Baqsimi

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Baqsimi 3 mg nasal powder in single-dose container 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each single-dose container delivers nasal powder with 3 mg of glucagon. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Nasal powder in single-dose container (nasal powder). 
 
White to practically white powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children 
aged 4 years and over with diabetes mellitus. 
 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults, adolescents and children aged 4 years and over 
The recommended dose is 3 mg glucagon administered into one nostril. 
 
Elderly (≥ 65 years) 
No dose adjustment is required based on age.  
 
Efficacy and safety data are very limited in patients aged 65 years and absent in patients aged 75 and 
above. 
 
Renal and hepatic impairment 
No dose adjustment is required based on renal and hepatic function. 
 
Paediatric population 0 - < 4 years 
The safety and efficacy of Baqsimi in infants and children aged 0 to < 4 years have not yet been 
established. No data are available.  
 
Method of administration 
 
Nasal use only. Glucagon nasal powder is given in a single nostril. Glucagon is passively absorbed 
through the nasal mucosa. It is not necessary to inhale or breathe deeply after dosing. 
 
Instructions for administering glucagon nasal powder   
1. Remove the shrink wrap by pulling on the red stripe. 
2. Remove the single-dose container from the tube. Do not press the plunger until ready to give the 

dose. 
3. Hold the single-dose container between fingers and thumb. Do not test before use as it contains 



3 

only one dose of glucagon and cannot be reused. 
4. Insert the tip of the single-dose container gently in one of the nostrils until finger(s) touch the 

outside of the nose. 
5. Push the plunger all the way in. The dose is complete when the green line is no longer showing. 
6. If the person is unconscious, turn the person on their side to prevent choking. 
7. After giving the dose, the caregiver should call for medical help right away. 
8. When the patient has responded to treatment, give oral carbohydrate to restore liver glycogen 

and prevent relapse of hypoglycaemia. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Phaeochromocytoma (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
Phaeochromocytoma 
 
In the presence of phaeochromocytoma, glucagon may stimulate the release of catecholamines from 
the tumour. If the patient develops a dramatic increase in blood pressure, use of non-selective 
α-adrenergic blockade has been shown to be effective in lowering blood pressure.  Baqsimi is 
contraindicated in patients with phaeochromocytoma (see section 4.3). 
 
Insulinoma 
 
In patients with insulinoma, administration of glucagon may produce an initial increase in blood 
glucose. However, glucagon administration may directly or indirectly (through an initial rise in blood 
glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycaemia. A patient 
developing symptoms of hypoglycaemia after a dose of glucagon should be given glucose orally or 
intravenously. 
 
Hypersensitivity and allergic reactions  
 
Allergic reactions, which have been reported with injectable glucagon, may occur and include 
generalised rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. If 
the patient experiences difficulty breathing call for immediate medical assistance. 
 
Glycogen stores and hypoglycaemia  
 
Glucagon is effective in treating hypoglycaemia only if sufficient liver glycogen is present. Because 
glucagon is of little or no help in states of starvation, adrenal insufficiency, chronic alcohol abuse or 
chronic hypoglycaemia, these conditions should be treated with glucose. 
 
To prevent relapse of the hypoglycaemia, oral carbohydrates should be given to restore liver glycogen, 
when the patient has responded to treatment. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
 
Insulin 
Reacts antagonistically towards glucagon 
 
 
 
 



4 

Indometacin 
 
When used with indometacin, glucagon may lose its ability to raise blood glucose or may even 
produce hypoglycaemia. 
 
Beta-blockers 
 
Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood 
pressure, an increase of which will be transient because of glucagon's short half-life. 
 
Glucagon treatment results in catecholamine release from the adrenal glands, and concomitant use of 
beta-blockers could result in unopposed alpha-adrenergic stimulation and consequently, a greater 
increase in blood pressure (see section 4.4). 
 
Warfarin 
 
Glucagon may increase the anticoagulant effect of warfarin. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
Reproduction and fertility studies with glucagon nasal powder were not conducted in animals.  
 
Baqsimi can be used during pregnancy. Glucagon does not cross the human placenta barrier. The use 
of glucagon has been reported in pregnant women with diabetes and no harmful effects are known 
with respect to the course of pregnancy and the health of the unborn and the neonate.  
 
Breast-feeding 
 
Baqsimi can be used during breast-feeding  Glucagon is cleared from the bloodstream very quickly  
and thus the amount excreted in the milk of nursing mothers following treatment of severe 
hypoglycaemic reactions is expected to be extremely small. As glucagon is degraded in the digestive 
tract and cannot be absorbed in its intact form, it will not exert any metabolic effect in the child. 
 
