Orbactiv

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ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Orbactiv 400 mg powder for concentrate for solution for infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin. 
 
After reconstitution, 1 ml of the solution contains 10 mg oritavancin. 
 
After dilution, 1 ml of the solution for infusion contains 1.2 mg oritavancin. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for concentrate for solution for infusion (powder for concentrate). 
 
White to off-white powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Orbactiv is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in 
adults (see sections 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 
 
Posology 
 
1,200 mg administered as a single dose by intravenous infusion over 3 hours. 
 
Special populations 
 
Elderly (≥ 65 years) 
No dosage adjustment is required for patients ≥ 65 years of age (see section 5.2).  
 
Renal impairment 
No dosage adjustment is needed in patients with mild or moderate renal impairment (see section 5.2). 
The pharmacokinetics of oritavancin in patients with severe renal impairment has not been evaluated.  
Oritavancin is not removed from blood by haemodialysis procedures. 
 
Hepatic impairment 
No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh 
Class B) (see section 5.2). The pharmacokinetics of oritavancin in patients with severe hepatic 
impairment (Child-Pugh Class C) has not been evaluated, however based on pharmacokinetic 
parameters, severe hepatic impairment is not expected to have an impact on oritavancin exposure. 
Therefore no dose adjustment is required, even if caution should be exercised when prescribing 
oritavancin to patients with severe hepatic impariment (Child-Pugh Class C). 



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Paediatric population 
The safety and efficacy of oritavancin in children and adolescents (<18 years) have not yet been 
established.  No data are available. 
 
Method of administration  
 
Intravenous use. 
Intravenous infusion over 3 hours (see section 6.6).  
 
For instructions on reconstitution and dilution of the medicinal product before administration, see 
section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
 
Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after 
oritavancin administration because the activated partial thromboplastin time (aPTT) test results may 
remain falsely elevated for up to 120 hours after oritavancin administration (see sections 4.4 and 4.5). 
 
4.4 Special warnings and precautions for use 
 
Hypersensitivity reactions 
 
Serious hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock have been 
reported with the use of oritavancin. If an acute hypersensitivity reaction occurs during oritavancin 
infusion, oritavancin should be discontinued immediately and appropriate supportive care should be 
instituted.  
 
No data are available on cross-reactivity between oritavancin and other glycopeptides, including 
vancomycin. Before using oritavancin it is important to inquire carefully about previous 
hypersensitivity reactions to glycopeptides (e.g. vancomycin, telavancin). Due to the possibility of 
cross-hypersensitivity, there should be careful monitoring of patients with any history of glycopeptide 
hypersensitivity during and after the infusion. 
 
Infusion related reactions 
 
Oritavancin is given via intravenous infusion over 3 hours to minimise the risk of infusion related 
reactions. Intravenous infusions of oritavancin can cause reactions that resemble “red man syndrome”, 
including flushing of the upper body, urticaria, pruritis and/or rash. Infusion-associated reactions 
characterized by chest pain, chest discomfort, chills, tremor, back pain, neck pain, dyspnoea, hypoxia, 
abdominal pain and fever have been observed with the use of oritavancin, including after the 
administration of more than one dose of oritavancin (1200mg) during a single course of therapy. If 
reactions do occur, stopping or slowing the infusion may result in cessation of these symptoms (see 
section 4.8). 
 
Need for additional antibacterial agents 
 
Oritavancin is active against Gram positive bacteria only (see section 5.1). In mixed infections where 
Gram negative and/or certain types of anaerobic bacteria are suspected, oritavancin should be co-
administered with appropriate antibacterial agent(s). 
 
Concomitant use of warfarin 



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Oritavancin has been shown to artificially prolong prothrombin time (PT) and international normalised 
ratio (INR) for up to 12 hours, making the monitoring of the anticoagulation effect of warfarin 
unreliable up to 12 hours after an oritavancin dose.  
 
Interference with assay for coagulation tests  
 
Oritavancin has been shown to interfere with certain laboratory coagulation tests (see sections 4.3 and 
4.5).  Oritavancin concentrations that are found in the blood of patients following administration of a 
single dose have been shown to artificially prolong: 

• aPTT for up to 120 hours,  
• PT and INR for up to 12 hours,  
• Activated Clotting Time (ACT) for up to 24 hours, 
• Silica Clot Time (SCT) for up to 18 hours, and 
• Dilute Russell’s Viper Venom Test (DRVVT) for up to 72 hours. 

 
These effects result from oritavancin binding to and preventing the action of the phospholipid reagents 
which activate coagulation in commonly used laboratory coagulation tests. For patients who require 
aPTT monitoring within 120 hours of oritavancin dosing, a non-phospholipid dependent coagulation 
test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT 
monitoring may be considered.  
 
The Chromogenic Factor Xa Assay, the Thrombin Time (TT) assay and the assays used for the 
diagnosis of Heparin Induced Thrombocytopenia (HIT) are not affected by oritavancin. In vitro, 
oritavancin 46.6 μg/mL did not affect an assay for activated protein C resistance (APCR), suggesting 
that there is a low likelihood that oritavancin will interfere with this test. However, APCR is a 
phospholipid-based test and it cannot be ruled out that higher concentrations of oritavancin that may 
occur during clinical use could interfere with this test. 
 
