Vectibix

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Vectibix 20 mg/mL concentrate for solution for infusion. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each mL of concentrate contains 20 mg panitumumab. 
 
Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL. 
 
When prepared according to the instructions given in section 6.6, the final panitumumab concentration 
should not exceed 10 mg/mL. 
 
Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) 
by recombinant DNA technology. 
 
Excipient with known effect 
Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Concentrate for solution for infusion (sterile concentrate). 
 
Colourless, pH 5.6 to 6.0 solution that may contain translucent to white, visible amorphous, 
proteinaceous panitumumab particles. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal 
cancer (mCRC): 
 in first-line in combination with FOLFOX or FOLFIRI. 
 in second-line in combination with FOLFIRI for patients who have received first-line 

fluoropyrimidine-based chemotherapy (excluding irinotecan). 
 as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing 

chemotherapy regimens. 
 
4.2 Posology and method of administration 
 
Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy. 
Evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with 
Vectibix. Mutational status should be determined by an experienced laboratory using validated test 
methods for detection of KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4) mutations. 
 



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Posology 
 
The recommended dose of Vectibix is 6 mg/kg of bodyweight given once every two weeks. 
 
Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological 
reactions as follows: 
 

Occurrence of 
skin symptom(s):  

≥ grade 31 

Administration 
of Vectibix 

Outcome Dose regulation 

Initial occurrence Withhold 1 or 
2 doses 

Improved (< grade 3) Continuing infusion 
at 100% of original dose

Not recovered Discontinue 
At the second 

occurrence 
Withhold 1 or 

2 doses 
Improved (< grade 3) Continuing infusion at 80% 

of original dose
Not recovered Discontinue 

At the third 
occurrence 

Withhold 1 or 
2 doses 

Improved (< grade 3) Continuing infusion at 60% 
of original dose

Not recovered Discontinue 
At the fourth 
occurrence 

Discontinue - - 

1 Greater than or equal to grade 3 is defined as severe or life-threatening 
 
Special populations 
 
The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment. 
 
There is no clinical data to support dose adjustments in the elderly. 
 
Paediatric population 
 
There is no relevant use of Vectibix in the paediatric population in the indication treatment of 
colorectal cancer. 
 
Method of administration 
 
Vectibix must be administered as an intravenous infusion via an infusion pump. 
 
Prior to infusion, Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection 
to a final concentration not to exceed 10 mg/mL (for preparation instructions see section 6.6). 
 
Vectibix must be administered using a low protein binding 0.2 or 0.22 micrometre in-line filter, 
through a peripheral line or indwelling catheter. The recommended infusion time is approximately 
60 minutes. If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 
60 minutes. Doses higher than 1,000 mg should be infused over approximately 90 minutes (for 
handling instructions, see section 6.6). 
 
The infusion line should be flushed with sodium chloride solution before and after Vectibix 
administration to avoid mixing with other medicinal products or intravenous solutions. 
 
A reduction in the rate of infusion of Vectibix may be necessary in cases of infusion-related reactions 
(see section 4.4). 
 
Vectibix must not be administered as an intravenous push or bolus. 
 
For instructions on dilution of the medicinal product before administration, see section 6.6. 



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4.3 Contraindications 
 
Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of 
the excipients listed in section 6.1 (see section 4.4). 
 
Patients with interstitial pneumonitis or pulmonary fibrosis (see section 4.4). 
 
The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients 
with mutant RAS mCRC or for whom RAS mCRC status is unknown (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Dermatologic reactions and soft tissue toxicity 
 
Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor 
receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 94%) treated with 
Vectibix. Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening 
(NCI-CTC grade 4) skin reactions in < 1% of patients who received Vectibix monotherapy and in 
combination with chemotherapy (n = 2,224) (see section 4.8). If a patient develops dermatologic 
reactions that are grade 3 (CTCAE v 4.0) or higher, or that are considered intolerable, see the 
recommendation for dose modification in section 4.2. 
 
In clinical studies, subsequent to the development of severe dermatologic reactions (including 
stomatitis), infectious complications including sepsis and necrotising fasciitis, in rare cases leading to 
death, and local abscesses requiring incisions and drainage were reported. Patients who have severe 
dermatologic reactions or soft tissue toxicity or who develop worsening reactions whilst receiving 
Vectibix should be monitored for the development of inflammatory or infectious sequelae (including 
cellulitis and necrotising fasciitis), and appropriate treatment promptly initiated. Life-threatening and 
fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients 
treated with Vectibix. Rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have 
been reported in patients treated with Vectibix in the post-marketing setting. Withhold or discontinue 
Vectibix in the event of dermatologic or soft tissue toxicity associated with severe or life-threatening 
inflammatory or infectious complications. 
 
Treatment and management of dermatologic reactions should be based on severity and may include a 
moisturiser, sun screen (SPF > 15 UVA and UVB), and topical steroid cream (not stronger than 1% 
hydrocortisone) applied to affected areas, and/or oral antibiotics (e.g. doxycycline). It is also 
recommended that patients experiencing rash/dermatological toxicities wear sunscreen and hats and 
limit sun exposure as sunlight can exacerbate any skin reactions that may occur. Patients may be 
advised to apply moisturiser and sunscreen to face, hands, feet, neck, back and chest every morning 
during treatment, and to apply the topical steroid to face, hands, feet, neck, back and chest every night 
during treatment. 
 
Pulmonary complications 
 
Patients with a history of, or evidence of, interstitial pneumonitis or pulmonary fibrosis were excluded 
from clinical studies. Cases of interstitial lung disease (ILD), both fatal and non-fatal, have been 
reported, mainly from the Japanese population. In the event of acute onset or worsening pulmonary 
symptoms, Vectibix treatment should be interrupted and a prompt investigation of these symptoms 
should occur. If ILD is diagnosed, Vectibix should be permanently discontinued and the patient should 
be treated appropriately. In patients with a history of interstitial pneumonitis or pulmonary fibrosis, the 



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benefits of therapy with panitumumab versus the risk of pulmonary complications must be carefully 
considered. 
 
Electrolyte disturbances 
 
Progressively decreasing serum magnesium levels leading to severe (grade 4) hypomagnesaemia have 
been observed in some patients. Patients should be periodically monitored for hypomagnesaemia and 
accompanying hypocalcaemia prior to initiating Vectibix treatment, and periodically thereafter for up 
to 8 weeks after the completion of treatment (see section 4.8). Magnesium repletion is recommended, 
as appropriate. 
 