Fertility 
 
No fertility studies have been conducted with glucagon nasal powder. 
 
Studies in rats have shown that glucagon does not cause impaired fertility. 
 
4.7 Effects on ability to drive and use machines 
 
Baqsimi has negligible influence on the ability to drive and use machines. 
 
The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia which may 
persist for a brief period after receiving treatment. This may present a risk in situations where these 
abilities are especially important, such as driving or using machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions are lacrimation increased (36 %), upper respiratory 
tract irritation (34 %), nausea (27 %), headache (21 %), and vomiting (16 %). 
 
 



5 

Tabulated list of adverse reactions 
 
Adverse reactions are listed in table 1 as MedDRA preferred term by system organ class and frequency. 
The corresponding frequency category for each adverse reaction is based on 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). 
 
Table 1. Frequency of adverse reactions of glucagon nasal powder 
 

System Organ Class Very common Common Uncommon 
Nervous system disorders Headache Dysgeusia  
Eye disorders Lacrimation 

increased 
 

Ocular hyperaemia 
Eye pruritus 

 

Respiratory, thoracic, and 
mediastinal disorders 

Upper respiratory 
tract irritationa 

  

Gastrointestinal disorders Vomiting 
Nausea 

  

Skin and subcutaneous tissue 
disorders 

 Pruritus  

Investigations  Increased systolic 
blood pressureb 
Increased diastolic 
blood pressureb 

Increased heart 
rateb 

a Upper respiratory tract irritation: rhinorrhoea, nasal discomfort, nasal congestion, nasal 
pruritus, sneezing, throat irritation, cough, epistaxis, and parosmia 

b Increases in heart rate and blood pressure: as assessed by vital sign measurements. 
Frequencies are based on shifts from pre-treatment to post-treatment values. 

 
Immunogenicity 
Overall, 5.6 % of patients developed treatment-emergent anti-glucagon antibodies. These antibodies 
were not neutralising and did not lower the efficacy of glucagon nor were they associated with the 
development of treatment-emergent adverse reactions. 
 
Paediatric population 
 
Based on data from clinical trials, the frequency, type and severity of adverse reactions observed in 
children are expected to be the same as in adults. 
 
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 
 
If overdose occurs, the patient may experience nausea, vomiting, inhibition of gastro-intestinal tract 
motility, increase in blood pressure and pulse rate. In case of suspected overdosing, serum potassium 
may decrease and should be monitored and corrected if needed. If the patient develops a dramatic 
increase in blood pressure, use of non-selective α-adrenergic blockade has been shown to be effective 
in lowering blood pressure for the short time that control would be needed (see section 4.4). 
 

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


6 

 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Pancreatic hormones, Glycogenolytic hormones, ATC code: H04AA01 
 
Mechanism of action 
 
Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby 
stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are 
necessary for glucagon to produce an anti-hypoglycaemic effect. 
 
Pharmacodynamic effects 
 
Gender and body weight had no clinically meaningful effect on the pharmacodynamics of glucagon 
nasal powder. 
 
After administration of 3 mg glucagon nasal powder in adult patients with type 1 diabetes, glucose 
levels began to rise as early as 5 minutes (figure 1). By 10 minutes, the median glucose level was 
above 3.9 mmol/L (70 mg/dL). The mean maximum glucose increase was 7.8 mmol/L (140 mg/dL). 
 
In paediatric patients with type 1 diabetes (4 to < 17 years), after administration of 3 mg glucagon 
nasal powder, glucose levels began to rise as early as 5 minutes (figure 2) with a mean maximum 
glucose increase of 5.7 mmol/L (102 mg/dL) to 7.7 mmol/L (138 mg/dL). 
 
Common cold with nasal congestion with or without concomitant use of a decongestant did not impact 
pharmacodynamics of glucagon nasal powder. 
 
Figure 1. Mean glucose concentration over time in adult patients with type 1 diabetes. 
 

 
 



7 

Figure 2. Mean glucose concentration over time in paediatric patients with type 1 diabetes. 

 
 
Clinical efficacy  
 
The adult pivotal study was a randomized, multicenter, open-label, 2-period, cross-over study in adult 
patients with type 1 diabetes or type 2 diabetes. The primary objective was to compare the efficacy of 
a single 3 mg dose of glucagon nasal powder against a 1 mg dose of intra-muscular (i.m.) glucagon in 
adult patients with type 1 diabetes. Insulin was used to reduce blood glucose levels to the 
hypoglycaemic range with a target blood glucose nadir of < 2.8 mmol/L (< 50 mg/dL). 
 
