n=103) were 65 to 

<75; 14% (n=84) were 75 to <85, and 5% (n=31) were ≥85 years of age. Patients were stratified at 

randomisation based on time from onset of symptoms to initiation of treatment (≤4 days and 5 to 6 days). 

Eligible patients were not to have had >3 days of prior antiviral treatment. The initial 5 day treatment course 

could be extended for up to 5 additional days if clinical symptoms or patient characteristics warranted further 

treatment. The primary endpoint was time to clinical response (TTCR); clinical response was defined as a 

composite of vital sign stabilisation (temperature, oxygen saturation, respiratory status, heart rate and 

systolic blood pressure) or hospital discharge. The primary analysis was performed on the Influenza Positive 

Population (IPP) comprised of 488 patients. The study did not meet its pre-specified primary objective of 

demonstrating superiority of 600 mg zanamivir to oral oseltamivir or to 300 mg zanamivir in TTCR. There 

were no significant differences in TTCR across treatment comparisons in the overall IPP or in two pre-

specified subgroups (Table 6). 

 



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Table 6: Statistical comparisons of TTCR between the 600 mg zanamivir group and each other group 

(IPP) 

 

 Zanamivir 

solution for 

infusion  

300 mg 

Zanamivir 

solution for 

infusion 

600 mg 

Oseltamivir 

75 mg 

Influenza Positive Population, N 163 162 163 

Median TTCR, days 5.87 5.14 5.63 

Median difference between treatments, days (95% CI) -0.73 (-1.79, 0.75) -0.48 (-2.11, 0.97) 

p-value from Wilcoxon rank-sum 2-sided test 0.25 0.39 

Intensive Care Unit/Mechanical Ventilation subgroup, N 68 54 68 

Median TTCR, days 11.26 12.79 14.58 

Median difference between treatments, days (95% CI) 1.53 (-4.29, 8.34) -1.79 (-11.1, 6.92) 

p-value from Wilcoxon rank-sum 2-sided test 0.87 0.51 

Symptom onset 4 days subgroup, N 127 131 121 

Median TTCR, days 5.63 4.80 4.80 

Median difference between treatments, days (95% CI) -0.83 (-1.98, 0.56) 0.00 (-1.05, 0.97) 

p-value from Wilcoxon rank-sum 2-sided test 0.09 0.82 

 

This medicinal product has been authorised under ‘exceptional circumstances’. 

This means that for scientific reasons it has not been possible to obtain complete information on this 

medicinal product. 

The European Medicines Agency will review any new information which may become available every year 

and this SmPC will be updated as necessary. 

 

Paediatric population 

 

The European Medicines Agency has deferred the obligation to submit the results of studies with Dectova in 

one or more subsets of the paediatric population in the treatment and prevention of influenza (see section 4.2 

for information on paediatric use). 

 

5.2 Pharmacokinetic properties 

 

The serum pharmacokinetics of zanamivir administered intravenously have been studied in healthy 

volunteers receiving single escalating doses from 1 to 1200 mg and repeated doses of 600 mg twice daily for 

5 days. Hospitalised patients with influenza also have received 300 mg or 600 mg twice daily for 5 to 

10 days. 

 

Dose proportionality was observed in zanamivir Cmax and AUC and no accumulation of zanamivir in serum 

was evident after repeated intravenous doses of up to 600 mg. 

 

Distribution 

 

The plasma protein binding of zanamivir is very low (less than 10%). The volume of distribution of 

zanamivir in adults is approximately 16 litres, which approximates the volume of extracellular water. 

 

Following twice-daily administration of zanamivir solution for infusion, pulmonary epithelial lining fluid 

concentrations were 60 - 65 % of the serum concentrations at the corresponding sampling time 12 hours after 

dosing. Following twice daily administration of 600 mg zanamivir solution for infusion, median trough 

zanamivir epithelial lining fluid concentrations ranged from 419 ng/mL to 584 ng/mL and were 47-66% of 

those in the initial bronchoalveolar sample following orally zanamivir inhalation powder 10 mg twice daily. 

 

Biotransformation 

 



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There is no evidence that zanamivir is metabolised. 

 

Elimination 

 

Zanamivir is eliminated unchanged in urine by glomerular filtration. In adults with normal renal function, the 

elimination half-life is approximately 2-3 hours. 