Other electrolyte disturbances, including hypokalaemia, have also been observed. Monitoring as above 
and repletion as appropriate of these electrolytes is also recommended. 
 
Infusion-related reactions 
 
Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions 
(occurring within 24 hours of an infusion) were reported in Vectibix-treated patients, including severe 
infusion-related reactions (NCI-CTC grade 3 and grade 4). 
 
In the post-marketing setting, serious infusion-related reactions have been reported, including rare 
post-marketing reports with a fatal outcome. If a severe or life-threatening reaction occurs during an 
infusion or at any time post-infusion [e.g. presence of bronchospasm, angioedema, hypotension, need 
for parenteral treatment, or anaphylaxis], Vectibix should be permanently discontinued (see 
sections 4.3 and 4.8). 
 
In patients experiencing a mild or moderate (CTCAE v 4.0 grades 1 and 2) infusion-related reaction 
the infusion rate should be reduced for the duration of that infusion. It is recommended to maintain 
this lower infusion rate in all subsequent infusions. 
 
Hypersensitivity reactions occurring more than 24 hours after infusion have been reported including a 
fatal case of angioedema that occurred more than 24 hours after the infusion. Patients should be 
informed of the possibility of a late onset reaction and instructed to contact their physician if 
symptoms of a hypersensitivity reaction occur. 
 
Acute renal failure 
 
Acute renal failure has been observed in patients who develop severe diarrhoea and dehydration. 
Patients who experience severe diarrhoea should be instructed to consult a healthcare professional 
urgently. 
 
Vectibix in combination with irinotecan, bolus 5-fluorouracil, and leucovorin (IFL) chemotherapy 
 
Patients receiving Vectibix in combination with the IFL regimen [bolus 5-fluorouracil (500 mg/m2), 
leucovorin (20 mg/m2) and irinotecan (125 mg/m2)] experienced a high incidence of severe diarrhoea 
(see section 4.8). Therefore administration of Vectibix in combination with IFL should be avoided (see 
section 4.5). 
 
Vectibix in combination with bevacizumab and chemotherapy regimens 
 
Shortened progression-free survival time and increased deaths were observed in the patients receiving 
Vectibix in combination with bevacizumab and chemotherapy. A greater frequency of pulmonary 
embolism, infections (predominantly of dermatologic origin), diarrhoea, electrolyte imbalances, 
nausea, vomiting and dehydration was also observed in the treatment arms using Vectibix in 
combination with bevacizumab and chemotherapy. Vectibix should not be administered in 
combination with bevacizumab containing chemotherapy (see sections 4.5 and 5.1). 
 



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Vectibix in combination with oxaliplatin-based chemotherapy in patients with mutant RAS mCRC or 
for whom RAS tumour status is unknown 
 
The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients 
with mutant RAS mCRC or for whom RAS mCRC status is unknown (see sections 4.3 and 5.1). 
 
A shortened progression-free survival (PFS) and overall survival (OS) time were observed in patients 
with mutant KRAS (exon 2) tumours and additional RAS mutations (KRAS [exons 3 and 4] or NRAS 
[exons 2, 3, 4]) who received panitumumab in combination with infusional 5-fluorouracil, leucovorin, 
and oxaliplatin (FOLFOX) versus FOLFOX alone (see section 5.1). 
 
RAS mutational status should be determined using a validated test method by an experienced 
laboratory (see section 4.2). If Vectibix is to be used in combination with FOLFOX then it is 
recommended that mutational status be determined by a laboratory that participates in a RAS External 
Quality Assurance programme or wild-type status be confirmed in a duplicate test. 
 
Ocular toxicities 
 
Serious cases of keratitis and ulcerative keratitis have been rarely reported in the post-marketing 
setting. Patients presenting with signs and symptoms suggestive of keratitis such as acute or 
worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye 
should be referred promptly to an ophthalmology specialist. 
 
If a diagnosis of ulcerative keratitis is confirmed, treatment with Vectibix should be interrupted or 
discontinued. If keratitis is diagnosed, the benefits and risks of continuing treatment should be 
carefully considered. 
 
Vectibix should be used with caution in patients with a history of keratitis, ulcerative keratitis or 
severe dry eye. Contact lens use is also a risk factor for keratitis and ulceration. 
 
Patients with ECOG 2 performance status treated with Vectibix in combination with chemotherapy 
 
For patients with ECOG 2 performance status, assessment of benefit-risk is recommended prior to 
initiation of Vectibix in combination with chemotherapy for treatment of mCRC. A positive benefit-
risk balance has not been documented in patients with ECOG 2 performance status. 
 
Elderly patients 
 
No overall differences in safety or efficacy were observed in elderly patients (≥ 65 years of age) 
treated with Vectibix monotherapy. However, an increased number of serious adverse reactions were 
reported in elderly patients treated with Vectibix in combination with FOLFIRI or FOLFOX 
chemotherapy compared to chemotherapy alone (see section 4.8). 
 
Warnings for excipients 
 
This medicinal product contains 3.45 mg sodium per mL, equivalent to 0.017% of the WHO 
recommended maximum daily intake of 2 g sodium for an adult. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Data from an interaction study involving Vectibix and irinotecan in patients with mCRC indicated that 
the pharmacokinetics of irinotecan and its active metabolite, SN-38, are not altered when the 
medicinal products are co-administered. Results from a cross-study comparison indicated that 
irinotecan-containing regimens (IFL or FOLFIRI) have no effect on the pharmacokinetics of 
panitumumab. 
 



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Vectibix should not be administered in combination with IFL chemotherapy or with bevacizumab-
containing chemotherapy. A high incidence of severe diarrhoea was observed when panitumumab was 
administered in combination with IFL (see section 4.4), and increased toxicity and deaths were seen 
when panitumumab was combined with bevacizumab and chemotherapy (see sections 4.4 and 5.1). 
 