The pivotal study enrolled 83 total patients 18 to < 65 years of age. Seventy-seven patients had type 1 
diabetes, with a mean age of 32.9 years and a mean diabetes duration of 18.1 years, and 45 (58 %) 
patients were female. The mean age of patients with type 2 diabetes (n=6) was 47.8 years, with a mean 
diabetes duration of 18.8 years, and 4 (67 %) patients were female. 
 
The primary efficacy outcome measure was the proportion of patients achieving treatment success, 
which was defined as either an increase in blood glucose to ≥ 3.9 mmol/L (≥ 70 mg/dL) or an increase 
of ≥ 1.1 mmol/L (≥ 20 mg/dL) from glucose nadir within 30 minutes after receiving study glucagon, 
without receiving additional actions to increase the blood glucose level. Glucose nadir was defined as 
the minimum glucose measurement at the time of, or within 10 minutes, following glucagon 
administration. 
 
For patients with type 1 diabetes, the mean nadir blood glucose was 2.5 mmol/L (44.2 mg/dL) for 
glucagon nasal powder and 2.7 mmol/L (48.9 mg/dL) for i.m. glucagon. Glucagon nasal powder 
demonstrated non-inferiority to i.m. glucagon in reversing insulin-induced hypoglycaemia with 98.7 % 
of glucagon nasal powder-treated patients and 100 % of i.m. glucagon-treated patients achieving 
treatment success within 30 minutes (table 2). All patients met glucose treatment success criteria 
within 40 minutes. All patients with type 2 diabetes (100 %) achieved treatment success within 
30 minutes. 
 
The mean time to treatment success was 16.2 and 12.2 minutes in the glucagon nasal powder and i.m. 
glucagon 1 mg treatment groups, respectively. Time to treatment success represents the time from 
glucagon administration to patient achieving treatment success; it does not include the time for 
reconstitution and preparation of the intra-muscular injection in the control group. 
 

Time (minutes)

0 10 20 30 40 50 60 70 80 90

M
ea

n 
G

lu
co

se
 (m

m
ol

/L
)

2

4

6

8

10

12

14

M
ea

n 
G

lu
co

se
 (m

g/
dL

)

36

54

72

90

108

126

144

162

180

198

216

234

252

4 to <8 years 
8 to <12 years 
12 to <17 years



8 

By 30 minutes post glucagon administration, patients in both glucagon nasal powder and i.m. 
glucagon groups had similar improvement in symptoms of hypoglycaemia, as evaluated by Edinburgh 
Hypoglycaemia Symptom Questionnaire. 
 
Table 2. Patients meeting treatment success and other glucose criteria in pivotal study 
 

 Type 1 diabetes 
(n=75)a 

Type 1 and type 2 diabetes 
(n=80)a 

glucagon 
nasal 

powder 
3 mg 

i.m. glucagon 
1 mg 

glucagon 
nasal 

powder 
3 mg 

i.m. glucagon 
1 mg 

Treatment success – n (%) 74 (98.7 %) 75 (100 %) 79 (98.8 %) 80 (100 %) 
Treatment difference (2-sided 
95 % confidence interval)b,c 1.3% (-3.8%, 7.2%) 1.3% (-3.6%, 6.8%) 

Glucose criterion met – n (%)d     
(i) ≥ 3.9  mmol/L (≥ 70 mg/dL)   72 (97 %) 74 (99 %) 77 (97 %) 79 (99 %) 
(ii) Increase by ≥ 1.1  mmol/L 
(≥ 20 mg/dL) from nadir 74 (100 %) 75 (100 %) 79 (100 %) 80 (100 %) 

Both (i) and (ii) 72 (97 %) 74 (99 %) 77 (97 %) 79 (99 %) 
a The efficacy analysis population consisted of all patients who received both doses of the study 
medicinal product with evaluable primary outcome. 
b Difference calculated as (percentage with success in i.m. glucagon) – (percentage with success in 
glucagon nasal powder). 
c 2-sided 95 % confidence interval (CI) using the unconditional profile likelihood method based on 
‘exact’ tail areas; non-inferiority margin=10 %. 
d Percentage based on number of patients meeting treatment success. 

 
In a similarly designed clinical confirmatory study, 70 patients with type 1 diabetes were enrolled with 
a mean age of 41.7 years (20-64 years), and a mean diabetes duration of 19.8 years. Twenty-seven 
(39%) were female. Insulin was used to reduce blood glucose levels to < 3.3 mmol/L (< 60 mg/dL). 
 