No effect of oritavancin on the in vivo coagulation system was observed in nonclinical and clinical 
studies. 
 
Clostridioides difficile-associated diarrhoea 
 
Antibacterial-associated colitis and pseudomembranous colitis have been reported for oritavancin 
and may range in severity from mild to life threatening diarrhoea. Therefore, it is important to 
consider this diagnosis in patients who present with diarrhoea subsequent to the administration of 
oritavancin (see section 4.8). In such a circumstance, the use of supportive measures together with the 
administration of specific treatment for Clostridioides difficile should be considered. 
 
Superinfection  
 
The use of antibacterial medicinal products may increase the risk of overgrowth of non-susceptible 
micro-organisms. If superinfection occurs, appropriate measures should be taken. 
 
Osteomyelitis 
 
In Phase 3 ABSSSI clinical trials, more cases of osteomyelitis were reported in the oritavancin-treated 
arm than in the vancomycin-treated arm (see section 4.8). Patients should be monitored for signs and 
symptoms of osteomyelitis after administration of oritavancin. If osteomyelitis is suspected or 
diagnosed, appropriate alternative antibacterial therapy should be instituted.  
 
Abscess 
 



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In the Phase 3 clinical trials, slightly more cases of newly emergent abscesses were reported in the 
oritavancin-treated arm than in the vancomycin-treated arm (4.6% vs 3.4%, respectively) (see section 
4.8). If newly emergent abscesses occur, appropriate measures should be taken.  
 
Limitations of the clinical data 
In the two major trials in ABSSSI the types of infections treated were confined to cellulitis, abscesses 
and wound infections only. Other types of infections have not been studied. There is limited 
experience in clinical studies in patients with bacteraemia, peripheral vascular disease or neutropenia, 
in immunocompromised patients, in patients aged > 65 years and in infections due to S. pyogenes.   
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Substances metabolised by cytochrome P450  
 
A screening drug-drug interaction study was conducted in healthy volunteers (n=16) evaluating the 
concomitant administration of a single 1,200 mg dose of oritavancin with probe substrates for several 
CYP450 enzymes. Oritavancin was found to be a nonspecific, weak inhibitor (CYP2C9 and 
CYP2C19) or a weak inducer (CYP3A4 and CYP2D6) of several CYP isoforms. 
 
Caution should be used when administering oritavancin concomitantly with medicinal products with a 
narrow therapeutic window that are predominantly metabolised by one of the affected CYP450 
enzymes(e.g., warfarin), as co-administration may increase (e.g., for CYP2C9 substrates) or decrease 
(e.g., for CYP2D6 substrates) concentrations of the narrow therapeutic range medicinal product. 
Patients should be closely monitored for signs of toxicity or lack of efficacy if they have been given 
oritavancin while on a potentially affected compound (e.g. patients should be monitored for bleeding, 
if concomitantly receiving oritavancin and warfarin) (see section 4.4). A study to assess the drug-drug 
interaction effect of a single 1,200mg dose of oritavancin on the pharmacokinetics of S-warfarin 
following a single dose was conducted in 36 healthy subjects. S-warfarin pharmacokinetics were 
evaluated following a single dose of warfarin 25 mg given alone, or administered at the start, 24, or 72 
hours after a single 1,200mg dose of oritavancin. The results showed no effect of oritavancin on S-
warfarin AUC and Cmax. 
 
Drug-laboratory test interactions (see sections 4.3 and 4.4) 
 
Oritavancin binds to and prevents the action of the phospholipid reagents which activate coagulation in 
commonly used laboratory coagulation tests. Oritavancin concentrations achieved in the blood after 
1,200 mg doses may produce falsely elevated results from certain laboratory tests (see Table 1). 
 
Table 1: Coagulation tests affected by oritavancin 

Assay Duration of interference 

Prothrombin time (PT) Up to 12 hours 
International normalized ratio (INR) Up to 12 hours 

Activated partial thromboplastin time (aPTT) Up to 120 hours 

Activated clotting time (ACT) Up to 24 hours 

Silica clot time (SCT)   Up to 18 hours 

Dilute Russell’s viper venom time (DRVVT) Up to 72 hours 
 
 
 
4.6 Fertility, pregnancy and lactation 
 



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Pregnancy 
 
There are no or limited amount of data from the use of oritavancin in pregnant women. Animal studies 
do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
As a precautionary measure, it is preferable to avoid the use of oritavancin during pregnancy unless the 
potential benefit justifies the potential risk to the foetus.  
 
Breast-feeding 
 
Available pharmacodynamic/toxicological data in animals have shown excretion of oritavancin in milk 
(see section 5.3). It is unknown whether oritavancin/metabolites are excreted in human milk. A risk to 
the newborns/infants cannot be excluded. 
 