The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients 
with mutant RAS mCRC or for whom RAS mCRC status is unknown. A shortened progression-free 
survival and overall survival time were observed in a clinical study in patients with mutant RAS 
tumours who received panitumumab and FOLFOX (see sections 4.4 and 5.1). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no adequate data from the use of Vectibix in pregnant women. Studies in animals have 
shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. EGFR has 
been implicated in the control of prenatal development and may be essential for normal organogenesis, 
proliferation, and differentiation in the developing embryo. Therefore, Vectibix has the potential to 
cause foetal harm when administered to pregnant women. 
 
Human IgG is known to cross the placental barrier, and panitumumab may therefore be transmitted 
from the mother to the developing foetus. In women of childbearing potential, appropriate 
contraceptive measures must be used during treatment with Vectibix, and for 2 months following the 
last dose. If Vectibix is used during pregnancy or if the patient becomes pregnant while receiving this 
medicinal product, she should be advised of the potential risk for loss of the pregnancy or potential 
hazard to the foetus. 
 
Breast-feeding 
 
It is unknown whether panitumumab is excreted in human breast milk. Because human IgG is secreted 
into human milk, panitumumab might also be secreted. The potential for absorption and harm to the 
infant after ingestion is unknown. It is recommended that women do not breast-feed during treatment 
with Vectibix and for 2 months after the last dose. 
 
Fertility 
 
Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in 
monkeys (see section 5.3). Panitumumab may impact the ability of a woman to become pregnant. 
 
4.7 Effects on ability to drive and use machines 
 
Vectibix may have a minor influence on the ability to drive and use machines. If patients experience 
treatment-related symptoms affecting their vision and/or ability to concentrate and react, it is 
recommended that they do not drive or use machines until the effect subsides. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in 
combination with chemotherapy (n = 2,224), the most commonly reported adverse reactions are skin 
reactions occurring in approximately 94% of patients. These reactions are related to the pharmacologic 
effects of Vectibix, and the majority are mild to moderate in nature with 23% severe (grade 3 
NCI-CTC) and < 1% life-threatening (grade 4 NCI-CTC). For clinical management of skin reactions, 
including dose modification recommendations, see section 4.4. 
 



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Very commonly reported adverse reactions occurring in ≥ 20% of patients were gastrointestinal 
disorders [diarrhoea (46%), nausea (39%), vomiting (26%), constipation (23%) and abdominal pain 
(23%)]; general disorders [fatigue (35%), pyrexia (21%)]; metabolism and nutrition disorders 
[decreased appetite (30%)]; infections and infestations [paronychia (20%)]; and skin and subcutaneous 
disorders [rash (47%), dermatitis acneiform (39%), pruritus (36%), erythema (33%) and dry skin 
(21%)]. 
 
Tabulated list of adverse reactions 
 
The data in the table below describe adverse reactions reported from clinical studies in patients with 
mCRC who received panitumumab as a single agent or in combination with chemotherapy (n = 2,224) 
and spontaneous reporting. Within each frequency grouping, undesirable effects are presented in order 
of decreasing seriousness. 
 

 Adverse reactions 

MedDRA system 
organ class 

Very common  
(≥ 1/10) 

Common  
(≥ 1/100 to < 1/10) 

Uncommon 
(≥ 1/1,000 to 

< 1/100) 
Infections and 
infestations 

Conjunctivitis 
Paronychia1 

Rash pustular 
Cellulitis1 
Urinary tract infection 
Folliculitis 
Localised infection

Eye infection 
Eyelid infection 

Blood and lymphatic 
system disorders 

Anaemia Leucopenia  

Immune system 
disorders 

 Hypersensitivity1 Anaphylactic 
reaction2 

Metabolism and 
nutrition disorders 

Hypokalaemia 
Hypomagnesaemia 
Decreased appetite 

Hypocalcaemia 
Dehydration 
Hyperglycaemia 
Hypophosphataemia

 

Psychiatric disorders Insomnia Anxiety  
Nervous system 
disorders 

 Headache 
Dizziness

 

Eye disorders  Blepharitis 
Growth of eyelashes 
Lacrimation increased 
Ocular hyperaemia 
Dry eye 
Eye pruritus 
Eye irritation

Ulcerative keratitis1,4 
Keratitis1 
Eyelid irritation 

Cardiac disorders Tachycardia Cyanosis  
Vascular disorders  Deep vein thrombosis 

Hypotension 
Hypertension 
Flushing

 

Respiratory, thoracic 
and mediastinal 
disorders 

Dyspnoea 
Cough 

Pulmonary embolism 
Epistaxis 

Interstitial lung 
disease3 
Bronchospasm 
Nasal dryness 

Gastrointestinal 
disorders 

Diarrhoea1 
Nausea 
Vomiting 
Abdominal pain 
Stomatitis 
Constipation 

Rectal haemorrhage 
Dry mouth 
Dyspepsia 
Aphthous ulcer 
Cheilitis 
Gastro-oesophageal reflux 
disease

Chapped lips 
Dry lips 



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 Adverse reactions 

MedDRA system 
organ class 

Very common  
(≥ 1/10) 

Common  
(≥ 1/100 to < 1/10) 

Uncommon 
(≥ 1/1,000 to 

< 1/100) 
Skin and subcutaneous 
tissue disorders1 

Dermatitis acneiform 
Rash 
Erythema 
Pruritus 
Dry skin 
Skin fissures 
Acne 
Alopecia 

Skin ulcer 
Skin exfoliation 
Exfoliative rash 
Dermatitis 
Rash papular 
Rash pruritic 
Rash erythematous 
Rash generalised 
Rash macular 
Rash maculo-papular 
Skin lesion 
Skin toxicity 
Scab 
Hypertrichosis 
Onychoclasis 
Nail disorder 
Hyperhidrosis 
Palmar-plantar 
erythrodysaesthesia syndrome 

Toxic epidermal 
necrolysis4 
Stevens-Johnson 
syndrome4 
Skin necrosis4 
Angioedema1 
Hirsutism 
Ingrowing nail 
Onycholysis 

Musculoskeletal and 
connective tissue 
disorders 

Back pain Pain in extremity  

General disorders and 
administration site 
conditions 

Fatigue 
Pyrexia 
Asthenia 
Mucosal inflammation 
Oedema peripheral 

Chest pain 
Pain 
Chills 

 

Injury, poisoning and 
procedural 
complications 

  Infusion-related 
reaction1 

Investigations Weight decreased Blood magnesium decreased  
1 See section “Description of selected adverse reactions” below 
2 See section 4.4 Infusion-related reactions 
3 See section 4.4 Pulmonary complications 
4 Ulcerative keratitis, skin necrosis, Stevens-Johnson syndrome and toxic epidermal necrolysis are panitumumab ADRs that 
were reported in the post-marketing setting. For these ADRs the maximum frequency category was estimated from the upper 
limit of 95% confidence interval for the point estimate based on regulatory guidelines for estimation of the frequency of 
adverse reactions from spontaneous reporting. The maximum frequency estimated from the upper limit of 95% confidence 
interval for the point estimate, i.e., 3/2,224 (or 0.13%). 
 