The mean nadir blood glucose was 3.0 mmol/L (54.2 mg/dL) for glucagon nasal powder and 
3.1 mmol/L (55.7 mg/dL) for i.m. glucagon. Glucagon nasal powder demonstrated non-inferiority to 
i.m. glucagon in reversing insulin-induced hypoglycaemia with 100 % of glucagon nasal powder-
treated patients and 100 % of i.m. glucagon-treated patients achieving treatment success (table 3). The 
mean time to treatment success was 11.4 and 9.9 minutes in the glucagon nasal powder and i.m. 
glucagon 1 mg treatment groups, respectively. 
 



9 

Table 3. Patients meeting treatment success and other glucose criteria in confirmatory study 
 

 Type 1 diabetes 
(n=66)a 

glucagon 
nasal powder 

3 mg 

i.m. glucagon 
1 mg 

Treatment success – n (%) 66 (100 %) 66 (100 %) 
Treatment difference (2-sided 95 % confidence 
interval)b,c 

 
0 % (-5.4%, 5.4%)  

Glucose criterion met – n (%)   
(i) ≥ 3.9 mmol/L (≥70 mg/dL)   
(ii) Increase by ≥ 1.1 mmol/L (≥ 20 mg/dL) from nadir 
Both (i) and (ii) 

66 (100 %) 
66 (100 %) 
66 (100 %) 

66 (100 %) 
66 (100 %) 
66 (100 %) 

a The efficacy analysis population consisted of all patients who received both doses of the study 
medicinal product with evaluable primary outcome. 
b Difference calculated as (percentage with success in i.m. glucagon) – (percentage with success in 
glucagon nasal powder); non-inferiority margin = 10 %. 
c 2-sided 95 % confidence interval (CI) using the unconditional profile likelihood method based on 
‘exact’ tail areas. 

 
In an adult actual use study of approximately 6 months duration, 129 patients with type 1 diabetes 
(mean age, 46.6 years; range, 18 to 71 years) and their caregivers were dispensed glucagon nasal 
powder to treat moderate or severe hypoglycaemic events in the home or work setting. A total of 
157 moderate or severe hypoglycaemic events reported by 69 patients were included in the efficacy 
analysis. An episode of severe hypoglycaemia was defined as an episode wherein the person with 
diabetes is clinically incapacitated (that is, unconscious, convulsions, severe mental disorientation) to 
the point where the person requires third-party assistance to treat the hypoglycaemia. An episode of 
moderate hypoglycaemia was defined as an episode wherein the person with diabetes was showing 
signs of neuroglycopenia (that is, weakness, difficulty speaking, double vision, drowsiness, inability to 
concentrate, blurred vision, anxiety, hunger, tiredness or confusion) and had a glucometer reading of 
approximately 60 mg/dL (3.3 mmol/L) or less. In 151 (96.2 %) of these events, patients awoke or 
returned to normal status within 30 minutes following glucagon nasal powder administration. In all 
(100 %) 12 severe hypoglycaemic events, patients awoke, stopped convulsions (7 events from 
4 patients having presented with convulsions before glucagon nasal powder dosing) or returned to 
normal status within 5 to 15 minutes following glucagon nasal powder administration. 
 
Paediatric population 
 
The paediatric pivotal study was a randomized, multicenter, clinical study that assessed glucagon nasal 
powder compared to i.m. glucagon in children and adolescents with type 1 diabetes. Glucagon was 
administered after glucose reached < 4.4 mmol/L (< 80 mg/dL) on the dosing day. Efficacy was 
assessed based on percentage of patients with a glucose increase of ≥ 1.1 mmol/L (≥ 20 mg/dL) from 
glucose nadir within 30 minutes following glucagon administration. 
 
Forty-eight patients were enrolled and received at least one dose of study medicinal product. The mean 
age in the young children cohort (4 to < 8 years) was 6.5 years. In the children cohort 
(8 to < 12 years), mean age was 11.1 years and in the adolescents cohort (12 to < 17 years) mean age 
was 14.6 years. In all age cohorts, the population was predominantly male and white. 
 
Across all age groups, 3 mg glucagon nasal powder and i.m. glucagon 0.5 mg (children below 25 kg) 
or 1 mg (children 25 kg or above), demonstrated similar glycemic responses. All (100 %) patients in 
both treatment arms across all age groups achieved an increase in glucose ≥ 1.1 mmol/L (≥ 20 mg/dL) 
from glucose nadir within 20 minutes of glucagon administration. 



10 

 
The mean time to reach a glucose increase of ≥ 1.1 mmol/L (≥ 20 mg/dL) was similar between 
glucagon nasal powder and i.m. glucagon for all age groups (table 4). 
 
