Deltyba

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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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 
 
Deltyba 50 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 50 mg delamanid. 
 
Excipient with known effect: each film-coated tablet contains 100 mg lactose (as monohydrate). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Round, yellow, film-coated tablet. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug 
resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be 
composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). 
 
Consideration should be given to official guidance on the appropriate use of antibacterial agents. 
 
4.2 Posology and method of administration 
 
Treatment with delamanid should be initiated and monitored by a physician experienced in the management 
of multidrug-resistant Mycobacterium tuberculosis. 
 
Delamanid must always be administered as part of an appropriate combination regimen for the treatment of 
multidrug-resistant tuberculosis (MDR-TB) (see sections 4.4 and 5.1). Treatment with an appropriate 
combination regimen should continue after completion of the 24-week delamanid treatment period according 
to WHO guidelines. 
 
It is recommended that delamanid is administered by directly observed therapy (DOT). 
 
Posology 
The recommended dose for adults is 100 mg twice daily for 24 weeks. 
 
Elderly patients (> 65 years of age) 
No data are available in the elderly.  
 
Renal impairment 
No dose adjustment is considered necessary in patients with mild or moderate renal impairment. There are no 



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data on the use of delamanid in patients with severe renal impairment and its use is not recommended (see 
sections 4.4 and 5.2). 
 
Hepatic impairment 
No dose adjustment is considered necessary in patients with mild hepatic impairment. Delamanid is not 
recommended in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2). 
 
Paediatric population 
The safety and efficacy of delamanid in children and adolescents below 18 years has not yet been 
established. 
No data are available. 
 
Method of administration  
For oral use. 
Delamanid should be taken with food. 
 
4.3 Contraindications 
 
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
- Serum albumin < 2.8 g/dL (see section 4.4 regarding use in patients with serum albumin ≥2.8 g/dL) 
- Taking medicinal products that are strong inducers of CYP3A4 (e.g. carbamazepine). 
 
4.4 Special warnings and precautions for use 
 
There are no data on treatment with delamanid for more than 24 consecutive weeks.  
 
There are no clinical data on the use of delamanid to treat  
- extra pulmonary tuberculosis (e.g. central nervous system, bone)  
- infections due to Mycobacterial species other than those of the M. tuberculosis complex 
- latent infection with M. tuberculosis 
There are no clinical data on the use of delamanid as part of combination regimens used to treat drug-
susceptible M. tuberculosis. 
 
Resistance to delamanid 
Delamanid must only be used in an appropriate combination regimen for MDR-TB treatment as 
recommended by WHO to prevent development of resistance to delamanid. 
 
QT prolongation 
QT prolongation has been observed in patients treated with delamanid. This prolongation increases slowly 
over time in the first 6-10 weeks of treatment and remains stable therafter. QTc prolongation is very closely 
correlated with the major delamanid metabolite DM-6705. Plasma albumin and CYP3A4 regulate the 
formation and metabolism of DM-6705 respectively (see Special Considerations below). 
 
General recommendations 
It is recommended that electrocardiograms (ECG) should be obtained before initiation of treatment and 
monthly during the full course of treatment with delamanid. If a QTcF >500 ms is observed either before the 
first dose of delamanid or during delamanid treatment, treatment with delamanid should either not be started 
or should be discontinued. If the QTc interval duration exceeds 450/470 ms for male/female patients during 
delamanid treatment, these patients should be administered more frequent ECG monitoring. It is also 
recommended that serum electrolytes, e.g. potassium, are obtained at baseline and corrected if 
abnormal. 
 
Special Considerations 
 
Cardiac risk factors 



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Treatment with delamanid should not be initiated in patients with the following risk factors unless the 
possible benefit of delamanid is considerd to outweigh the potential risks. Such patients should receive very 
frequent monitoring of ECG throughout the full delamanid treatment period. 
- Known congenital prolongation of the QTc-interval or any clinical condition known to prolong the 

QTc interval or QTc > 500 ms.  
- History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.  
- Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular 

hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by 
reduced left ventricle ejection fraction.  

- Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia. 
- Taking medicinal products that are known to prolong the QTc interval. These include (but are not 

limited to): 
-  Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, 

hydroquinidine, sotalol). 
- Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, 
 mesoridazine, pimozide, or thioridazine), antidepressive agents. 
- Certain antimicrobial agents, including: 

- macrolides (e.g. erythromycin, clarithromycin) 
- moxifloxacin, sparfloxacin (see section 4.4 regarding use with other fluoroquinolones) 
- bedaquiline 
- triazole antifungal agents 
- pentamidine 
- saquinavir 

- Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine) 
- Certain antimalarials with QT-prolonging potential (e.g. halofantrine, quinine, chloroquine, 

artesunate/amodiaquine, dihydroartemisinin/piperaquine). 
-  Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca 

alkaloids, arsenic trioxide. 
 