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from 
oritavancin therapy taking into account the benefit of breast feeding for the child and the benefit of 
therapy for the woman. 
 
Fertility 
 
Animal studies have revealed no evidence of impaired fertility due to oritavancin at the highest 
concentrations administered, however, there is no data on the effects of oritavancin on human fertility. 
 
4.7 Effects on ability to drive and use machines 
 
Oritavancin has a minor influence on the ability to drive and use machines. Dizziness may occur and 
this may have an effect on driving and use of machines (see section 4.8). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
 
The most commonly reported adverse reactions (≥5%) were: nausea, hypersensitivity reactions, 
infusion site reactions, and headache. The most commonly reported serious adverse reaction was 
cellulitis (1.1%).  The most common reported reasons for discontinuation were cellulitis (0.4%) and 
osteomyelitis (0.3%). Female patients had a higher reporting rate for adverse reactions than male 
patients. 
 
Tabulated list of adverse reactions 
 
Adverse reactions for oritavancin from the pooled Phase 3 ABSSSI clinical trials with single dose 
oritavancin are listed by system organ class in the following table.   
 
Frequencies are defined as: 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); not known (cannot be estimated from 
the available data). Within each frequency grouping, undesirable effects are presented in order of 
decreasing seriousness. 
 
Table 2: Frequency of adverse reactions by system organ class 
System organ class Frequency Adverse Reactions 
Infections and infestations 
 Common Cellulitis, abscess (limb and subcutaneous) 
 Uncommon Osteomyelitis 
Blood and lymphatic system disorders 
 Common Anaemia  



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 Uncommon Eosinophilia, thrombocytopenia 
Immune system disorders 
 Uncommon Hypersensitivity (see sections 4.3 and 4.4) , 

anaphylactic reaction 
 Unknown Anaphylactic shock 
Metabolism and nutrition disorders 
 Uncommon Hypoglycaemia, hyperuricaemia 
Nervous system disorders 
 Common Headache, dizziness 
 Rare Tremor* 
Cardiac disorders 
 Common Tachycardia 
Respiratory, thoracic and mediastinal disorders 
 Uncommon Bronchospasm, wheezing, dyspnoea* 
 Rare Hypoxia* 
Gastrointestinal disorders 
 Common Nausea, vomiting, diarrhoea, constipation 
 Uncommon Abdominal pain* 
Hepatobiliary disorders 
 Common Liver function test abnormal (Alanine 

aminotransferase increased, Aspartate 
aminotransferase increased) 

 Uncommon Blood bilirubin increased 
Skin and subcutaneous tissue disorders 
 Common Urticaria, rash, pruritis 
 Uncommon Leucocytoclastic vasculitis, angioedema, 

erythema multiforme, flushing 
Musculoskeletal and connective tissue disorders 
 Common Myalgia 
 Uncommon Tenosynovitis 
 Rare Back pain*, neck pain* 
General disorders and administration site conditions 
 Common Infusion site reactions, including the following 

symptoms infusion site phlebitis, infusion site 
erythema, extravasation, induration, pruritis, 
rash, oedema peripheral 

 Uncommon Chest pain*, pyrexia* 
 Rare Red man syndrome, chest discomfort*, chills* 

*These reactions may be infusion-related (see section 4.4) 
 
 
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 
 
In the clinical programme of 3,017 oritavancin-treated subjects; there was no incidence of accidental 
overdose of oritavancin.  
 

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


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Oritavancin is not removed from blood by haemodialysis procedures. In the event of overdose, 
supportive measures should be taken. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antibacterials for systemic use, glycopeptide antibacterials, 
ATC code: J01XA05 
 
Mechanism of action 
 
Oritavancin has three mechanisms of action: (i) inhibition of the transglycosylation (polymerization) 
step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors; (ii) inhibition 
of the transpeptidation (crosslinking) step of cell wall biosynthesis by binding to the peptide bridging 
segments of the cell wall; and (iii) disruption of bacterial membrane integrity, leading to 
depolarization, permeabilization, and rapid cell death.   
 
Resistance 
 
Gram-negative organisms are intrinsically resistant to all glycopeptides, including oritavancin. 
 
Resistance to oritavancin was observed in vitro in vancomycin-resistant isolates of Staphylococcus 
aureus. There is no known cross-resistance between oritavancin and non-glycopeptide classes of 
antibiotics. 
 
Oritavancin exhibits reduced in vitro activity against certain Gram-positive organisms of the genera 
Lactobacillus, Leuconostoc and Pediococcus that are intrinsically resistant to glycopeptides.  
 
Susceptibility testing break points 
 
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on 
Antimicrobial Susceptibility Testing (EUCAST) are as follows:  
 
Table 3:  Susceptibility Interpretive Criteria for Oritavancin 

Organism group 
MIC breakpoints 

(mg/L) 
S ≤ R > 

Staphylococcus aureus  0.125 0.125 
Beta-haemolytic streptococci Groups A, B, C, G 0.25 0.25 
Viridans group streptococci (S. anginosus group 
only) 0.25 0.25 

S=Susceptible, R=Resistant 
 
Pharmacokinetic/Pharmacodynamic (PK/PD) relationship 
 
The area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC) ratio 
of oritavancin for the infecting organism has been shown to be the parameter that best correlates with 
efficacy. 
 