Table 4. Mean time to reach glucose increase of ≥ 1.1 mmol/L (≥ 20 mg/dL) from nadir in 

paediatric pivotal study 
 

Increase from 
nadir 

Mean time post-glucagon administration (minutes) 
Young children 

(4 to < 8 years old) 
Children 

(8 to < 12 years old) 
Adolescents 

(12 to < 17 years old) 
i.m. 

glucagona 
n=6 

glucagon 
nasal 

powder 
3 mg 
n=12 

i.m. 
glucagona 

n=6 

glucagon 
nasal 

powder 
3 mg 
n=12 

i.m. 
glucagona 

n=12 

glucagon 
nasal 

powder 
3 mg 
n=12 

≥ 1.1 mmol/L 
(≥ 20 mg/dL) 10.0 10.8 12.5 11.3 12.5 14.2 

a 0.5 mg or 1 mg of i.m. glucagon (based upon body weight) 
 
In a paediatric actual use study of approximately 6 months duration, 26 patients aged 4 to < 18 years 
old with type 1 diabetes (mean age, 11.7 years; range, 5 to 17 years) and their caregivers were 
dispensed 3 mg glucagon nasal powder to treat moderate including major hypoglycaemic events in the 
home or school setting. A total of 33 moderate hypoglycaemic events reported by 14 patients were 
included in the efficacy analysis. An episode of major hypoglycaemia was defined as an episode with 
neuroglycopenia symptoms and a glucose level below 50 mg/dL (2.8 mmol/L). An episode of 
moderate hypoglycaemia is defined as an episode wherein the child/adolescent with diabetes has 
symptoms and/or signs of neuroglycopenia and has a blood glucose level of ≤ 70 mg/dL (3.9 mmol/L). 
In all events, including major hypoglycaemia (8 events from 5 patients), patients returned to normal 
status within 5 to 30 minutes following glucagon nasal powder administration. 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Baqsimi in one or more subsets of the paediatric population in the treatment of severe hypoglycaemia 
(see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Glucagon absorption via the nasal route achieved mean peak plasma levels of 6130 pg/mL at 
15 minutes. 
 
Distribution 
 
The apparent volume of distribution of glucagon was approximately 885 L via the nasal route.  
 
Biotransformation 
 
Glucagon is known to be degraded in the liver, kidneys, and plasma. 
 
Elimination 
 
The mean half-life of glucagon was approximately 38 minutes via the nasal route. 
 
 
 



11 

Renal and hepatic impairment 
 
No formal studies have been performed to evaluate renal or hepatic impairment. 
 
Paediatric population 
 
In paediatric patients (4 to < 17 years), glucagon absorption via the nasal route, achieved mean peak 
plasma levels between 15 and 20 minutes.    
 
Common cold and use of degongestant 
 
Common cold with nasal congestion with or without concomitant use of a decongestant did not impact 
pharmacokinetics via the nasal route. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, and local tolerance with glucagon nasal powder. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Betadex (E459) 
Dodecylphosphocholine 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Do not store above 30 °C. 
 
Keep the single-dose container in the shrink wrapped tube until ready to use in order to protect from 
moisture.  
 
If the tube has been opened, the single-dose container may have been exposed to moisture. This could 
cause the medicinal product to not work as expected. Examine the shrink wrapped tube periodically. If 
the tube has been opened, replace the medicinal product. 
 
6.5 Nature and contents of container 
 
The single-dose container consists of polyethylene and polypropylene. The shrink wrapped tube is 
comprised of polyethylene and polypropylene containing a desiccant. 
 
Pack sizes of 1 or 2 single-dose containers. Not all pack sizes may be marketed. 
 
 
 
 
 



12 

6.6 Special precautions for disposal and other handling 
 
Instructions for use 
 
This is a ready to use medicinal product and for single-use only. 
 
The single-dose container contains only one dose and therefore it must not be primed or tested prior to 
use. 
 
The instructions for using the medicinal product in the package leaflet must be followed carefully.  
 
Discard nasal glucagon single-dose container and tube after use. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.,  
Papendorpseweg 83,  
3528 BJ Utrecht,  
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1406/001 
EU/1/19/1406/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: <{DD month YYYY}> 
 
 
10. DATE OF REVISION OF THE TEXT 
 
<{DD month YYYY}> 
 
 
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/


13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 

 



14 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 

Lilly France S.A.S., 
Rue du Colonel Lilly,  
F-67640 Fegersheim,  
France 
 
 
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 (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 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. 

 
• Additional risk minimisation measures 

 
Prior to launch of Baqsimi (glucagon), for the treatment of severe hypoglycaemia in adults, 
adolescents, and children aged 4 years and over with diabetes mellitus, in each EU Member State, the 
Marketing Authorisation Holder (MAH) must agree on the content and format of the educational 
materials, including communication media, distribution modalities, and any other aspects of the 
programme, with the National Competent Authority.  
 