Hypoalbuminaemia 
In a clinical study, the presence of hypoalbuminaemia was associated with an increased risk of prolongation 
of the QTc interval in delamanid treated patients. Delamanid is contraindicated in patients with albumin 
<2.8 g/dL (see section 4.3). Patients who commence delamanid with serum albumin <3.4 g/dL or experience 
a fall in serum albumin into this range during treatment should receive very frequent monitoring of ECGs 
throughout the full delamanid treatment period. 
 
Co-administration with strong inhibitors of CYP3A4 
Co-administration of delamanid with a strong inhibitor of CYP3A4 (lopinavir/ritonavir) was associated with 
a 30% higher exposure to the metabolite DM-6705, which has been associated with QTc prolongation. 
Therefore if co-administration of delamanid with any strong inhibitor of CYP3A4 is considered necessary it 
is recommended that there is very frequent monitoring of ECGs, throughout the full delamanid treatment 
period. 
 
Co-administration of delamanid with quinolones 
All QTcF prolongations above 60 ms were associated with concomitant fluoroquinolone use. Therefore if co-
administration is considered to be unavoidable in order to construct an adequate treatment regimen for MDR-
TB it is recommended that there is very frequent monitoring of ECGs throughout the full delamanid 
treatment period. 
 
Hepatic impairment 
Deltyba is not recommended in patients with moderate to severe hepatic impairment (see sections 4.2 and 
5.2). 
 
Biotransformation and elimination 
The complete metabolic profile of delamanid in man has not yet been fully elucidated (see sections 4.5 and 
5.2). Therefore the potential for drug-drug interactions of clinical significance to occur with delamanid and 



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the possible consequences, including the total effect on the QTc interval, cannot be predicted with 
confidence. 
 
Excipients 
Deltyba film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, 
the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
The complete metabolic profile and mode of elimination of delamanid has not yet been fully elucidated (see 
sections 4.4 and 5.2) 
 
Effects of other medicinal products on Deltyba 
 
Cytochrome P450 3A4 inducers 
Clinical drug-drug interactions studies in healthy subjects indicated a reduced exposure to delamanid, of up 
to 45% following 15 days of concomitant administration of the strong inducer of cytochrome P450 (CYP) 
3A4 (Rifampicin 300 mg daily) with delamanid (200 mg daily). No clinically relevant reduction in 
delamanid exposure was observed with the weak inducer efavirenz when administered at a dose of 600 mg 
daily for 10 days in combination with delamanid 100 mg twice daily. 
 
Anti-HIV medicines 
In clinical drug-drug interaction studies in healthy subjects, delamanid was administered alone (100 mg 
twice daily) and with tenofovir disoproxil (245 mg daily) or lopinavir/ritonavir (400/100 mg daily) for 14 
days and with efavirenz for 10 days (600 mg daily). Delamanid exposure remained unchanged (<25% 
difference) with anti-HIV medicines tenofovir disoproxil and efavirenz but was slightly increased with the 
combination anti-HIV medicine containing lopinavir/ritonavir. 
 
Effects of Deltyba on other medicinal products 
 
In-vitro studies showed that delamanid did not inhibit CYP450 isozymes. 
In-vitro studies showed that delamanid and metabolites did not have any effect on the transporters MDR1(p-
gp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 and BSEP, at concentrations of 
approximately 5 to 20 fold greater than the Cmax at steady state. However, since the concentrations in the gut 
can potentially be much greater than these multiples of the Cmax, there is a potential for delamanid to have an 
effect on these transporters. 
 
Anti-Tuberculosis medicines 
In a clinical drug-drug interaction study in healthy subjects, delamanid was administred alone (200 mg daily) 
and with rifampicin/isoniazid/pyrazinamide (300/720/1800 mg daily) or ethambutol (1100 mg daily) for 15 
days. Exposure of concomitant anti-TB drugs (rifampicin [R]/ isoniazid [H]/ pyrazinamide [Z]) was not 
affected. Co-administration with delamanid significantly increased steady state plasma concentrations of 
ethambutol by approximately 25%, the clinical relevance is unknown. 
 
Anti-HIV medicines 
In a clinical drug-drug interaction study in healthy subjects, delamanid was administred alone (100 mg twice 
daily) and tenofovir disoproxil (245 mg daily), lopinavir/ritonavir (400/100 mg daily) for 14 days and with 
efavirenz for 10 days (600 mg daily). Delamanid given in combination with the anti-HIV-medicines, 
tenofovir disoproxil, lopinavir/ritonavir and efavirenz, did not affect the exposure to these medicinal 
products. 
 
Medicinal products with the potential to prolong QTc 
Care must be taken in using delamanid in patients already receiving medicines associated with QT 
prolongation (see section 4.4). Co-administration of moxifloxacin and delamanid in MDR-TB patients has 
not been studied. Moxifloxacin is not recommended for use in patients treated with delamanid 
 



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4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are very limited data from the use of delamanid in pregnant women. Studies in animals have shown 
reproductive toxicity (see section 5.3). 
Deltyba is not recommended in pregnant women or in women of childbearing potential unless they are using 
a reliable form of contraception. 
 