Clinical efficacy against specific pathogens 
 
Efficacy has been demonstrated in clinical studies against the following pathogens that were 
susceptible to oritavancin in vitro. 



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Gram-positive microorganisms: 
• Staphylococcus aureus  
• Streptococcus pyogenes 
• Streptococcus agalactiae 
• Streptococcus dysgalactiae 
• Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) 
 
 
Antibacterial activity against other relevant pathogens 
 
Clinical efficacy has not been established against the following pathogens although in vitro studies 
suggest that they would be susceptible to oritavancin in the absence of acquired mechanisms of 
resistance: 
•  Beta-haemolytic streptococci of Group G 
•  Clostridium perfringens 
•  Peptostreptococcus spp. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
oritavancin in one or more subsets of the paediatric population in the treatment of acute bacterial skin 
and skin structure infections (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Oritavancin exhibits linear pharmacokinetics at a dose up to 1,200 mg. The mean (CV%) maximum 
oritavancin concentration (Cmax) and AUC0-∞ in patients receiving a single 1,200 mg dose in ABSSSI 
patients is 138 (23) μg/ml and 2,800 (28.6) μg•h/mL respectively.   
 
Distribution 
 
Oritavancin is approximately 85% bound to human plasma proteins. Based on population PK analysis, 
the population mean total volume of distribution is estimated to be approximately 87.6 L, indicating 
oritavancin is extensively distributed into the tissues.   
 
Exposures (AUC0-24) of oritavancin in skin blister fluid were 20% of those in plasma after a single 
800 mg dose in healthy subjects. 
 
Biotransformation 
 
No metabolites were observed in plasma or bile from oritavancin treated dogs and rats, respectively. 
Additionally, in vitro human liver microsome studies indicated that oritavancin is not metabolized.  
 
Elimination 
 
No mass balance study has been conducted in humans. In humans, less than 1% to 5% of the dose was 
recovered as parent drug in faeces and urine respectively after 2 weeks of collection indicating that 
oritavancin is slowly excreted unchanged.  
 
The mean terminal elimination plasma half-life of oritavancin is 245 hours (14.9% CV) based on 
population PK analysis of ABSSSI patients receiving a single 1,200 mg dose. The population mean 
total clearance is estimated at 0.445 L/h (27.2 % CV). 
 



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In a population PK analysis, a relationship between height and clearance was identified, where 
clearance increased with increasing height. Dose modification based on height is not necessary. 
 
Special populations 
 
Renal impairment 
The pharmacokinetics of oritavancin was examined in the single dose Phase 3 ABSSSI studies in 
patients with normal renal function, CrCL ≥90 mL/min (n=213), mild renal impairment, 
CrCL 60-89 mL/min (n=59), moderate renal impairment, CrCL 30-59 mL/min (n=22), and severe 
renal impairment CrCL <30 mL/min (n=3). Population pharmacokinetic analysis indicated that renal 
impairment had no clinically relevant effect on the exposure of oritavancin. No dedicated studies in 
dialysis patients have been conducted. 
Dosage adjustment of oritavancin is not needed in patients with mild or moderate renal impairment. 
The pharmacokinetics of oritavancin in patients with severe renal impairment has not been evaluated.  
 
Hepatic impairment 
The pharmacokinetics of oritavancin were evaluated in a study of subjects with moderate hepatic 
impairment (Child-Pugh Class B, n=20) and compared with healthy subjects (n=20) matched for 
gender, age and weight. There were no relevant changes in pharmacokinetics of oritavancin in subjects 
with moderate hepatic impairment. 
 
Dosage adjustment of oritavancin is not needed in patients with mild and moderate hepatic 
impairment. The pharmacokinetics of oritavancin in patients with severe hepatic impairment has not 
been studied. 
 
Effects of age, weight, gender and race   
Population PK analysis from the single dose Phase 3 ABSSSI studies in patients indicated that gender, 
age, weight, or race had no clinically relevant effect on the exposure of oritavancin. No dosage 
adjustment is warranted in these subpopulations. 
 
5.3 Preclinical safety data 
 
The primary adverse effect of oritavancin administration to rats and dogs was a dose related 
accumulation of eosinophilic granules in tissue macrophages including hepatocytes, renal cortical 
epithelial cells, adrenal cells and macrophages of the reticulo endothelial system. The appearance of 
the eosinophilic granules did not occur following single dose administration and did not significantly 
affect innate macrophage function in vitro at intracellular levels anticipated from a single 1,200 mg 
dose. 
 