The educational materials are aimed at providing guidance on how to minimise the important potential 
risk in the RMP of inappropriate use of the device leading to loss of drug benefit. 
 
The MAH shall ensure that in each Member State where Baqsimi is marketed, all healthcare 
professionals and patients/carers who are expected to prescribe, supply or use the product have access 
to the following: 



15 

• Administration leaflet;  
• Instructional video; 
• Demonstration kit that includes a trainer device with an administration leaflet unique to the 

trainer device. 
 
The administration leaflet should contain the following key elements: 

• Patients should receive the administration leaflet from their healthcare professionals upon 
initial Baqsimi prescription and after training.  

• The demonstration kit should include a leaflet unique to the trainer device. 
• It is important not to prime the single-dose container in advance, not to remove the shrink 

wrapping or to remove the single-dose container from the tube in advance and to ensure that 
the patient understands that while the trainer device used during demonstration can be 
reset/reused, each Baqsimi single-dose container can only be used once. 

• The PL/IFU should be referenced for more detailed information regarding administration and 
handling of Baqsimi. 

• Patients can use the leaflet to teach those around them how to correctly handle and administer 
Baqsimi.  

• The leaflet should contain a URL and, where required, a password to a website where patients 
can access the instructional video.     

 
The instructional video should contain the following key elements: 

• To reinforce the correct Baqsimi handling and administration, step-by-step instructions on the 
appropriate use of Baqsimi should be provided.  

 
The demonstration kit that includes a trainer device should contain the following key elements: 

• The demonstration kit consists of a trainer device, which is a non-drug containing device, and 
a box with instructions on how to use Baqsimi.  

• An administration leaflet unique to the trainer device should be included within the 
demonstration kit that includes the trainer device. 

• The trainer device should be used by healthcare professionals who prescribe and supply 
Baqsimi to educate patients and/or caregivers.  

• In addition to instructions for correct handling and administration, the demonstration kit 
should contain key points that healthcare professionals who prescribe and supply Baqsimi 
should emphasise when training patients and/or caregivers on Baqsimi (importance of not 
priming the single-dose container in advance, not removing the shrink wrapping or removing 
the single-dose container from the tube in advance and ensuring that the patient understands 
that while the trainer device used during demonstration can be reset/reused, each Baqsimi 
single-dose container can only be used once). 

• The trainer device should not be inserted into a patient’s nostril when demonstrating (that is, 
to observe prudent hygiene measures). 

  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

  



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
A. LABELLING 

  



18 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Baqsimi 3 mg nasal powder in single-dose container 
glucagon 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each single-dose container delivers nasal powder with 3 mg of glucagon. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: betadex and dodecylphosphocholine. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Nasal powder in single-dose container 
 
1 single-dose container 
2 single-dose containers 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Nasal use. 
For single use only. 
Do not press the plunger prior to insertion as you will lose the dose. 
 
 
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 
 
Do not store above 30 °C. 



19 

Keep the single-dose container in the shrink wrapped tube until ready to use in order to protect from 
moisture. 
 
 
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 
 
Eli Lilly Nederland B.V.,  
Papendorpseweg 83,  
3528 BJ Utrecht,  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1406/001 1 single-dose container 
EU/1/19/1406/002 2 single-dose containers 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Baqsimi 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



20 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
LABEL – Tube 
 
 
1. NAME OF THE MEDICINAL PRODUCT  
 
Baqsimi 3 mg nasal powder in single-dose container 
glucagon 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Nasal use 
Single use only 
 
Instructions: 
 

    
HOLD the single-dose 
container as shown.  Do not 
press plunger (A) before 
insertion. 
 

INSERT Tip (B) in one of the 
nostrils. 
 

PUSH the Plunger (A) all the 
way in until the green line is 
no longer showing. 

 
Do not remove shrink wrap until ready to use. 
Peel for instructions after giving the dose. 
 
After giving the dose: 
• If the person is unconscious, turn the person on their side after giving Baqsimi. 
• Call for medical help right away. 



21 

• Encourage the person to eat or drink a high sugar snack like sweets or fruit juice as soon as 
possible. 

• Throw away the used single-dose container and tube. 
  



22 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS  
 
LABEL – Single-dose container 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Baqsimi 3 mg nasal powder 
glucagon 
Nasal use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mg 
 
 
6. OTHER 
 
  



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

B. PACKAGE LEAFLET 



24 

Package leaflet: Information for the patient 
 

Baqsimi 3 mg nasal powder in single-dose container 
glucagon 

 
Read all of this leaflet carefully before you start using 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, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
- 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 Baqsimi is and what it is used for  
2. What you need to know before you are given Baqsimi  
3. How Baqsimi is given 
4. Possible side effects  
5. How to store Baqsimi  
6. Contents of the pack and other information 
 
 
1. What Baqsimi is and what it is used for 
 
Baqsimi contains the active substance glucagon, which belongs to a group of medicines called 
glycogenolytic hormones. It is used to treat severe hypoglycaemia (very low blood sugar) in people 
with diabetes. It is for use in adults, adolescents, and children aged 4 years or older. 
 