 

Elderly 

 

The pharmacokinetics in elderly subjects was similar to young adult subjects. In the population 

pharmacokinetic analysis, age had no significant effect on the pharmacokinetics of zanamivir. 

 

Paediatric population  

 

The pharmacokinetics of zanamivir following a twice daily intravenous dose of 14 mg/kg for paediatric 

patients between 6 months and <6 years and 12 mg/kg for those between 6 years and <18 years of age were 

similar to those seen in adults who received 600 mg twice daily intravenously. The pharmacokinetics of 

zanamivir in subjects 6 months to <18 years of age (administered standard dose of 12 mg/kg, 14 mg/kg or 

600 mg according to age and body weight) and in adult subjects (administered standard dose of 600 mg) was 

similar (Table 7). 

 

Table 7: Pharmacokinetic parameters in paediatric and adult subjects 

Age 

Group 

Dose N Cmax  

(g/mL) 

AUC(0-)  

(g.h/mL) 

Cmin  

(g/mL) 

T1/2 

(h) 

GM %CV GM %CV GM Range GM %CV 

6 months 

- <1 year  

14 

mg/kg 

7 36.2 21 75.3 23 NA NA 1.84 19 

1 - <2 

years  

14 

mg/kg 

6 37.8 24 72.4 14 0.305  NA 2.49 118 

2 - <6 

years  

14 

mg/kg 

12 41.5 23 80.3 38 0.277  0.133 – 0.984 1.60 34 

6 - <13 

years 

12 

mg/kg 

16 44.2 47 107 41 0.564  0.111 – 2.31 2.57 55 

13 - <18 

years  

600 

mg 

13 34.5 27 91.1 27 0.211  0.104 – 0.428 2.06 47 

>18 

years 

600 

mg 

67 32.8 34 82.9 36 
0.82 0.1 - 11.4 2.39 31 

%CV = percent coefficient of variation, GM = Geometric Mean, NA = Not available 

 

Renal impairment 

 

The serum half-life of zanamivir increases to approximately 12-20 hours in patients with severe renal 

impairment (creatinine clearance < 30 mL/min). Dectova has not been studied in patients with end-stage 

renal disease. 

 

There are limited data on zanamivir exposure during concomitant continuous renal replacement therapy and 

very limited data with dialysis. 

 

Hepatic impairment 

 

Zanamivir is not metabolised, therefore no effect of hepatic impairment is expected. 

 

Race 

 



12 

 

Pharmacokinetic studies in Thai, Chinese and Japanese healthy subjects did not identify any clinically 

relevant differences in the pharmacokinetics of zanamivir in these populations compared with Caucasians. 

 

Drug interactions 

 

In vitro studies indicate that zanamivir is not an inhibitor or substrate of Breast Cancer Resistant Protein 

(BCRP), P-glycoprotein, Multidrug And Toxin Extrusion protein (MATE)1, MATE2-K, Organic Anion 

Transporter (OAT)1, OAT3, Organic Anion Transporting Polypeptide (OATP)1B1, OATP1B3 and Organic 

Cation Transporter (OCT)2 transporters, nor is it an inhibitor of cytochrome P450 (CYP) enzymes CYP1A2, 

2B6, 2C8, 2C9, 2C19, 2D6 and 3A4. 

 

Zanamivir is not an inducer of CYP1A2 and 2B6 and, although induction of CYP3A4 in vitro was observed 

at 50-fold higher than the clinically relevant concentrations, no interaction with CYP3A4 substrates is 

expected based on physiologically based pharmacokinetic modelling. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, 

repeated dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development, 

with the exception of a rat embryofoetal development study (subcutaneous administration). In the rat 

embryofoetal study, there was an increase in the incidence rates of a variety of minor skeletal and visceral 

alterations, most of which remained within the background rates of the historical occurrence in the strain 

studied. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Sodium chloride 

Water for injections 

 

6.2 Incompatibilities 

 

Dectova must not be mixed with other medicinal products except those mentioned in section 6.6. 

 

Dectova should not be administered simultaneously with other intravenous medicinal products or prepared in 

solutions containing glucose or other electrolytes (see section 6.6). 