The safety profile of Vectibix in combination with chemotherapy consisted of the reported adverse 
reactions of Vectibix (as a monotherapy) and the toxicities of the background chemotherapy regimen. 
No new toxicities or worsening of previously recognised toxicities beyond the expected additive 
effects were observed. Skin reactions were the most frequently occurring adverse reactions in patients 
receiving panitumumab in combination with chemotherapy. Other toxicities that were observed with a 
greater frequency relative to monotherapy included hypomagnesaemia, diarrhoea, and stomatitis. 
These toxicities infrequently led to discontinuation of Vectibix or of chemotherapy. 
 
Description of selected adverse reactions 
 
Gastrointestinal disorders 
 
Diarrhoea when reported was mainly mild or moderate in severity. Severe diarrhoea (NCI-CTC 
grade 3 and 4) was reported in 2% of patients treated with Vectibix as a monotherapy and in 16% of 
patients treated with Vectibix in combination with chemotherapy. 
 



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There have been reports of acute renal failure in patients who develop diarrhoea and dehydration (see 
section 4.4). 
 
Infusion-related reactions 
 
Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions 
(occurring within 24 hours of any infusion), which may include symptoms/signs such as chills, fever 
or dyspnoea, were reported in approximately 5% of Vectibix-treated patients, of which 1% were 
severe (NCI-CTC grade 3 and grade 4). 
 
A case of fatal angioedema occurred in a patient with recurrent and metastatic squamous cell 
carcinoma of the head and neck treated with Vectibix in a clinical trial. The fatal event occurred after 
re-exposure following a prior episode of angioedema; both episodes occurred greater than 24 hours 
after administration (see sections 4.3 and 4.4). Hypersensitivity reactions occurring more than 
24 hours after infusion have also been reported in the post-marketing setting. 
 
For clinical management of infusion-related reactions, see section 4.4. 
 
Skin and subcutaneous tissue disorders 
 
Skin rash most commonly occurred on the face, upper chest, and back, but could extend to the 
extremities. Subsequent to the development of severe skin and subcutaneous reactions, infectious 
complications including sepsis, in rare cases leading to death, cellulitis and local abscesses requiring 
incisions and drainage were reported. The median time to first symptom of dermatologic reaction was 
10 days, and the median time to resolution after the last dose of Vectibix was 31 days. 
 
Paronychial inflammation was associated with swelling of the lateral nail folds of the toes and fingers. 
 
Dermatological reactions (including nail effects), observed in patients treated with Vectibix or other 
EGFR inhibitors, are known to be associated with the pharmacologic effects of therapy. 
 
Across all clinical trials, skin reactions occurred in approximately 94% of patients receiving Vectibix 
as monotherapy or in combination with chemotherapy (n = 2,224). These events consisted 
predominantly of rash and dermatitis acneiform and were mostly mild to moderate in severity. Severe 
(NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin 
reactions in < 1% of patients. Life-threatening and fatal infectious complications including necrotising 
fasciitis and sepsis have been observed in patients treated with Vectibix (see section 4.4). 
 
For clinical management of dermatological reactions, including dose modification recommendations, 
see section 4.4. 
 
In the post-marketing setting, rare cases of skin necrosis, Stevens-Johnson syndrome and toxic 
epidermal necrolysis (see section 4.4) have been reported. 
 
Ocular toxicities 
 
Non-serious cases of keratitis have been observed in 0.3% of clinical trial patients. In the 
post-marketing setting, serious cases of keratitis and ulcerative keratitis have been rarely reported (see 
section 4.4). 
 
Other special populations 
 
No overall differences in safety or efficacy were observed in elderly patients (≥ 65 years of age) 
treated with Vectibix monotherapy. However, an increased number of serious adverse events were 
reported in elderly patients treated with Vectibix in combination with FOLFIRI (45% versus 32%) or 
FOLFOX (52% versus 37%) chemotherapy compared to chemotherapy alone (see section 4.4). The 
most increased serious adverse events included diarrhoea in patients treated with Vectibix in 



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combination with either FOLFOX or FOLFIRI, and dehydration and pulmonary embolism when 
patients were treated with Vectibix in combination with FOLFIRI. 
 
The safety of Vectibix has not been studied in patients with renal or hepatic impairment. 
 
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 
 
Doses up to 9 mg/kg have been tested in clinical trials. There have been reports of overdose at doses 
up to approximately twice the recommended therapeutic dose (12 mg/kg). Adverse events observed 
included skin toxicity, diarrhoea, dehydration and fatigue and were consistent with the safety profile at 
the recommended dose. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC08 
 
Mechanism of action 
 
Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity 
and specificity to the human EGFR. EGFR is a transmembrane glycoprotein that is a member of a 
subfamily of type I receptor tyrosine kinases including EGFR (HER1/c-ErbB-1), HER2, HER3, and 
HER4. EGFR promotes cell growth in normal epithelial tissues, including the skin and hair follicle, 
and is expressed on a variety of tumour cells. 
 
Panitumumab binds to the ligand binding domain of EGFR and inhibits receptor autophosphorylation 
induced by all known EGFR ligands. Binding of panitumumab to EGFR results in internalisation of 
the receptor, inhibition of cell growth, induction of apoptosis, and decreased interleukin 8 and vascular 
endothelial growth factor production. 
 
KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) and NRAS (Neuroblastoma RAS viral 
oncogene homologue) are highly related members of the RAS oncogene family. KRAS and NRAS 
genes encode small, GTP-binding proteins involved in signal transduction. A variety of stimuli, 
including that from the EGFR activate KRAS and NRAS which in turn stimulate other intracellular 
proteins to promote cell proliferation, cell survival and angiogenesis. 
 