Glucagon is a natural hormone produced by the pancreas. It works in the opposite way to insulin and 
raises blood sugar. It does this by converting stored sugar in the liver called glycogen to glucose (a 
form of sugar that the body uses for energy). The glucose then enters the bloodstream and raises the 
blood sugar level, so reducing the effects of hypoglycaemia. 
 
You should always carry Baqsimi with you and tell your friends and family that you are carrying it. 
 
 
2. What you need to know before you are given Baqsimi 
 
Important information 
If you are at risk of severe hypoglycaemia you should always have Baqsimi readily available:  
- show your family members, friends, or people you work with where you keep this medicine and 

explain when and how to use it. Delay in treatment may be harmful. It is important they know 
how to use Baqsimi before you need it. 

 
Do not use Baqsimi 
- if you are allergic to glucagon or any of the other ingredients of this medicine (listed in 

section 6). 
- if you have phaeochromocytoma, which is a tumour in the adrenal gland (a gland above your 

kidneys). 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using Baqsimi: 
- if you have a tumour in your pancreas called insulinoma. 
- if you have insufficient liver glycogen. This could occur: 



25 

- in states of starvation.   
- if your adrenal gland does not produce enough cortisol or aldosterone.  
- if you suffer from chronic hypoglycaemia. 

 
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before 
using Baqsimi. 
 
After using Baqsimi, eat as soon as possible to prevent the recurrence of low blood sugar. Take a fast-
acting source of sugar, such as fruit juice or a sugar-containing carbonated drink. 
 
Children 
Baqsimi is not recommended for children under 4 years of age because it has not been studied in this 
age group. 
 
Other medicines and Baqsimi 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
The following medicines can affect the way Baqsimi works: 
- insulin – used to treat diabetes. Insulin has the opposite effect of glucagon on blood sugar. 
- indometacin, used to treat joint pain and stiffness. Indometacin reduces the effect of glucagon. 
 
The following medicines may be affected by Baqsimi: 
- warfarin, used to prevent blood clots. Baqsimi may increase the anticlotting effect of warfarin. 
- beta-blockers, used to treat high blood pressure and irregular heart beat. Baqsimi may increase 

blood pressure and pulse.  This will only last a short time. 
 
Pregnancy and breast-feeding 
If your blood sugar drops very low when you are pregnant or breast-feeding, you can use Baqsimi. 
 
Driving and using machines 
Wait until the effects of very low blood sugar have worn off, before driving or using any tools or 
machines. 
 
 
3. How Baqsimi is given 
 
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your 
doctor, pharmacist or nurse if you are not sure. 
 
Explain how to use Baqsimi to your family, friends, co-workers or care-giver. They will need to know 
how to use it before you need it. 
 
Baqsimi is given as a single 3 mg dose. 
 
Instructions for giving Baqsimi  
1. Remove the shrink wrap by pulling on the red stripe. 
2. Open the lid and remove the single-dose container from the tube. 
Caution: Do not press the plunger before insertion into the nose, otherwise the single dose in the 
single-dose container will be lost. 

 
Giving the dose 
 
1. Hold the single-dose container between fingers and thumb. Do not test before use as it contains 

only one dose of glucagon and cannot be reused. 
2. Insert the tip gently into a nostril until the finger touches the outside of the nose. 
3. Push the plunger all the way in with your thumb. The dose is complete when the green line no 

longer shows on the plunger. 



26 

4. If the person with the low blood sugar is unconscious, turn the person to their side to prevent 
choking. 

5. After giving the dose, call for medical help right away. 
6. Encourage the person with the low blood sugar to eat as soon as possible. A high sugar snack 

will stop another fall in blood sugar level. 
 
Read the “Instructions for Use” carefully before using Baqsimi. 
 
If you are given more Baqsimi than you should 
Too much Baqsimi may cause nausea and vomiting. It may also raise your blood pressure and pulse 
rate. Specific treatment is not usually necessary. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Very common side effects that may affect more than 1 in 10 people using this medicine are: 
- Nausea (feeling sick) and vomiting (being sick) 
- Headache 
- Discomfort and other effects in the nose, including itchiness, sneezing, runny or blocked nose 

and bleeding 
- Altered sense of smell 
- Throat irritation and cough 
- Watery eyes 
 
Common side effects that may affect up to 1 in 10 people using this medicine are: 
- Increased blood pressure 
- Itchy and red eyes 
- Itchy skin 
- Altered sense of taste 
 
Uncommon side effects that may affect up to 1 in 100 people using this medicine 
- Increase heart rate  
 
Reporting of side effects 
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 Baqsimi 
 
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, tube and single-dose 
container after EXP. The expiry date refers to the last day of that month. 
 