 

6.3 Shelf life 

 

Unopened vials 

 

5 years. 

 

After dilution 

 

From a microbiological point of view, the product should be used immediately. If not used immediately, 

in-use storage times and conditions prior to use are the responsibility of the user and should not be longer 

than 24 hours at 2ºC to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions. 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

For storage conditions after dilution of the medicinal product, see section 6.3. 



13 

 

 

6.5 Nature and contents of container 

 

26 mL clear vial (type I glass) with a stopper (coated chlorobutyl rubber), an over-seal (aluminium) and a 

plastic flip-off cap. 

 

Pack size: 1 vial. 

 

6.6 Special precautions for disposal and other handling 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

Preparation of Dectova 

 

• The volume of Dectova and total volume for infusion will depend on the patient’s age, weight and 
renal function (see section 4.2). 

• The dose can be infused as supplied or diluted in sodium chloride 9 mg/mL (0.9%) solution for 
injection down to any concentration greater than or equal to 0.2 mg/mL. 

• Each vial is for single use only; once the seal has been broken, the remaining volume must be 
discarded. 

 

How to prepare the infusion for intravenous administration: 

 

• Use aseptic techniques throughout preparation of the dose. 

• Calculate the required dose and volume of Dectova. 

• Decide on the volume of sodium chloride 9 mg/mL (0.9%) solution for injection to be used for 
infusion. 

• Using a sterile needle and syringe, withdraw and discard a volume of sodium chloride 9 mg/mL 
(0.9%) solution for injection (equal to the volume of Dectova) from the infusion bag. 

• Infusion bags may have a further overage of sodium chloride 9 mg/mL (0.9%) solution for injection 
included – this can also be removed if considered necessary. 

• Using a sterile needle and syringe withdraw the volume of Dectova from the vial(s) and add to the 
infusion bag. 

• Discard any unused portion of the vial. 

• The infusion bag should be gently manipulated by hand to ensure it is mixed thoroughly. 

• If refrigerated, the infusion bag should be removed from the refrigerator and brought up to room 
temperature before use. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

GlaxoSmithKline Trading Services Limited 

12 Riverwalk 

Citywest Business Campus 

Dublin 24 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/18/1349/001 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 



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Date of first authorisation: 26 April 2019 

 

 

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 

 

 

http://www.ema.europa.eu/


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ANNEX II 

 

A. MANUFACTURER 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 

 

E. SPECIFIC OBLIGATION TO COMPLETE POST-

AUTHORISATION MEASURES FOR THE MARKETING 

AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 



16 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

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

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) 

Harmire Road 

Barnard Castle 

DURHAM 

DL12 8DT 

United Kingdom 

 

Or 

 

GlaxoSmithKline Manufacturing S.P.A 

Strada Provinciale Asolana No. 90 

43056 San Polo di Torrile, Parma 

Italy 

 

The printed package leaflet of the medicinal product must state the name and address of the manufacturer 

responsible for the release of the concerned batch. 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription. 

 

 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 

 

• Periodic safety update reports 
 

The requirements for submission of periodic safety update reports 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 shall submit the first periodic safety update report 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 MAH shall perform the required pharmacovigilance activities and interventions detailed in the  

agreed RMP presented in Module 1.8.2 of the 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. 

 

 

E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR 



17 

 

THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 

 

This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of 

Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following 

measures: 

 

 

 

 

Description Due date 

A retrospective observational chart review study to evaluate the clinical effectiveness of 

treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care 

unit-treated (ICU) patients with complicated influenza infection  

 

In order to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml 

solution for infusion in ICU-treated influenza patients, the MAH should submit the 

results of an observational chart review effectiveness study of IV zanamivir in 

ICU-treated influenza patients. 

 

Annual reports 

to be submitted 

 

 

Q3 2025 

 

A prospective observational study to evaluate the clinical effectiveness of treatment with 

zanamivir 10 mg/ml solution for infusion in patients with complicated influenza 

infection 

 

In order to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml 

solution for infusion in patients with complicated influenza infection, the MAH should 

submit the results of a prospective observational study in patients with complicated 

influenza infection. 