Breast-feeding 
It is unknown whether this medicinal product or its metabolites are excreted in human milk. Available 
pharmacokinetic data in animals have shown excretion of delamanid and/or its metabolites in milk. Because 
a potential risk to the breast-feeding infant cannot be ruled out , it is recommended that women should not 
breastfeed during treatment with Deltyba. 
 
Fertility 
Deltyba had no effect on male or female fertility in animals (see section 5.3). There are no clinical data on 
the effects of delamanid on fertility in humans. 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. However, patients 
should be advised not to drive or use machines if they experience any adverse reaction with a potential 
impact on the ability to perform these activities (e.g. headache and tremor are very common). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most frequently observed adverse drug reactions in patients treated with delamanid + Optimised 
Background Regimen (OBR) (i.e. incidence > 10%) are nausea (32,9%), vomiting (29,9%), headache (27.6%), 
insomnia (27.3%), dizziness (22.4%), tinnitus (16.5%), hypokalaemia (16.2%), gastritis (15.0%), decreased 
appetite (13.1%), and asthenia (11.3%). 
 
Tabulated list of adverse reactions 
The list of adverse drug reactions and frequencies are based on the results from 2 double-blind placebo 
controlled clinical trials (delamanid plus OBR, n = 662 vs placebo plus OBR n = 330). The adverse drug 
reactions are listed by MedDRA System Organ Class and Preferred Term. Within each System Organ Class, 
adverse reactions are listed under frequency categories of 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 the available data). Within each frequency grouping, adverse reactions are presented in order 
of decreasing seriousness. 
 
Table: Adverse drug reactions to delamanid 
 

System Organ 
Class 

Frequency 
uncommon 

Frequency 
common 

Frequency 
very common 

Infections and 
infestations 

Herpes zoster 
Oropharyngeal candidiasis 
Tinea versicolor* 

  

Blood and 
lymphatic 
system disorders 

Leukopenia 
Thrombocytopaenia 

Anaemia* 
Eosinophilia* 

Reticulocytosis 

Metabolism and 
nutrition 
disorders 

Dehydration 
Hypocalcaemia 
Hypercholesterolaemia 

Hypertriglyceridaemia Hypokalaemia 
Decreased 
appetite 
Hyperuricaemia* 



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Psychiatric 
disorders 

Aggression 
Delusional disorder, persecutory 
type 
Panic disorder 
Adjustment disorder with 
depressed mood 
Neurosis 
Dysphoria 
Mental disorder 
Sleep disorder 
Libido increased* 
 

Psychotic disorder 
Agitation 
Anxiety and anxiety 
disorder 
Depression and depressed 
mood 
Restlessness 

Insomnia 

Nervous system 
disorders 

Lethargy 
Balance disorder 
Radicular pain 
Poor quality sleep 

Neuropathy peripheral 
Somnolence* 
Hypoaesthesia 
 

Dizziness* 
Headache 
Paraesthesia 
Tremor 

Eye disorders Conjunctivitis allergic* Dry eye* 
Photophobia 

 

Ear and 
labyrinth 
disorders 

 Ear pain Tinnitus 

Cardiac 
disorders 

Atrioventricular block first degree 
Ventricular extrasystoles* 
Supraventricular extrasystoles 

 Palpitations 

Vascular 
disorders 

 Hypertension 
Hypotension 
Haematoma* 
Hot flush* 

 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Dyspnoea 
Cough 
Oropharyngeal pain 
Throat irritation 
Dry throat* 
Rhinorrhoea* 

Haemoptysis 

Gastrointestinal 
disorders 

Dysphagia 
Paraesthesia oral 
Abdominal tenderness* 

Gastritis* 
Constipation* 
Abdominal pain 
Abdominal pain lower 
Dyspepsia 
Abdominal discomfort 

Vomiting 
Diarrhoea* 
Nausea 
Abdominal pain 
upper 

Hepatobiliary 
disorders 

Hepatic function abnormal   

Skin and 
subcutaneous 
tissue disorders 

Alopecia* 
Eosinophilic pustular folliculitis* 
Pruritus generalised* 
Rash erythematous 

Dermatitis 
Urticaria 
Rash pruritic* 
Pruritus* 
Rash maculo-papular* 
Rash* 
Acne 
Hyperhidrosis 

 

Musculoskeletal 
and connective 
tissue disorders 

 Osteochondrosis 
Muscular weakness 
Musculoskeletal pain* 
Flank pain 
Pain in extremity 

Arthralgia* 
Myalgia* 



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Renal and 
urinary 
disorders 

Urinary retention 
Dysuria* 
Nocturia 

Haematuria* 
 

 

General 
disorders and 
administration 
site conditions 

Feeling hot Pyrexia* 
Chest pain 
Malaise 
Chest discomfort* 
Oedema peripheral* 

Asthenia 

Investigations Electrocardiogram ST segment 
depression 
Transaminases increased* 
Activated partial thromboplastin 
time prolonged* 
Gamma-glutamyltransferase 
increased* 
Blood cortisol decreased 
Blood pressure increased 

Blood cortisol increased Electrocardiogra
m QT prolonged 

* The frequency for these events was lower for the combined delamanid plus OBR group in comparison to the 
placebo plus OBR group. 
 