Do not store above 30 °C. 
 
Keep the single-dose container in the shrink wrapped tube until ready to use in order to protect from 
moisture.  
 
If the tube has been opened, the single-dose container may have been exposed to moisture. This could 

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


27 

cause the medicinal product to not work as expected. Examine the shrink wrapped tube periodically. If 
the tube has been opened, replace the medicinal product. 
 
Do not throw away any medicines via wastewater or household waste. Ask your 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 Baqsimi contains 
- The active substance is glucagon. Each single-dose container delivers nasal powder with 3 mg 

of glucagon. 
- The other ingredients are betadex and dodecylphosphocholine. 
 
What Baqsimi looks like and contents of the pack 
Baqsimi is a white to practically white nasal powder in single-dose container (nasal powder). 
Each single-dose container contains a single dose of glucagon nasal powder. 
Baqsimi is packed in a carton containing 1 or 2 single-dose containers individually sealed in a plastic 
tube. Not all pack sizes may be available in your country. 
 
Marketing Authorisation Holder 
Eli Lilly Nederland B.V.,  
Papendorpseweg 83,  
3528 BJ Utrecht,  
The Netherlands 
 
Manufacturer 
Lilly France S.A.S.,  
Rue du Colonel Lilly,  
F-67640 Fegersheim,  
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 



28 

Eesti 
Eli Lilly Nederland B.V.  
Tel: +372 6 817 280 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 
 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 

Ísland 
Icepharma hf. 
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
 
This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 



29 

INSTRUCTIONS FOR USE 
 

Baqsimi 3 mg nasal powder in single-dose container 
glucagon 

 
Read the instructions for use before using Baqsimi. Also read the package leaflet in full 
before using the medicine. 
 

• Show your family and friends where you keep Baqsimi and explain how to use it by sharing 
these instructions. They need to know how to use it before you need it. 

• Baqsimi is used to treat severe low blood sugar (hypoglycaemia). 
IMPORTANT POINTS TO KNOW 

• Keep the single-dose container in the shrink wrapped tube until it needs to be used use in order 
to protect from moisture. 

• If the tube has been opened, moisture may have got into the single-dose container and medicine 
may not work properly. 

• Baqsimi contains only 1 dose of glucagon so do not press plunger before inserting into nose 
• Baqsimi is for use in the nose and for single use only. 
 

PREPARING THE DOSE 

 

• Remove the shrink wrap by 
pulling on red stripe. 

 

• Open the lid and remove the 
single-dose container from the 
tube. 

 
 Caution: Do not press 

the plunger before 
insertion into the 
nose. 
Otherwise the single 
dose in the single-dose 
container will be lost 

  

Tube 

Single-dose container 



30 

GIVING THE DOSE 

 

• Hold the single-dose 
container between 
fingers. Do not press 
plunger (A) or test 
single-dose container. 

 

• Insert the tip (B) gently 
in a nostril until the 
finger touches the 
outside of the nose. 

 
 

• Push the plunger (A) all 
the way in with your 
thumb. 

 
• The dose is complete 

when the green line on 
the plunger no longer 
shows. 

  

AFTER GIVING THE DOSE 
• If the person with the low blood sugar is unconscious, turn the person to their side after giving 

Baqsimi. 
• Remove the tip from nose.  
• Call for medical help right away. 
• Encourage the person with the low blood sugar to eat or drink a high sugar snack like sweets or 

fruit juice as soon as possible. 
• Throw away the used single-dose container and tube. 

 
STORAGE AND HANDLING 

• Do not remove the shrink wrapping or open the tube until ready to give the dose. 

Tip (B) 

Plunger (A)  
Green line 



31 

• Store the single-dose container in the shrink wrapped tube at temperatures up to 30 ºC.  
• Replace Baqsimi before the expiry date printed on the tube or carton. 
 

 Expiry Date 

 
 

OTHER INFORMATION 
• Caution: Replace the used Baqsimi right away so you will have a new Baqsimi in case you 

need it. 
• Keep Baqsimi out of the sight and reach of children. 
 

FOR QUESTIONS OR MORE INFORMATION ABOUT BAQSIMI 
• Ask your healthcare provider 
 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	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  
	A. LABELLING
	B. PACKAGE LEAFLET