 

Annual reports 

to be submitted 

 

 

 

 



18 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET



19 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING



20 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON  

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Dectova 10 mg/mL solution for infusion 

zanamivir 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL (10 mg/mL). 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains sodium chloride, water for injections 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for infusion 

200 mg/20 mL 

1 vial 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Intravenous use 

Read the package leaflet before use. 

For single use only. 

 

 

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 

 

 



21 

 

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 

 

GlaxoSmithKline Trading Services Limited 

12 Riverwalk 

Citywest Business Campus 

Dublin 24 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1349/001 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

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: 

SN: 

NN: 

 

 



22 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

VIAL LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Dectova 10 mg/mL solution for infusion 

zanamivir 

IV 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

200 mg/20 mL 

 

 

6. OTHER 

 

 



23 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



24 

 

Package leaflet: Information for the patient 

 

Dectova 10 mg/mL solution for infusion 

zanamivir 

 

This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how to 

report side effects. 

 

Read all of this leaflet carefully before you are given 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 or nurse. 

- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 

listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What Dectova is and what it is used for 

2. What you need to know before you are given Dectova 

3. How Dectova is given 

4. Possible side effects 

5. How to store Dectova 

6.  Contents of the pack and other information 

 

 

1. What Dectova is and what it is used for 

 

Dectova contains zanamivir, which belongs to a group of medicines called antivirals. 

Dectova is used to treat severe flu (influenza virus infection). It is used when other flu treatments are not 

suitable. 

Adults and children aged 6 months or more can be treated with Dectova. 

 

 

2. What you need to know before you are given Dectova  

 

Do not use Dectova: 

• if you are allergic to zanamivir or any of the other ingredients of this medicine (listed in section 6). 
 

Warnings and precautions 

 

Serious skin or allergic reactions 

 

Serious skin or allergic reactions may occur after Dectova is given. Symptoms may include skin or throat 

swelling, difficulty breathing, blistering rash or peeling skin (see also ‘Serious skin or allergic reactions’ in 

section 4). 

 

Sudden changes in behaviour, hallucinations and fits 

 

During treatment with Dectova, changes in behaviour such as confusion and unresponsiveness may occur. 

Some people may also have hallucinations (seeing, hearing, or feeling things that are not there) or fits 

(seizures) which can lead to loss of consciousness. These symptoms also occur in people with flu who are 

not being given Dectova. So it is not known if Dectova played a part in causing them. 

 

If you notice any of the above symptoms: 



25 

 

➔ Tell a doctor or nurse immediately. 

 

Other medicines and Dectova 

Tell your doctor if you are taking, have recently taken or might take any other medicines. 

 

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 for advice before you are given this medicine. 

 

Driving and using machines 

Dectova should not affect your ability to drive or use machines. 

 

Dectova contains sodium 

This medicine contains 70.8 mg sodium (main component of cooking/table salt) in each vial. This is 

equivalent to 3.54% of the recommended maximum daily intake of sodium for an adult. 

 

 

3. How Dectova is given 

 

How much Dectova is given 

Your doctor will decide how much Dectova is right for you. The amount you are given is based on your age, 

body weight, and the results of your blood tests (to check how well your kidneys are working). 

 

Your dose may be increased or decreased depending on how well you respond to treatment. 

 

Adults 

The recommended dose is 600 mg twice daily for 5 to 10 days. 

 

If your kidneys are not working as well as they should, your doctor will decide on the reduced dose for you. 

 

Children  

Your doctor will decide on the correct dose of Dectova. 

 

When and how Dectova is given 

Dectova should be given as soon as possible, usually within 6 days of the symptoms of flu appearing. 

 

A doctor or nurse will give you Dectova as an infusion (drip) into a vein. It is usually given into your arm 

over about 30 minutes. 

 

If you have any questions on the use of Dectova, ask the doctor or nurse who is giving it you. 

 

If you are given more Dectova than you should 

It is unlikely that you will be given too much, but if you think you have been given too much Dectova, tell 

your doctor or nurse immediately. 

 

 

4. Possible side effects 

 

Like all medicines, Dectova can cause side effects, although not everybody gets them. 