Moderate, dose-related increases in liver enzymes (alanine transaminase and aspartate transaminase) 
were observed in rats and dogs and were shown to be reversible upon cessation of treatment. 
Biochemistry changes associated with kidney function including decreases in urine-specific gravity 
and pH and slight increases in blood urea nitrogen and sporadic increases in creatinine were present in 
both rat and dog after treatment of two weeks. Extramedullary haematopoiesis in the spleen was 
observed in rats. This histopathological finding correlated with an enlargement and an increase in the 
weight of the spleen. The exposure in rats at the no observed adverse effect level (NOAEL) was less to 
only slightly higher than the human exposure based on the AUC. 
 
Histamine-like infusion reactions following immediately or shortly after dosing with oritavancin 
occurred in both rats and dogs. These reactions were associated with mortality at lower dosages in 
male than in female rats in single dose studies; however, the same gender-related differences were not 
observed in other species. Studies in neonatal rats and dogs for 30 days showed the same tissue effects 
as those seen in adult animals including sensitivity to the oritavancin-mediated histamine-like infusion 
reactions. Mortality was observed in neonatal rats at slightly lower dosage levels than in adults. 
 



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A standard battery of in vitro and in vivo tests on the genotoxic potential did not reveal any clinically 
relevant findings. Lifetime studies in animals have not been conducted to evaluate the carcinogenic 
potential of oritavancin.  
 
When administered intravenously at doses up to 30 mg/kg, oritavancin did not affect the fertility or 
reproductive performance of male and female rats. Studies in pregnant rats and rabbits do not indicate 
direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition 
or postnatal development. There was no evidence of transplacental transfer of oritavancin in pregnant 
rats. The exposure in rats at the NOAEL was less to only slightly higher than the human exposure 
based on the AUC. 
 
Following a single intravenous infusion in lactating rats, radio-labelled [14C]oritavancin was excreted in 
milk and absorbed by nursing pups. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Mannitol 
Phosphoric acid (for pH-adjustment) 
 
6.2 Incompatibilities 
 
Sodium chloride solution should not be used for dilution as it is incompatible with oritavancin and 
may cause precipitation of the medicinal product. Therefore, other substances, additives or other 
medicinal products mixed in sodium chloride solution for intravenous use should not be added to 
oritavancin single-use vials or infused simultaneously through the same intravenous line or through a 
common intravenous port. In addition, medicinal products formulated at a basic or neutral pH may be 
incompatible with oritavancin (see section 6.6). 
 
6.3 Shelf life 
 
4 years 
 
After reconstitution 
 
The reconstituted solution should be further diluted in glucose 50 mg/ml (5%) intravenous infusion 
bag immediately. 
 
After dilution 
 
The diluted solution should be used immediately.  
 
From a microbiological point of view, the product should be used immediately. If not used 
immediately storage times and conditions prior to use are the responsibility of the user and would 
normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C following dilution in a glucose 5% 
intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated 
aseptic conditions. 
 
6.4 Special precautions for storage 
 
Do not store above 25°C.  
 
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3. 



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6.5 Nature and contents of container  
 
Single-use 50 ml Type 1 glass vials with rubber stoppers and aluminium flip off cap. 
 
3 individual vials are packaged in a carton. 
 
6.6 Special precautions for disposal and other handling  
 
For single use only. Orbactiv should be prepared under aseptic techniques in a pharmacy. 
 
The powder must be reconstituted with water for injections and the resulting concentrate must be 
diluted in a glucose 5% intravenous infusion bag prior to use. Both the reconstituted solution and the 
diluted solution for infusion should be clear, colourless to pale yellow solution. Parenteral medicinal 
products should be inspected visually for particulate matter after reconstitution.  
Reconstitution:.   
• 40 mL of water for injections (WFI) should be added using a sterile syringe to reconstitute each 

vial to provide a 10 mg/mL solution per vial.  
• To avoid excessive foaming, it is recommended that WFI should be added carefully, along the 

walls of the vials. 
• Each vial should be swirled gently to avoid foaming and ensure that all of the powder is 

completely reconstituted in solution.  
 

Dilution: Three reconstituted vials are needed for dilution for administration of a single 1,200 mg 
intravenous infusion. Only glucose 5% intravenous bag (D5W) should be used for dilution. Sodium 
chloride solution should not be used for dilution (see section 6.2). 
 
Dilution: 
• Withdraw and discard 120 mL from a 1,000 mL D5W intravenous bag. 
• Withdraw 40 mL from each of the three reconstituted vials and add to D5W intravenous bag to 

bring the bag volume to 1,000 mL. This yields a concentration of 1.2 mg/mL of oritavancin. PP 
(Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration 
preparation.  

 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Menarini International Operations Luxembourg S.A.  
1, Avenue de la Gare  
L-1611, Luxembourg  
Luxembourg 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/989/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19/03/2015 
Date of latest renewal: 13/01/2020 



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10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
 
 
 
 
 
 
 

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


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ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

USE OF THE MEDICINAL PRODUCT 
 



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Biologici Italia Laboratories S.r.l 
Via Filippo Serpero 2 
20060 Masate (MI) 
Italy  
 
 
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. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 

• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 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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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



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A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Orbactiv 400 mg powder for concentrate for solution for infusion 
oritavancin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin. 
After reconstitution and dilution, 1 ml solution for infusion contains 1.2 mg oritavancin. 
 