Activating mutations in the RAS genes occur frequently in a variety of human tumours and have been 
implicated in both oncogenesis and tumour progression. 
 
Pharmacodynamic effects 
 
In vitro assays and in vivo animal studies have shown that panitumumab inhibits the growth and 
survival of tumour cells expressing EGFR. No anti-tumour effects of panitumumab were observed in 
human tumour xenografts lacking EGFR expression. The addition of panitumumab to radiation, 
chemotherapy or other targeted therapeutic agents, in animal studies resulted in an increase in anti-
tumour effects compared to radiation, chemotherapy or targeted therapeutic agents alone. 
 



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Dermatological reactions (including nail effects), observed in patients treated with Vectibix or other 
EGFR inhibitors, are known to be associated with the pharmacologic effects of therapy (with cross-
reference to sections 4.2 and 4.8). 
 
Immunogenicity 
 
As with all therapeutic proteins, there is potential for immunogenicity. Data on the development of 
anti-panitumumab antibodies has been evaluated using two different screening immunoassays for the 
detection of binding anti-panitumumab antibodies (an ELISA which detects high-affinity antibodies, 
and a Biosensor Immunoassay which detects both high and low-affinity antibodies). For patients 
whose sera tested positive in either screening immunoassay, an in vitro biological assay was 
performed to detect neutralising antibodies. 
 
As monotherapy: 
 The incidence of binding antibodies (excluding predose and transient positive patients) was 

< 1% as detected by the acid-dissociation ELISA and 3.8% as detected by the Biacore assay; 
 The incidence of neutralising antibodies (excluding predose and transient positive patients) 

was < 1%; 
 Compared with patients who did not develop antibodies, no relationship between the presence 

of anti-panitumumab antibodies and pharmacokinetics, efficacy and safety has been observed. 
In combination with irinotecan- or oxaliplatin-based chemotherapy: 
 The incidence of binding antibodies (excluding predose positive patients) was 1% as detected 

by the acid-dissociation ELISA and < 1% as detected by the Biacore assay; 
 The incidence of neutralising antibodies (excluding predose positive patients) was < 1%; 
 No evidence of an altered safety profile was found in patients who tested positive for antibodies 

to Vectibix. 
 
The detection of antibody formation is dependent on the sensitivity and specificity of the assay. The 
observed incidence of antibody positivity in an assay may be influenced by several factors including 
assay methodology, sample handling, timing of sample collection, concomitant medicinal products 
and underlying disease, therefore, comparison of the incidence of antibodies to other products may be 
misleading. 
 
Clinical efficacy as monotherapy 
 
The efficacy of Vectibix as monotherapy in patients with metastatic colorectal cancer (mCRC) who 
had disease progression during or after prior chemotherapy was studied in open-label, single-arm trials 
(585 patients) and in two randomised controlled trials versus best supportive care (463 patients) and 
versus cetuximab (1,010 patients). 
 
A multinational, randomised, controlled trial was conducted in 463 patients with EGFR-expressing 
metastatic carcinoma of the colon or rectum after confirmed failure of oxaliplatin and irinotecan-
containing regimens. Patients were randomised 1:1 to receive Vectibix at a dose of 6 mg/kg given 
once every two weeks plus best supportive care (not including chemotherapy) (BSC) or BSC alone. 
Patients were treated until disease progression or unacceptable toxicity occurred. Upon disease 
progression BSC alone patients were eligible to crossover to a companion study and receive Vectibix 
at a dose of 6 mg/kg given once every two weeks. 
 
The primary endpoint was PFS. The study was retrospectively analysed by wild-type KRAS (exon 2) 
status versus mutant KRAS (exon 2) status. Tumour samples obtained from the primary resection of 
colorectal cancer were analysed for the presence of the seven most common activating mutations in 
the codon 12 and 13 of the KRAS gene. 427 (92%) patients were evaluable for KRAS status of which 
184 had mutations. The efficacy results from an analysis adjusting for potential bias from unscheduled 
assessments are shown in the table below. There was no difference in overall survival (OS) seen in 
either group. 
 



13 

 Wild-type KRAS (exon 2) 
population

Mutant KRAS (exon 2) 
population 

 Vectibix plus 
BSC 

(n = 124)

BSC 
(n = 119) 

Vectibix plus 
BSC 

(n = 84) 

BSC 
(n = 100) 

ORR n (%) 17% 0% 0% 0%
Response rate (investigator 
assessed)a (95% CI) 

22% 
(14, 32)

0% 
(0, 4) 

Stable Disease 34% 12% 12% 8%
PFS 
Hazard ratio (95% CI) 0.49 (0.37,0.65), p < 0.0001 1.07 (0.77,1.48), p = 0.6880
Median (weeks) 16.0 8.0 8.0 8.0
CI = confidence interval 
a In patients that crossed over to panitumumab after progression on BSC alone (95% CI) 
 
In an exploratory analysis of banked tumour specimens from this study, 11 of 72 patients (15%) with 
wild-type RAS tumours receiving panitumumab had an objective response compared to only 1 of 
95 patients (1%) with mutant RAS tumour status. Moreover, panitumumab treatment was associated 
with improved PFS compared to BSC in patients with wild-type RAS tumours (HR = 0.38 
[95% CI: 0.27, 0.56]), but not in patients with tumours harbouring a RAS mutation (HR = 0.98 
[95% CI: 0.73, 1.31]). 
 
The efficacy of Vectibix was also evaluated in an open-label trial in patients with wild-type KRAS 
(exon 2) mCRC. A total of 1,010 patients refractory to chemotherapy were randomised 1:1 to receive 
Vectibix or cetuximab to test whether Vectibix is non-inferior to cetuximab. The primary endpoint 
was OS. Secondary endpoints included PFS and objective response rate (ORR). 
 
The efficacy results for the study are presented in the table below. 
 