26 

 

 

Serious skin and allergic reactions may occur with Dectova, but there isn’t enough information to 

estimate how likely they are. Contact your doctor or nurse straight away if you notice any of the following 

serious side effects: 

• very severe skin reactions such as: 
o a skin rash, which may blister, and looks like small targets (erythema multiforme) 
o a widespread rash with blisters and peeling skin, particularly occurring around the mouth, 

nose, eyes and genitals (Stevens-Johnson syndrome) 

o extensive peeling of the skin on much of the body surface (toxic epidermal necrolysis). 

• severe allergic reactions, including features such as itchy rash, swelling of the face, throat or tongue, 
breathing difficulty, light headedness and vomiting. 

 

Common side effects 

These may affect up to 1 in 10 people 

• diarrhoea 

• liver damage (hepatocellular injury) 

• rash. 

 

Common side effects that may show up in your blood tests: 

• increase in the level of liver enzymes (raised aminotransferases). 

 

Uncommon side effects 

These may affect up to 1 in 100 people 

• itchy, bumpy rash (hives). 

 

Uncommon side effects that may show up in your blood tests: 

• increase in the level of liver or bone enzymes (raised alkaline phosphatase). 

 

Side effects where it is not known how likely they are to happen 

There isn’t enough information to estimate how likely these side effects are: 

• acting strangely 

• seeing, hearing or feeling things which are not there 

• confused thinking 

• fits (seizures) 

• being less alert or not responding to loud sounds or being shaken 

 

Reporting of side effects  

If you get any side effects, talk to your doctor 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 Dectova 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. 

 

Vials of Dectova are for single use only. Any unused solution should be discarded. 

 

 

6. Contents of the pack and other information 

 

What Dectova contains 

The active substance is zanamivir. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


27 

 

Each mL of Dectova contains 10 mg of zanamivir (as hydrate). Each vial contains 200 mg of zanamivir (as 

hydrate). 

Other ingredients are sodium chloride and water for injections. 

 

What Dectova looks like and contents of the pack 

Dectova is a clear, colourless solution for infusion containing 200 mg zanamivir (as hydrate) in 20 mL. It is 

supplied in a 26 mL clear glass vial with a rubber stopper and an aluminium over-seal with a plastic flip off 

cap. 

 

There is 1 vial in each pack. 

 

Marketing Authorisation Holder 

GlaxoSmithKline Trading Services Limited 

12 Riverwalk 

Citywest Business Campus 

Dublin 24 

Ireland 

 

Manufacturer 

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) 

Harmire Road 

Barnard Castle 

County Durham 

DL12 8DT  

UK 

 

Or 

 

GlaxoSmithKline Manufacturing S.P.A 

Strada Provinciale Asolana, 90 

43056 San Polo di Torrile 

Parma 

Italy 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien  

GlaxoSmithKline Pharmaceuticals s.a./n.v. 

Tél/Tel: + 32 (0) 10 85 52 00 

 

Lietuva  

GlaxoSmithKline Lietuva UAB 

Tel: + 370 5 264 90 00 

info.lt@gsk.com 

 

България  

ГлаксоСмитКлайн ЕООД  

Teл.: + 359 2 953 10 34 

 

 

Luxembourg/Luxemburg  

GlaxoSmithKline Pharmaceuticals s.a./n.v. 

Belgique/Belgien 

Tél/Tel: + 32 (0) 10 85 52 00 

 

Česká republika  

GlaxoSmithKline, s.r.o. 

Tel: + 420 222 001 111 

cz.info@gsk.com 

Magyarország  

GlaxoSmithKline Kft. 

Tel.: + 36 1 225 5300 

 

Danmark  

GlaxoSmithKline Pharma A/S 

Tlf: + 45 36 35 91 00 

 

Malta  

GlaxoSmithKline (Malta) Limited 

Tel: + 356 21 238131 



28 

 

dk-info@gsk.com 

 

Deutschland  

GlaxoSmithKline GmbH & Co. KG 

Tel.: + 49 (0)89 36044 8701 

produkt.info@gsk.com 

 

Nederland  

GlaxoSmithKline BV 

Tel: + 31 (0)30 6938100 

nlinfo@gsk.com 

Eesti  

GlaxoSmithKline Eesti OÜ 

Tel: + 372 6676 900 

estonia@gsk.com  

Norge  

GlaxoSmithKline AS 

Tlf: + 47 22 70 20 00 

 

 

Ελλάδα  

GlaxoSmithKline A.E.B.E. 