 
3. LIST OF EXCIPIENTS 
 
Mannitol  
Phosphoric acid  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for concentrate for solution for infusion 
3 vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use.  
Intravenous use. 
For single use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



19 
 

Do not store above 25°C. 
 
 
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 
 
Menarini International O. L. S.A.  
1, Avenue de la Gare,  L-1611 Luxembourg  
Luxembourg 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/989/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 



20 
 

 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Orbactiv 400 mg powder for concentrate 
oritavancin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Contains 400 mg oritavancin. 
 
 
3. LIST OF EXCIPIENTS 
 
Mannitol  
Phosphoric acid  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for concentrate 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intravenous use. 
For single use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C.  
 



21 
 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Menarini International O. L. S.A.  
1, Avenue de la Gare, L-1611 Luxembourg  
Luxembourg 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/989/001  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 



22 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



23 
 

Package leaflet: Information for the patient 
 

Orbactiv 400 mg powder for concentrate for solution for infusion  
oritavancin 

 
 
Read all of this leaflet carefully before you are given this medicine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or nurse. 
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Orbactiv is and what it is used for  
2. What you need to know before you are given Orbactiv 
3. How you will be given Orbactiv  
4. Possible side effects  
5. How to store Orbactiv  
6. Contents of the pack and other information 
 
 
1. What Orbactiv is and what it is used for 
 
Orbactiv is an antibiotic that contains the active substance oritavancin. Oritavancin is a type of 
antibiotic (a lipoglycopeptide antibiotic) that can kill or stop the growth of certain bacteria. 
Orbactiv is used to treat infections of the skin and underlying tissues.  
It is for use in adults only. 
 
Orbactiv can only be used to treat infections caused by bacteria known as Gram positive bacteria. In 
mixed infections where other types of bacteria are suspected, your doctor will give you other 
appropriate antibiotics together with Orbactiv.    
 
 
2. What you need to know before you are given Orbactiv  
 
You must not be given Orbactiv  
- if you are allergic to oritavancin or any of the other ingredients of this medicine (listed in 

section 6). 
- if it is expected that you may need to be given a blood thinning medicine (unfractionated 

heparin sodium)  within 5 days (120 hours) of the dose of Orbactiv. 
 
Warnings and precautions  
Talk to your doctor or nurse before receiving Orbactiv if you: 
• have ever had an allergic reaction to another glycopeptide antibiotic (such as vancomycin and 

telavancin)  
• have developed severe diarrhoea during or following antibiotic treatment in the past.  
• have or are suspected to have a bone infection caused by bacteria (osteomyelitis). Your doctor 

will treat you as necessary 
• have or are suspected to have a painful collection of pus on your skin (abscess). Your doctor 

will treat you as necessary. 
 
Intravenous infusions of Orbactiv can cause flushing of the upper body, hives, itching and/or rashes. 
Infusion-associated reactions characterized by chest pain, chest discomfort, chills, tremor, back pain, 
neck pain, shortness of breath, abdominal pain, fever and headache, fatigue, somnolence that might be 



24 
 

symptoms of hypoxia, have also been observed. If you experience these types of reactions, your doctor 
may decide to stop or slow the infusion. 
 
Orbactiv may interfere with laboratory tests that measure how well your blood is clotting and may 
cause a false reading.  
 
While antibiotics, including Orbactiv, fight certain bacteria, they may not be active against other 
bacteria or fungi, which may, therefore, continue to grow. This is called overgrowth. Your doctor will 
monitor you in case this happens and treat you if necessary. 
 
After being given Orbactiv, you may get a new infection at another site on your skin. Your doctor 
should monitor you in case this happens and treat you as necessary. 
 
Children and adolescents 
Orbactiv should not to be used in children or adolescents below the age of 18. 
 
Other medicines and Orbactiv 
Tell your doctor if you are using, have recently used or might use any other medicines.  
 
If you are going to be given a blood thinner called unfractionated heparin, then tell your doctor if you 
have received Orbactiv within the last 5 days (120 hours).  
 
It is particularly important to tell your doctor if you are using medicines that prevent blood from 
clotting (oral anticoagulants, e.g.coumarin anticoagulants ). Orbactiv may interfere with laboratory 
tests or self-test that measure how well your blood is clotting (INR) and may cause a false reading up 
to 12 hours after the infusion. 
 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before you are given this medicine. 
 
You should not be given this medicine during pregancy unless the benefit is considered to be greater 
than the risk to the baby. 
 
Driving and using machines 
Orbactiv may cause dizziness, which can influence your ability to drive or operate machines. 
 
 
3. How you will be given Orbactiv 
 
Orbactiv will be given to you by your doctor or nurse, by infusion (drip) into a vein. 
 
The recommended dose for Orbactiv is one single infusion of 1,200 mg administered into a vein over 
3 hours. 
 