Description of selected adverse reactions 
 
ECG QT interval prolongation 
In patients receiving 200 mg delamanid total daily dose in the phase 2 and 3 trials, the mean placebo 
corrected increase in QTcF from baseline ranged from 4.7 - 7.6 ms at 1 month and 5.3 ms - 12.1 ms at 2 
months, respectively. The incidence of a QTcF interval > 500 ms ranged from 0.6% (1/161) - 2.1% (7/341) 
in patients receiving delamanid 200 mg total daily dose versus 0% (0/160) - 1.2% (2/170) of patients 
receiving placebo + OBR, while the incidence of QTcF change from baseline > 60ms ranged from 3.1% 
(5/161) - 10.3% (35/341) in patients receiving delamanid 200 mg total daily dose versus 0% (0/160) - 7.1% 
(12/170) in patients receiving placebo. 
 
Palpitations 
For patients receiving 100 mg delamanid + OBR twice daily, the frequency was 8.1% (frequency category 
common) in comparison to a frequency of 6.3% in patients receiving placebo + OBR twice daily. 
 
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 
 
No cases of delamanid overdose have been observed in clinical trials. However, additional clinical data 
showed that in patients receiving 200 mg twice daily, i.e. total 400 mg delamanid per day, the overall safety 
profile is comparable to that in patients receiving the recommended dose of 100 mg twice daily. Albeit, some 
reactions were observed at a higher frequency and the rate of QT prolongation increased in a dose-related 
manner. Treatment of overdose should involve immediate measures to remove delamanid from the 
gastrointestinal tract and supportive care as required. Frequent ECG monitoring should be performed. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antimycobacterials, antibiotics, ATC code: J04AK06. 

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


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Mode of action 
The pharmacological mode of action of delamanid involves inhibition of the synthesis of the mycobacterial 
cell wall components, methoxy-mycolic and keto-mycolic acid. The identified metabolites of delamanid do 
not show anti-mycobacterial activity. 
 
Activity against specific pathogens 
Delamanid has no in vitro activity against bacterial species other than mycobacteria. 
 
Resistance 
Mutation in one of the 5 coenzyme F420 genes is suggested as the mechanism for resistance against 
delamanid in mycobacteria. In mycobacteria, the in vitro frequencies of spontaneous resistance to delamanid 
were similar to those for isoniazid, and were higher than those for rifampicin. Resistance to delamanid has 
been documented to occur during treatment (see section 4.4). Delamanid does not show cross-resistance with 
any of the currently used anti-tuberculosis drugs. 
 
Susceptibility testing breakpoints 
In clinical trials resistance to delamanid has been defined as any growth in the presence of a delamanid 
concentration of 0.2 μg/mL that is greater than 1% of that on drug-free control cultures on Middlebrook 
7H11 medium. 
 
Data from clinical studies 
Delamanid has been evaluated in two, double-blind, placebo controlled trials for the treatment of MDR TB. 
The analyses of SCC were conducted on the modified intent to treat population which included patients who 
had positive cultures at baseline and the isolate was resistant to both isoniazid and rifampicin, i.e., had MDR 
TB.  
 
In the first trial (Trial 204), 64/141 (45.4%) patients randomised to receive delamanid 100 mg BID + OBR 
and 37/125 (29.6%) of patients randomised to receive placebo (PLC) + OBR achieved two-month sputum 
culture conversion (SCC) (i.e. growth of Mycobacterium tuberculosis to no growth over the first 2 months 
and maintained for 1 more month) (p=0.0083). The time to SCC for the group randomised to 100 mg BID 
was also found to be faster than for the group randomised to receive placebo + OBR (p=0.0056). 
 
In the second trial (Trial 213), delamanid was administered orally at 100 mg BID as an add-on therapy to an 
OBR for 2 months followed by 200 mg once daily for 4 months. The median time to SCC was 51 days in the 
delamanid + OBR group compared with 57 days in the PLC + OBR group (p = 0.0562 using the stratified 
modified Peto-Peto modification of Gehan’s Wilcoxon rank sum test). The proportion of patients achieving 
SCC (sputum culture conversion) after the 6-month treatment period was 87.6% (198/226) in the delamanid 
+ OBR treatment group compared to 86.1% (87/101) in the placebo + OBR treatment group (p=0.7131).  
All missing cultures up to the time of SCC were assumed to be positive cultures in the primary analysis. Two 
sensitivity analyses were conducted - a last-observation-carried-forward (LOCF) analysis and an analysis 
using “bookending” methodology (which required that the previous and subsequent cultures were both 
observed negative cultures to impute a negative result, otherwise a positive result was imputed). Both 
showed a 13-day shorter median time to SCC in the delamanid + OBR group (p=0.0281 for LOCF and 
p=0.0052 for “bookending”). 
 