Τηλ: + 30 210 68 82 100 

 

 

Österreich  

GlaxoSmithKline Pharma GmbH 

Tel: + 43 (0)1 97075 0 

at.info@gsk.com 

 

España  

GlaxoSmithKline, S.A. 

Tel: + 34 902 202 700 

es-ci@gsk.com 

 

Polska  

GSK Services Sp. z o.o. 

Tel.: + 48 (0)22 576 9000 

France  

Laboratoire GlaxoSmithKline 

Tél: + 33 (0)1 39 17 84 44 

diam@gsk.com 

 

Portugal  

GlaxoSmithKline – Produtos Farmacêuticos, Lda. 

Tel: + 351 21 412 95 00 

FI.PT@gsk.com 

Hrvatska 

GlaxoSmithKline d.o.o. 

Tel: + 385 1  6051 999 

 

România  

GlaxoSmithKline (GSK) S.R.L.  

Tel: + 4021 3028 208 

Ireland  

GlaxoSmithKline (Ireland) Limited 

Tel: + 353 (0)1 4955000 

 

Slovenija  

GlaxoSmithKline d.o.o. 

Tel: + 386 (0)1 280 25 00 

medical.x.si@gsk.com 

 

Ísland  

Vistor hf. 

Sími:  +354 535 7000 

 

Slovenská republika  

GlaxoSmithKline Slovakia s. r. o. 

Tel: + 421 (0)2 48 26 11 11 

recepcia.sk@gsk.com 

 

Italia  

GlaxoSmithKline S.p.A. 

Tel: + 39 (0)45 9218 111 

Suomi/Finland  

GlaxoSmithKline Oy 

Puh/Tel: + 358 (0)10 30 30 30 

Finland.tuoteinfo@gsk.com 

 

Κύπρος 

GlaxoSmithKline (Cyprus) Ltd 

Τηλ: + 357 22 397000 

gskcyprus@gsk.com 

Sverige 

GlaxoSmithKline AB 

Tel: + 46 (0)8 638 93 00 

info.produkt@gsk.com 

 

Latvija 

GlaxoSmithKline Latvia SIA 

Tel: + 371 67312687 

lv-epasts@gsk.com 

United Kingdom 

GlaxoSmithKline UK Ltd 

Tel: + 44 (0)800 221441 

customercontactuk@gsk.com 



29 

 

  

  

 

This leaflet was last revised in {month YYYY}. 

 

This medicine has been authorised under ‘exceptional circumstances’. 

This means that for scientific reasons it has not been possible to get complete information on this medicine. 

The European Medicines Agency will review any new information on this medicine every year and this 

leaflet will be updated as necessary. 

 

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: 

 

 

7. INFORMATION FOR HEALTHCARE PROFESSIONALS 

 

Dectova preparation 

 

• The volume of Dectova and total volume for infusion will depend on the patient’s age, weight and 
renal function (see section 4.2 of the SmPC). 

• The dose can be infused as supplied or diluted in sodium chloride 9 mg/mL (0.9%) solution for 
injection down to any concentration greater than or equal to 0.2 mg/mL. 

• Each vial is for single use only; once the seal has been broken, the remaining volume must be 
discarded. 

 

How to prepare the infusion for intravenous administration: 

 

• Use aseptic techniques throughout preparation of the dose. 

• Calculate the required dose and volume of Dectova. 

• Decide on the volume of sodium chloride 9 mg/mL (0.9%) solution for injection to be used for 
infusion. 

• Using a sterile needle and syringe, withdraw and discard a volume of sodium chloride 9 mg/mL 
(0.9%) solution for injection (equal to the volume of Dectova) from the infusion bag. 

• Infusion bags may have a further overage of sodium chloride 9 mg/mL (0.9%) solution for injection 
included – this can also be removed if considered necessary. 

• Using a sterile needle and syringe, withdraw the volume of Dectova from the vial(s) and add to the 
infusion bag. 

• Discard any unused portion of the vial. 

• The infusion bag should be gently manipulated by hand to ensure it is mixed thoroughly. 

• If refrigerated, the infusion bag should be removed from the refrigerator and brought up to room 
temperature before use. 

 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. 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
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR
	A. LABELLING
	B. PACKAGE LEAFLET