Wild-type KRAS (exon 2) 
population 

Vectibix 
(n = 499) 

Cetuximab 
(n = 500) 

OS 
Median (months) (95% CI) 10.4 (9.4, 11.6) 10.0 (9.3, 11.0) 
Hazard ratio (95% CI) 0.97 (0.84, 1.11) 
PFS 
Median (months) (95% CI) 4.1 (3.2, 4.8) 4.4 (3.2, 4.8) 
Hazard ratio (95% CI) 1.00 (0.88, 1.14) 
ORR 
n (%) (95% CI) 22% (18%, 26%) 20% (16%, 24%) 
Odds ratio (95% CI) 1.15 (0.83, 1.58) 
 
Overall, the safety profile of panitumumab was similar to that of cetuximab, in particular regarding 
skin toxicity. However, infusion reactions were more frequent with cetuximab (13% versus 3%) but 
electrolyte disturbances were more frequent with panitumumab, especially hypomagnesaemia 
(29% versus 19%). 
 
Clinical efficacy in combination with chemotherapy 
 
Among patients with wild-type RAS mCRC, PFS, OS, and ORR were improved for subjects receiving 
panitumumab plus chemotherapy (FOLFOX or FOLFIRI) compared with those receiving 
chemotherapy alone. Patients with additional RAS mutations beyond KRAS exon 2 were unlikely to 
benefit from the addition of panitumumab to FOLFIRI and a detrimental effect was seen with the 
addition of panitumumab to FOLFOX in these patients. BRAF mutations in exon 15 were found to be 
prognostic of worse outcome. BRAF mutations were not predictive of the outcome for panitumumab 
treatment in combination with FOLFOX or FOLFIRI. 



14 

 
First-line combination with FOLFOX 
 
The efficacy of Vectibix in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin 
(FOLFOX) was evaluated in a randomised, controlled trial of 1,183 patients with mCRC with the 
primary endpoint of PFS. Other key endpoints included the OS, ORR, time to response, time to 
progression (TTP), and duration of response. The study was prospectively analysed by tumour KRAS 
(exon 2) status which was evaluable in 93% of the patients. 
 
A predefined retrospective subset analysis of 641 patients of the 656 patients with wild-type KRAS 
(exon 2) mCRC was performed. Patient tumour samples with wild-type KRAS exon 2 (codons 12/13) 
status were tested for additional RAS mutations in KRAS exon 3 (codons 61) and exon 4 
(codons 117/146) and NRAS exon 2 (codons 12/13), exon 3 (codon 61), and exon 4 (codons 117/146) 
and BRAF exon 15 (codon 600). The incidence of these additional RAS mutations in the wild-type 
KRAS exon 2 population was approximately 16%. 
 
Results in patients with wild-type RAS mCRC and mutant RAS mCRC are presented in the table 
below. 
 
 Vectibix plus 

FOLFOX 
(months) 

Median (95% CI) 

FOLFOX  
(months) 

Median (95% CI) 

Difference 
(months) 

Hazard ratio  
(95% CI) 

Wild-type RAS population 
PFS 10.1 

(9.3, 12.0) 
7.9 

(7.2, 9.3)
2.2 0.72 

(0.58, 0.90)
OS 26.0 

(21.7, 30.4) 
20.2 

(17.7, 23.1)
5.8 0.78 

(0.62, 0.99)
Mutant RAS population 
PFS 7.3 

(6.3, 7.9) 
8.7 

(7.6, 9.4)
-1.4 1.31 

(1.07, 1.60)
OS 15.6 

(13.4, 17.9) 
19.2 

(16.7, 21.8)
-3.6 1.25 

(1.02, 1.55)
 
Additional mutations in KRAS and NRAS at exon 3 (codon 59) were subsequently identified (n = 7). 
An exploratory analysis showed similar results to those in the previous table. 
 
Combination with FOLFIRI 
 
The efficacy of Vectibix in second-line in combination with irinotecan, 5-fluorouracil (5-FU) and 
leucovorin (FOLFIRI) was evaluated in a randomised, controlled trial of 1,186 patients with mCRC 
with the primary endpoints of OS and PFS. Other key endpoints included the ORR, time to response, 
TTP, and duration of response. The study was prospectively analysed by tumour KRAS (exon 2) status 
which was evaluable in 91% of the patients. 
 
A predefined retrospective subset analysis of 586 patients of the 597 patients with wild-type KRAS 
(exon 2) mCRC was performed, where tumour samples from these patients were tested for additional 
RAS and BRAF mutations as previously described. The RAS/BRAF ascertainment was 85% (1,014 of 
1,186 randomised patients). The incidence of these additional RAS mutations (KRAS exons 3, 4 and 
NRAS exons 2, 3, 4) in the wild-type KRAS (exon 2) population was approximately 19%. The 
incidence of BRAF exon 15 mutation in the wild-type KRAS (exon 2) population was 
approximately 8%. Efficacy results in patients with wild-type RAS mCRC and mutant RAS mCRC are 
shown in the below table. 
 



15 

 Vectibix plus 
FOLFIRI 
(months) 

Median (95% CI) 

FOLFIRI  
(months) 

Median (95% CI) 

Hazard ratio  
(95% CI) 

Wild-type RAS population 
PFS 6.4 

(5.5, 7.4)
4.6 

(3.7, 5.6)
0.70 

(0.54, 0.91)
OS 16.2 

(14.5, 19.7)
13.9 

(11.9, 16.0)
0.81 

(0.63, 1.02)
Mutant RAS population 
PFS 4.8 

(3.7, 5.5)
4.0 

(3.6, 5.5)
0.86 

(0.70, 1.05)
OS 11.8 

(10.4, 13.1)
11.1 

(10.2, 12.4)
0.91 

(0.76, 1.10)
 
The efficacy of Vectibix in first-line in combination with FOLFIRI was evaluated in a single-arm 
study of 154 patients with the primary endpoint of objective response rate (ORR). Other key endpoints 
included the PFS, time to response, TTP, and duration of response. 
 
A predefined retrospective subset analysis of 143 patients of the 154 patients with wild-type KRAS 
(exon 2) mCRC was performed, where tumour samples from these patients were tested for additional 
RAS mutations. The incidence of these additional RAS mutations (KRAS exons 3, 4 and NRAS exons 2, 
3, 4) in the wild-type KRAS (exon 2) population was approximately 10%. 
 
Results in patients with wild-type RAS mCRC and mutant RAS mCRC from the primary analysis are 
presented in the table below. 
 