Delamanid resistance (defined as MIC ≥ 0.2 µg/ml) has been observed at baseline in 2 of 316 patients in 
Trial 204 and 2 of 511 patients in Trial 213 (4 of 827 patients [0.48%]). Delamanid resistance emerged in 4 
of 341 patients (1.2%) randomised to receive delamanid for 6 months in Trial 213. These four patients were 
only receiving two other medicinal products in addition to delamanid. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with Deltyba in 
one or more subsets of the paediatric population in {treatment in multi-drug resistant tuberculosis} (see 
section 4.2 for information on paediatric use). 
 



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This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that 
further evidence on this medicinal product is awaited. 
The European Medicines Agency will review new information on this medicinal product at least every year 
and this SmPC will be updated as necessary. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Oral bioavailability of delamanid improves when administered with a standard meal, by about 2.7 fold 
compared to fasting conditions. Delamanid plasma exposure increases less than proportionally with 
increasing dose. 
 
Distribution 
Delamanid highly binds to all plasma proteins with a binding to total proteins of ≥99.5%. Delamanid has a 
large apparent volume of distribution (Vz/F of 2,100 L). 
 
Biotransformation 
Delamanid is primarily metabolised in plasma by albumin and to a lesser extent by CYP3A4. The complete 
metabolic profile of delamanid has not yet been elucidated, and there is a potential for drug interactions with 
other co-administered medications, if significant unknown metabolites are discovered. The identified 
metabolites do not show anti-mycobacterial activity but some contribute to QTc prolongation, mainly DM-
6705. Concentrations of the identified metabolites progressively increase to steady state after 6 to 10 weeks.  
 
Elimination 
Delamanid disappears from plasma with a t1/2 of 30-38 hours. Delamanid is not excreted in urine. 
 
Special populations 
 
Paediatric population 
No studies have been performed in paediatric patients. 
 
Patients with renal impairment 
Less than 5% of an oral dose of delamanid is recovered from urine. Mild renal impairment (50 mL/min < 
CrCLN < 80 mL/min) does not appear to affect delamanid exposure. Therefore no dose adjustment is needed 
for patients with mild or moderate renal impairment. It is not known whether delamanid and metabolites will 
be significantly removed by haemodialysis or peritoneal dialysis. 
 
Patients with hepatic impairment 
No dose adjustment is considered necessary for patients with mild hepatic impairment. Delamanid is not 
recommended in patients with moderate to severe hepatic impairment. 
 
Elderly patients (≥ 65 years) 
No patients of ≥ 65 years of age were included in clinical trials. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no specific hazard for humans based on conventional studies for genotoxicity and 
carcinogenic potential. Delamanid and/or its metabolites have the potential to affect cardiac repolarisation 
via blockade of hERG potassium channels. In the dog, foamy macrophages were observed in lymphoid tissue 
of various organs during repeat-dose toxicity studies. The finding was shown to be partially reversible; the 
clinical relevance of this finding is unknown. Repeat-dose toxicity studies in rabbits revealed an inhibitory 
effect of delamanid and/or its metabolites on vitamin K-dependent blood clotting. In rabbits reproductive 
studies, embryo-fetal toxicity was observed at maternally toxic dosages. Pharmacokinetic data in animals 
have shown excretion of delamanid /metabolites into breast milk. In lactating rats, the Cmax for delamanid 
in breast milk was 4-fold higher than that of the blood. 
 



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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core  
Hypromellose phthalate  
Povidone 
all-rac-α-Tocopherol 
Cellulose, microcrystalline  
Sodium starch glycolate (type A)  
Carmellose calcium 
Silica, colloidal hydrated 
Magnesium stearate 
Lactose monohydrate 
 
Film coating  
Hypromellose  
Macrogol 8000 
Titanium dioxide 
Talc 
Iron oxide yellow (E172) 
 
6.2 Incompatibilities 
 
Not applicable  
 
6.3 Shelf life 
 
5 years 
 
6.4 Special precautions for storage 
 
Store in the original package in order to protect from moisture. 
 
6.5 Nature and contents of container  
 
Aluminium/Aluminium blister: 
48 tablets. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Otsuka Novel Products GmbH  
Erika-Mann-Straße 21 
80636 München 
Germany 
 
 



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8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/875/004 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 28 April 2014 
Date of latest renewal: 2 April 2019 
 
 
10. DATE OF REVISION OF THE TEXT 
 
<{MM/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/


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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 CONDITIONAL MARKETING AUTHORISATION 



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A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Otsuka Novel Products GmbH  
Erika-Mann-Straße 21 
80636 München 
Germany 
 
AndersonBrecon (UK) Ltd. 
Wye Valley Business Park 
Brecon Road 
Hay-on-Wye 
Hereford 
HR3 5PG 
United Kingdom 
 
R-Pharm Germany GmbH 
Heinrich-Mack-Straße 35 
89257 Illertissen 
Germany 
 
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 products subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION  
 
• Periodic safety update reports  
 
The marketing authorisation holder shall submit the first periodic safety update report for this product 
within 6 months following authorisation. Subsequently, the marketing authorisation holder shall submit 
periodic safety update reports for this product in accordance with the requirements set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and 
published on the European medicines web-portal. 
 