If you are given more Orbactiv than you should 
Your doctor will decide how to treat you, including stopping the treatment and monitoring for signs of 
ill effects.  
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 



25 
 

Tell your doctor or nurse immediately if you experience a reaction to the infusion including any 
of the following symptoms: 
• Flushing of the face and upper body, hives, itching and/or rashes (red man syndrome)   
• Wheezing;  
• Shortness of breath;  
• Swelling around throat or under the skin that develops over a short period of time;  
• Shivering or trembling;  
• Rapid or weak pulse;  
• Chest pain or tightness;  
• Decrease in blood pressure (which could make you feel faint or dizzy).  
 
Such reactions may be life-threatening.  
 
Other side effects occur with the following frequencies: 
 
Common side effects (may affect up to 1 in 10 patients): 
• Fewer red blood cells or less haemoglobin than normal; 
• Feeling dizzy; 
• Headache; 
• Feeling sick (nausea) or being sick (vomiting); 
• Diarrhoea; 
• Constipation; 
• Pain or irritation where the injection was given;  
• Itching, skin rash; 
• Muscle pain; 
• More enzymes produced by your liver (as shown in blood tests); 
• Heart racing or beating fast; 
• Infection getting worse or new infection at another site on your skin; 
• Swollen, red area of skin or underneath skin that feels hot and tender;  
• Accumulation of pus underneath the skin. 
 
Uncommon side effects (may affect up to 1 in 100 patients): 
• Higher than normal levels of eosinophils, a type of white blood cell (eosinophilia); 
• Low blood sugar; 
• High uric acid levels in the blood; 
• Increased blood bilirubin levels ; 
• Severe rash; 
• Flushing; 
• Inflammation surrounding a tendon (known as tenosynovitis); 
• Bone infection caused by bacteria (known as osteomyelitis); 
• Reduced blood platelet count below the normal lower limit (known as thrombocytopenia); 
• Abdominal pain 
• Chest pain 
• Fever 
• Shortness of breath 
 
Rare side effects(may affect up to 1 in 1000 patients): 
• Headache, fatigue, somnolence that might be symptoms of hypoxia; 
• Back pain 
• Neck pain 
• Chills 
• Tremor. 
 
 
Reporting of side effects 



26 
 

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Orbactiv 
 
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 label. The expiry date refers to the 
last day of that month. 
Do not store above 25°C.  
 
Do not throw away any medicines via wastewater. 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 Orbactiv contains  
- The active substance is oritavancin. Each vial contains oritavancin diphosphate equivalent to 

400 mg oritavancin. 
- The other ingredients are mannitol and phosphoric acid. 
 
What Orbactiv looks like and contents of the pack 
- Orbactiv is a powder for concentrate for solution for infusion 
- Orbactiv is a white to off white powder, supplied in a 50 ml glass vial.  
- Orbactiv is available in cartons containing 3 vials.  
 
Marketing Authorisation Holder 
 
Menarini International Operations Luxembourg S.A.  
1, Avenue de la Gare  
L-1611, Luxembourg  
Luxembourg 
 
Manufacturer 
 
Biologici Italia Laboratories S.r.l 
Via Filippo Serpero 2 
20060 Masate (MI) 
Italy  
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Menarini Benelux NV/SA 
Tél/Tel: + 32 (0)2 721 4545 
 

Lietuva 
UAB “BERLIN-CHEMIE MENARINI 
BALTIC” 
Tel: +370 52 691 947 
 

България Luxembourg/Luxemburg 

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


27 
 

Берлин-Хеми/А. Менарини България EООД 
тел.: +359 24540950 

Menarini Benelux NV/SA 
Tél/Tel: + 32 (0)2 721 4545 
 

Česká republika 
Berlin-Chemie/A.Menarini Ceska republika s.r.o. 
Tel: +420 267 199 333 
 

Magyarország 
Berlin-Chemie/A. Menarini Kft. 
Tel.: +36 23501301 

Danmark 
Menarini International Operations Luxembourg 
S.A. 
Tlf: +352 264976 

Malta 
Menarini International Operations Luxembourg 
S.A. 
Tel: +352 264976 
 

Deutschland 
Berlin-Chemie AG 
Tel: +49 (0) 30 67070 

Nederland 
Menarini Benelux NV/SA 
Tel: +32 (0)2 721 4545 
 
 

Eesti 
OÜ Berlin-Chemie Menarini Eesti 
Tel: +372 667 5001 

Norge 
Menarini International Operations Luxembourg 
S.A. 
Tlf: +352 264976 
 
 
 