 Panitumumab + FOLFIRI 
 Wild-type RAS (n = 69) Mutant RAS (n = 74) 
ORR (%) 
(95% CI) 

59 
(46, 71)

41 
(30, 53) 

Median PFS (months) 
(95% CI)  

11.2 
(7.6, 14.8)

7.3 
(5.8, 7.5) 

Median Duration of response (months) 
(95% CI) 

13.0 
(9.3, 15.7)

5.8 
(3.9, 7.8) 

Median TTP (months) 
(95% CI) 

13.2 
(7.8, 17.0)

7.3 
(6.1, 7.6) 

 
First-line combination with bevacizumab and oxaliplatin or irinotecan-based chemotherapy 
 
In a randomised, open-label, controlled clinical trial, chemotherapy (oxaliplatin or irinotecan) and 
bevacizumab were given with and without panitumumab in the first-line treatment of patients with 
metastatic colorectal cancer (n = 1,053 [n = 823 oxaliplatin cohort, n = 230 irinotecan cohort]). 
Panitumumab treatment was discontinued due to a statistically significant reduction in PFS in patients 
receiving panitumumab observed in an interim analysis. 
 
The major study objective was comparison of PFS in the oxaliplatin cohort. In the final analysis, the 
hazard ratio for PFS was 1.27 (95% CI: 1.06, 1.52). Median PFS was 10.0 (95% CI: 8.9, 11.0) and 
11.4 (95% CI: 10.5, 11.9) months in the panitumumab and the non-panitumumab arm, respectively. 
There was an increase in mortality in the panitumumab arm. The hazard ratio for overall survival 
was 1.43 (95% CI: 1.11, 1.83). Median overall survival was 19.4 (95% CI: 18.4, 20.8) and 24.5 
(95% CI: 20.4, 24.5) in the panitumumab arm and the non-panitumumab arm. 
 
An additional analysis of efficacy data by KRAS (exon 2) status did not identify a subset of patients 
who benefited from panitumumab in combination with oxaliplatin- or irinotecan based chemotherapy 
and bevacizumab. For the wild-type KRAS subset of the oxaliplatin cohort, the hazard ratio for PFS 



16 

was 1.36 with 95% CI: 1.04-1.77. For the mutant KRAS subset, the hazard ratio for PFS was 1.25 with 
95% CI: 0.91-1.71. A trend for OS favouring the control arm was observed in the wild-type KRAS 
subset of the oxaliplatin cohort (hazard ratio = 1.89; 95% CI: 1.30, 2.75). A trend towards worse 
survival was also observed with panitumumab in the irinotecan cohort regardless of KRAS mutational 
status. Overall, panitumumab treatment combined with chemotherapy and bevacizumab is associated 
with an unfavourable benefit-to-risk profile irrespective of tumour KRAS mutational status. 
 
Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Vectibix in all subsets of the paediatric population in colorectal cancer (see section 4.2 for information 
on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Vectibix administered as a single agent or in combination with chemotherapy exhibits nonlinear 
pharmacokinetics. 
 
Following a single-dose administration of panitumumab as a 1-hour infusion, the area under the 
concentration-time curve (AUC) increased in a greater than dose-proportional manner and clearance 
(CL) of panitumumab decreased from 30.6 to 4.6 mL/day/kg as the dose increased from 0.75 to 
9 mg/kg. However, at doses above 2 mg/kg, the AUC of panitumumab increases in an approximately 
dose-proportional manner. 
 
Following the recommended dose regimen (6 mg/kg given once every 2 weeks as a 1-hour infusion), 
panitumumab concentrations reached steady-state levels by the third infusion with mean (± Standard 
Deviation [SD]) peak and trough concentrations of 213 ± 59 and 39 ± 14 mcg/mL, respectively. The 
mean (± SD) AUC0-tau and CL were 1,306 ± 374 mcg•day/mL and 4.9 ± 1.4 mL/kg/day, respectively. 
The elimination half-life was approximately 7.5 days (range: 3.6 to 10.9 days). 
 
A population pharmacokinetic analysis was performed to explore the potential effects of selected 
covariates on panitumumab pharmacokinetics. Results suggest that age (21-88), gender, race, hepatic 
function, renal function, chemotherapeutic agents, and EGFR membrane staining intensity (1+, 2+, 
3+) in tumour cells had no apparent impact on the pharmacokinetics of panitumumab. 
 
No clinical studies have been conducted to examine the pharmacokinetics of panitumumab in patients 
with renal or hepatic impairment. 
 
5.3 Preclinical safety data 
 
Adverse reactions seen in animals at exposure levels similar to clinical exposure levels and with 
possible relevance to clinical use were as follows: 
 
Skin rash and diarrhoea were the major findings observed in repeat-dose toxicity studies of up to 
26 weeks duration in cynomolgus monkeys. These findings were observed at doses approximately 
equivalent to the recommended human dose and were reversible upon termination of administration of 
panitumumab. The skin rash and diarrhoea observed in monkeys are considered related to the 
pharmacological action of panitumumab and are consistent with the toxicities observed with other 
anti-EGFR inhibitors. 
 
Studies to evaluate the mutagenic and carcinogenic potential of panitumumab have not been 
performed. 
 
Animal studies are insufficient with respect to embryo-foetal development since foetal panitumumab 
exposure levels were not examined. Panitumumab has been shown to cause foetal abortions and/or 
foetal deaths in cynomolgus monkeys when administered during the period of organogenesis at doses 
approximately equivalent to the recommended human dose. 



17 

 
Formal male fertility studies have not been conducted; however, microscopic evaluation of male 
reproductive organs from repeat-dose toxicity studies in cynomolgus monkeys at doses up to 
approximately 5-fold the human dose on a mg/kg basis, revealed no differences compared to control 
male monkeys. Fertility studies conducted in female cynomolgus monkeys showed that panitumumab 
may produce prolonged menstrual cycle and/or amenorrhea and reduced pregnancy rate which 
occurred at all doses evaluated. 
 
No pre- and post-natal development animal studies have been conducted with panitumumab. All 
patients should be advised regarding the potential risk of panitumumab on pre- and post-natal 
development prior to initiation of Vectibix therapy. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Sodium acetate trihydrate 
Acetic acid, glacial (for pH-adjustment) 
Water for injections. 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
6.3 Shelf life 
 
Vial 
 
3 years. 
 
Diluted solution 
 
Vectibix does not contain any antimicrobial preservative or bacteriostatic agent. The product should be 
used immediately after dilution. If not used immediately, in-use storage times and conditions prior to 
use are the responsibility of the user and should be no longer than 24 hours at 2°C – 8°C. The diluted 
solution must not be frozen. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Store in the original carton in order to protect from light. 
 