 
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.  



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If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time. 
 
• Additional risk minimisation measures 

 
The MAH should agree the educational material with the Member States, prior to launch. 
 
In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the 
educational material with the national competent authority and implement it prior to launch. 
 
The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or 
administration of Deltyba are provided with educational material. 
 
1. The Educational material for Healthcare Providers (HCPs) shall address the following key elements: 
 

• SmPC 
• Drug- resistance 
• Risk of QT interval prolongation 
• Drug use during pregnancy 
• Drug use during breast feeding. 

 
2. The educational material for Patients to be provided via the HCPs to reinforce and supplement the 
information provided in the patient information leaflet. It shall address the following key elements: 
 

• Drug use during pregnancy 
• Drug use during breast feeding. 

 
 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR 

THE CONDITIONAL MARKETING AUTHORISATION  
 
This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 
726/2004, the MAH shall complete, within the stated timeframe, the following measures: 
 
Description Due date 
 
In order to further investigate the use of delamanid in different combination treatment 
regimens as well as safety, the MAH should submit the results of the endTB 
(Evaluating Newly approved Drugs for multidrug-resistant TB) study, a randomized, 
controlled Phase III trial in adults and adolescents with multi-drug-resistant 
tuberculosis conducted by Médecins Sans Frontières, including an additional analysis 
of the data with a focus on the evaluation of delamanid based on an agreed statistical 
analysis plan.  
 

 
Q1 2022 

 

 
In order to further characterise the PK/PD relationship of delamanid, the MAH should 
conduct and submit the results of an in vitro study using the HFS-TB model. 
 

 
Q4 2020 

 
  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



18 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTONS FOR BLISTER PACKS  
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Deltyba 50 mg film-coated tablets  
delamanid 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains: 50 mg delamanid 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
48 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
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 
 
Not applicable. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from moisture. 
 
 



19 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
None 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Novel Products GmbH 
Erika-Mann-Straße 21, 80636 München 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/875/004 
 
 
13. BATCH NUMBER<, DONATION AND PRODUCT CODES> 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Deltyba 50 mg 
 
 
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 
 
Aluminium/Aluminium 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Deltyba 50 mg film-coated tablets  
delamanid 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Short title: OTSUKA 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER<, DONATION AND PRODUCT CODES> 
 
LOT 
 
 
5. OTHER 
 
  



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



22 

Package leaflet: Information for the patient 
 

Deltyba 50 mg film-coated tablets 
delamanid 

 
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 start taking 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 Deltyba is and what it is used for  
2. What you need to know before you take Deltyba  
3. How to take Deltyba  
4. Possible side effects  
5. How to store Deltyba  
6. Contents of the pack and other information 
 
 
1. What Deltyba is and what it is used for 
 
Deltyba contains the active substance delamanid, an antibiotic for the treatment of tuberculosis in the lung 
caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis. 
 
 
2. What you need to know before you take Deltyba 
 
Do not take Deltyba: 
- if you are allergic to delamanid or any of the other ingredients of this medicine (listed in section 6). 
- if you have very low levels of albumin, in the blood. 
- if you are taking medicines that strongly induce a certain liver enzyme called “CYP450 3A4” (e.g. 
 carbamazepine). 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before taking Deltyba. 
Before you start taking Deltyba, and during the treatment, your doctor may check your heart’s electrical 
activity using an ECG (electrocardiogram) machine (electrical recording of the heart). Your doctor 
may also perform a blood test to check the concentration of some minerals and proteins which are important 
for the function of your heart. 
 
Tell your doctor if you have one of the following conditions: 
• you have reduced levels of albumin, potassium, magnesium or calcium in the blood 
• you have been told that you have heart problems, for example a slow heart rhythm (bradycardia) or 

have a history of heart attack (myocardial infarction) 
• if you have a condition called congenital long QT syndrome or have a serious heart disease or 

problems with heart rhythm. 
• you have liver disease or kidney disease. 
• you have HIV. 



23 

 
Children  
Deltyba is not suitable for children under age 18. 
 