Ελλάδα 
MENARINI HELLAS AE 
Τηλ: +30 210 8316111-13 

Österreich 
A. Menarini Pharma GmbH 
Tel: +43 1 879 95 85-0 
 

España 
Laboratorios Menarini S.A. 
Tel: +34-93 462 88 00 

Polska 
Berlin-Chemie/Menarini Polska Sp. z o.o. 
Tel.: +48 22 566 21 00 
 

France 
MENARINI France 
Tél: +33 (0)1 45 60 77 20 

Portugal 
A. Menarini Portugal – Farmacêutica, S.A. 
Tel: +351 210 935 500 
 

Hrvatska 
Berlin-Chemie Menarini Hrvatska d.o.o. 
Tel: + 385 1 4821 361 
 

România 
Berlin-Chemie A.Menarini S.R.L. 
Tel: +40 21 232 34 32 
 

Ireland 
A. Menarini Pharmaceuticals Ireland Ltd 
Tel: +353 1 284 6744 

Slovenija 
Berlin-Chemie / A. Menarini Distribution 
Ljubljana d.o.o.  
Tel: +386 01 300 2160 
 

Ísland 
Menarini International Operations Luxembourg 
S.A. 
Sími: +352 264976  
 

Slovenská republika 
Berlin-Chemie / A. Menarini Distribution 
Slovakia s.r.o  
Tel: +421 2 544 30 730 

Italia 
A. Menarini - Industrie Farmaceutiche Riunite - 
s.r.l. 
Tel: +39-055 56801 
 

Suomi/Finland 
Berlin-Chemie/A.Menarini Suomi OY 
Puh/Tel: +358 403 000 760 
 



28 
 

Κύπρος 
MENARINI HELLAS AE 
Τηλ: +30 210 8316111-13 

Sverige 
Menarini International Operations Luxembourg 
S.A. 
Tel: +352 264976 
 

Latvija 
SIA Berlin-Chemie/Menarini Baltic 
Tel: +371 67103210 

United Kingdom 
A. Menarini Farmaceutica Internazionale S.R.L. 
Tel: +44 (0)1628 856400 

 
This leaflet was last revised in:  
 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
 
---------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
Orbactiv is intended for intravenous (IV) administration, only after reconstitution and dilution. 
Three Orbactiv 400 mg vials need to be reconstituted and diluted to prepare a single once-only 1,200 
mg IV dose. 
Orbactiv should be prepared under aseptic techniques in a pharmacy. 
 
The powder must be reconstituted with water for injections and the resulting concentrate must be 
diluted in a glucose 5% intravenous infusion bag prior to use. Both the reconstituted solution and the 
diluted solution for infusion should be clear, colourless to pale yellow solution. Parenteral medicinal 
products should be inspected visually for particulate matter after reconstitution. Aseptic procedures 
should be used for the preparation of Orbactiv.  
 
Reconstitution: Aseptic technique should be used to reconstitute three Orbactiv 400 mg vials. 
• 40 mL of water for injections (WFI) should be added using a sterile syringe to reconstitute each 

vial to provide a 10 mg/mL solution per vial.  
• To avoid excessive foaming, it is recommended that WFI should be added carefully, along the 

walls of the vials. 
• Each vial should be swirled gently to avoid foaming and ensure that all Orbactiv powder is 

completely reconstituted in solution.  
 

The reconstituted solution should be further diluted in glucose 5% intravenous infusion bag 
immediately. 
 
Dilution: Three reconstituted vials are needed for dilution for administration of a single 1,200 mg IV 
infusion. Only glucose 5% intravenous bag (D5W) should be used for dilution.  
  
To dilute: 
• Withdraw and discard 120 mL from a 1,000 mL D5W intravenous bag.   
• Withdraw 40 mL from each of the three reconstituted vials and add to D5W intravenous bag to 

bring the bag volume to 1,000 mL. This yields a concentration of 1.2 mg/mL of oritavancin. PP 
(Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration 
preparation. 
 

The diluted solution should be used immediately.  



29 
 

 
From a microbiological point of view, the product should be used immediately. If not used 
immediately storage times and conditions prior to use are the responsibility of the user and would 
normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C for Orbactiv diluted in glucose 5% 
intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated 
aseptic conditions.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



30 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annex IV 

Scientific conclusions and grounds for the variation to the terms of the marketing 
authorisation(s) 

 
 
 
 
 

 



31 
 

Scientific conclusions 

Taking into account the PRAC Assessment Report on the PSUR(s) for oritavancin, the scientific 
conclusions of CHMP are as follows:  

In view of available data on infusion related reactions from clinical trial(s), and spontaneous reports 
and considering that reported cases have a close temporal relationship, a positive de-challenge and in 
some cases positive re-challenge and in view of a plausible mechanism of action, the PRAC 
considers a causal relationship between oritavancin and chest pain/discomfort, chills, back pain, 
dyspnoea, fever, tremor, hypoxia, neck pain and abdominal pain are at least a reasonable possibility. 
The PRAC concluded that the product information of product containing oritavancin should be 
amended accordingly. 

The CHMP agrees with the scientific conclusions made by the PRAC. 

 

Grounds for the variation to the terms of the marketing authorisation(s) 

On the basis of the scientific conclusions for oritavancin the CHMP is of the opinion that the 
benefit-risk balance of the medicinal product(s) containing oritavancin is unchanged subject to the 
proposed changes to the product information 

The CHMP recommends that the terms of the marketing authorisation(s) should be varied. 

 
 
 
 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
	Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)