Other medicines and Deltyba 
Tell your doctor... 
- if you are taking, have recently taken or might take any other medicines, including medicines or herbal 

remedies obtained without prescription,  
- if you are taking medicines to treat an abnormal heart rhythm (e.g. amiodarone, disopyramide, dofetilide, 

ibutilide, procainamide, quinidine, hydroquinidine, sotalol). 
- if you are taking medicines to treat psychoses (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, 

haloperidol, mesoridazine, pimozide, or thioridazine) or depression 
- if you are taking certain antimicrobial medicines (e.g. erythromycin, clarithromycin, moxifloxacin, 

sparfloxacin, bedaquiline, or pentamidine).  
- if you are taking triazole antifungal medicines (e.g. fluconazole, itraconazole, voriconazole). 
-  if you are taking certain medicines to treat allergic reactions (e.g. terfenadine, astemizole, mizolastine). 
-  if you are taking certain medicines to treat malaria (e.g. halofantrine, quinine, chloroquine, 

artesunate/amodiaquine, dihydroartemisinin/piperaquine) 
-  if you are taking any of the following: cisapride (used to treat stomach disorders), droperidol (used 

against vomiting and migraine), domperidone (used against nausea and vomiting), diphemanil (used to 
treat stomach disorders or excessive sweating), probucol (lowers the level of cholesterol in the 
bloodstream), levomethadyl or methadone (used for the treatment of opiate addiction), vinca alkaloids 
(anti-cancer medicines), or arsenic trioxide (used to treat certain types of leukaemia). 

-  if you are taking HIV-medicines containing lopinavir/ritonavir, or saquinavir. 
You may be more at risk for dangerous changes of the heart rhythm. 
 
Pregnancy and breast-feeding 
Deltyba may cause harm to an unborn baby. It is not usually recommended for use during pregnancy. 
It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to get 
pregnant. Your doctor will weigh up the benefits to you against the risks to your baby of taking Deltyba 
whilst you are pregnant. 
It is not known if delamanid passes into breast milk in humans. Breast-feeding is not recommended during 
treatment with Deltyba. 
 
Driving and using machines 
Deltyba is not expected to have an influence on your ability to drive and use machines. If you experience 
side effects that might affect your ability to concentrate and react, do not drive or use machines. 
 
Deltyba contains lactose monohydrate. 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before 
taking this medicinal product. 
 
 
3. How to take Deltyba 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure. 
 
The recommended dose is two 50 mg tablets taken twice a day (morning and evening) as advised by your 
doctor. The tablets should be taken during or just after a meal. Swallow the tablets with water. 
 
If you take more Deltyba than you should 
If you have taken more tablets than your prescribed dose, contact your doctor or your local hospital. 
Remember to take the pack with you so that it is clear what medicine you have taken. 
 
If you forget to take Deltyba 
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, just 



24 

skip the missed dose. 
 
Do not take a double dose to make up for a forgotten tablet. 
 
If you stop taking Deltyba  
DO NOT stop taking the tablets unless your doctor tells you to. Stopping too early could allow the bacteria 
to recover and to become resistant to delamanid. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The frequency of the side effects listed below is defined using the following definitions: 
Very common: may affect more than 1 in 10 people 
Common: may affect up to 1 in 10 people 
Uncommon: may affect up to 1 in 100 people 
 
Side effects very commonly reported in clinical studies with Deltyba were: 
• Sensations of irregular and/or forceful beating of the heart 
• Vomiting 
• Nausea 
• Diarrhoea 
• Stomach pain 
• Headache 
• A tingling, burning or pricking sensation or numbness of the skin (paresthesia) 
• Shaking (tremor) 
• Decreased appetite 
• Dizziness 
• Hearing a persistent sound in your ear when no sound exists (tinnitus) 
• Intense lack of energy 
• Joint or muscle pain 
• Difficulties with falling or staying asleep 
• Increase in immature red blood cells 
• Low blood potassium level 
• Increased blood uric acid level 
• Coughing up blood 
• Changes found in investigations (electrocardiogram, ECG) of the heart 
 
Side effects commonly reported in clinical studies with Deltyba were: 
• Anaemia 
• Increase of certain white blood cells (eosinophilia) 
• Increased blood tryglycerides  
• Psychotic disorder 
• Agitation 
• Anxiety 
• Depression 
• Restlessness 
• Nerve damage causing numbness or pain (burning) or tingling feeling in hands or feet 
• Drowsiness 
• Reduced sensation 
• Dry eye 
• Decreased tolerability of the eyes for bright light 



25 

• Ear pain 
• Increase of blood pressure (hypertension) 
• Decrease of blood pressure (hypotension) 
• Bruising 
• Hot flushes 
• Shortness of breath 
• Cough 
• Pain in the mouth or throat 
• Throat irritation 
• Dry throat 
• Runny nose 
• Chest pain 
• Gastritis 
• Constipation 
• Indigestion 
• Dermatitis 
• Hives 
• Itching 
• Papules (small skin elevations) 
• Rash 
• Acne 
• Increased sweating 
• A bone disease called osteochondrosis 
• Muscular weakness 
• Pain in bones 
• Flank pain 
• Pain in arms or legs 
• Blood in urine 
• Fever 
• Chest pain 
• Feeling unwell 
• Chest discomfort 
• Foot, leg or ankle swelling 
• Increased values for blood investigations for the hormone cortisol 
 
Side effects uncommonly reported in clinical studies with Deltyba were: 
• Shingles 
• Oral thrush 
• Yeast infection of the skin (tinea versicolor) 
• Low white blood cell count (leukopenia) 
• Low blood platelets count (thrombocytopaenia) 
• Dehydration 
• Low blood calcium level 
• High blood cholesterol level 
• Aggression 
• Paranoia 
• Panic attacks 
• Adjustment disorder with depressed mood 
• Neurosis 
• Feeling of emotional and mental discomfort 
• Mental aberration 
• Problems with sleeping 
• Increase of libido 
• Lethargy 



26 

• Balance disorder 
• Regional pain 
• Allergic conjunctivitis 
• Heart rhythm problems 
• Swallowing problems 
• Abnormal feeling in the mouth 
• Tenderness in the abdomen 
• Hair loss 
• Itchy or red skin including around the hair roots. 
• Urine retention 
• Painful urination 
• Increased need to urinate at night 
• Feeling hot 
• Abnormal values for blood investigations related to coagulation (prolonged APPT) 
• Abnormal blood values related to the function of the liver, biliary system or pancreas 
• Decreased values for blood investigations for the hormone cortisol 
• Increased blood pressure 
 
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 Deltyba 
 
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 or blister after “EXP:”. The 
expiry date refers to the last day of that month. 
 
Store in the original package in order to protect from moisture. 
 
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 Deltyba contains 
- One film-coated tablet contains 50 mg of the active substance delamanid. 
- The other ingredients are hypromellose phthalate, povidone, all-rac-α-tocopherol, microcrystalline 

cellulose, sodium starch glycolate, carmellose calcium, colloidal hydrated silica, magnesium stearate, 
lactose monohydrate, hypromellose, macrogol 8000, titanium dioxide, talc, iron oxide (E172). 
 

What Deltyba looks like and contents of the pack 
Deltyba 50 mg film-coated tablets are round, and yellow. 
 
Deltyba is supplied in packs of 48 film-coated tablets in aluminium/aluminium blisters. 
 
Marketing Authorisation Holder and Manufacturer 
 
Otsuka Novel Products GmbH  
Erika-Mann-Straße 21 
80636 München 
Germany 

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


27 

Tel: +49 (0)89 206020 500 
 
Manufacturer 
AndersonBrecon (UK) Ltd.  
Wye Valley Business Park  
Brecon Road 
Hay-on-Wye 
Hereford, HR3 5PG United Kingdom 
 
R-Pharm Germany GmbH 
Heinrich-Mack-Straße 35 
89257 Illertissen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
BE 
Otsuka Novel Products GmbH 
Tél/Tel: +49 (0)89 206020 500 

LT 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

BG 
Otsuka Novel Products GmbH 
Teл.: +49 (0)89 206020 500 

LU 
Otsuka Novel Products GmbH 
Tél/Tel: +49 (0)89 206020 500 

CZ 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

HU 
Otsuka Novel Products GmbH 
Tel.: +49 (0)89 206020 500 

DK 
Otsuka Novel Products GmbH 
Tlf: +49 (0)89 206020 500 

MT 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

DE 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

NL 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

EE 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

NO 
Otsuka Novel Products GmbH 
Tlf: +49 (0)89 206020 500 

EL 
Otsuka Novel Products GmbH 
Τηλ: +49 (0)89 206020 500 

AT 
Otsuka Novel Products GmbH  
Tel: +49 (0)89 206020 500 

ES 
Otsuka Pharmaceutical S.A. 
Tel: +34 93 208 10 20 

PL 
Otsuka Novel Products GmbH 
Tel.: +49 (0)89 206020 500 

FR 
Otsuka Pharmaceutical France SAS 
Tél. : +33 (0)1 47 08 00 00  

PT 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

HR 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

RO 
Ewopharma AG 
Tel.: +40 (0)21 260 13 44; +40 (0)21 260 14 07 



28 

IE 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

SI 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

IS 
Otsuka Novel Products GmbH 
Sími: +49 (0)89 206020 500 

SK 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

IT 
Otsuka Pharmaceutical Italy S.r.l. 
Tel: +39 (0)2 00632710 

FI 
Otsuka Novel Products GmbH 
Puh/Tel: +49 (0)89 206020 500 

CY 
Otsuka Novel Products GmbH 
Τηλ: +49 (0)89 206020 500 

SE 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

LV 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

UK 
Otsuka Novel Products GmbH 
Tel: +49 (0)89 206020 500 

 
This leaflet was last revised in <{MM/YYYY}>. 
 
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about 
this medicine. 
The European Medicines Agency will review new information on this medicine at least every year and this 
leaflet will be updated as necessary. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.  
 
 

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

	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
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION 
	A. LABELLING
	B. PACKAGE LEAFLET