For storage conditions after dilution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
Type I glass vial with an elastomeric stopper, aluminium seal and flip-off plastic cap. 
One vial contains either 100 mg of panitumumab in 5 mL, or 400 mg panitumumab in 20 mL of 
concentrate for solution for infusion. 
 
Pack of 1 vial. 
 



18 

6.6 Special precautions for disposal and other handling 
 
Vectibix is intended for single use only. Vectibix should be diluted in sodium chloride 9 mg/mL 
(0.9%) solution for injection by healthcare professional using aseptic technique. Do not shake or 
vigorously agitate the vial. Vectibix should be inspected visually prior to administration. The solution 
should be colourless and may contain visible translucent-to-white, amorphous, proteinaceous 
particulates (which will be removed by in-line filtration). Do not administer Vectibix if its appearance 
is not as described above. Using only a 21-gauge or smaller diameter hypodermic needle, withdraw 
the necessary amount of Vectibix for a dose of 6 mg/kg. Do not use needle-free devices (e.g. vial 
adapters) to withdraw vial contents. Dilute in a total volume of 100 mL. The final concentration 
should not exceed 10 mg/mL. Doses higher than 1,000 mg should be diluted in 150 mL sodium 
chloride 9 mg/mL (0.9%) solution for injection (see section 4.2). The diluted solution should be mixed 
by gentle inversion, do not shake. 
 
No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) 
solution for injection in polyvinyl chloride bags or polyolefin bags. 
 
Discard the vial and any liquid remaining in the vial after the single-use. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/423/001 
EU/1/07/423/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 3 December 2007 
Date of latest renewal: 15 January 2015 
 
 
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/ 



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURERS 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 

 



20 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Immunex Rhode Island Corporation (ARI) 
40 Technology Way 
West Greenwich, 
Rhode Island 
02817 
USA 
 
Name and address of the manufacturers responsible for batch release 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Amgen Technology (Ireland) Unlimited Company 
Pottery Road 
Dun Laoghaire 
Co Dublin 
Ireland 
 
Amgen NV 
Telecomlaan 5-7 
1831 Diegem 
Belgium 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to 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 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. 
 
 



21 

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. 

 
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted 
at the same time. 
 



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



24 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vectibix 20 mg/mL concentrate for solution for infusion 
panitumumab 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 100 mg of panitumumab. 
Each vial contains 400 mg of panitumumab. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), water for injections. See leaflet for 
further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
5 mL of concentrate for solution for infusion. 
20 mL of concentrate for solution for infusion. 
 
x1 vial 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. 
Read the package leaflet before 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 
 
Do not shake. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



25 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061, 
4817 ZK Breda, 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/423/001 
EU/1/07/423/003 
 
 
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 



26 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Vectibix 20 mg/ml sterile concentrate 
panitumumab 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
100 mg/5 ml 
400 mg/20 ml 
 
 
6. OTHER 
 
Amgen Europe B.V. 
 
 



27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



28 

Package Leaflet: Information for the user 
 

Vectibix 20 mg/mL concentrate for solution for infusion 
panitumumab 

 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor. 
 If you get any side effects talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 
 
 
What is in this leaflet 
 
1. What Vectibix is and what it is used for 
2. What you need to know before you use Vectibix 
3. How to use Vectibix 
4. Possible side effects 
5. How to store Vectibix 
6. Contents of the pack and other information 
 
 
1. What Vectibix is and what it is used for 
 
Vectibix is used in the treatment of metastatic colorectal cancer (cancer of the bowel) for adult patients 
with a certain type of tumour known as a “Wild-type RAS tumour”. Vectibix is used alone or in 
combination with other anti-cancer medicines. 
 
Vectibix contains the active substance panitumumab, which belongs to a group of medicines called 
monoclonal antibodies. Monoclonal antibodies are proteins, which specifically recognise and attach 
(bind) to other unique proteins in the body. 
 
Panitumumab recognises and binds specifically to a protein known as epidermal growth factor 
receptor (EGFR), which is found on the surface of some cancer cells. When growth factors (other 
body proteins) attach to the EGFR, the cancer cell is stimulated to grow and divide. Panitumumab 
binds onto the EGFR and prevents the cancer cell from receiving the messages it needs for growth and 
division. 
 
 
2. What you need to know before you use Vectibix 
 
Do not use Vectibix: 
 
 if you are allergic to panitumumab or any of the other ingredients of this medicine (listed in 

section 6). 
 if you have previously had or have evidence of interstitial pneumonitis (swelling of the lungs 

causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the 
lungs with shortness of breath). 

 in combination with oxaliplatin-based chemotherapy, if your RAS test shows that you have 
mutant RAS tumour, or if your RAS tumour status is unknown. Please consult your doctor if you 
are unsure of your RAS tumour status. 

 



29 

Warnings and precautions 
 
You may experience skin reactions or severe swelling and tissue damage, if these worsen or become 
intolerable please tell your doctor or nurse immediately. If you experience a severe skin reaction, your 
doctor may recommend an adjustment of the dose of Vectibix. If you develop a severe infection or 
fever as a result of skin reactions, your doctor may stop your treatment with Vectibix. 
 
It is recommended that you limit sun exposure whilst receiving Vectibix and if you are experiencing 
skin reactions as sunlight can worsen these. Wear sunscreen and a hat if you are going to be exposed 
to sunlight. Your doctor may ask you to use a moisturiser, sun screen (SPF > 15), topical steroid, 
and/or oral antibiotics which may help in the management of skin toxicities that can be associated with 
the use of Vectibix. 
 
Your doctor will check your blood levels of several substances such as magnesium, calcium and 
potassium in your blood before you start Vectibix treatment. Your doctor will also check your blood 
levels of magnesium and calcium periodically during your treatment, and for up to 8 weeks after you 
have finished your treatment. If these levels are too low, your doctor may prescribe you appropriate 
supplements. 
 
If you experience severe diarrhoea please tell your doctor or nurse since you may lose a lot of water 
from your body (become dehydrated) and this could damage your kidneys. 
 
Tell your doctor if you use contact lenses and/or have a history of eye problems such as severe dry 
eye, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye. 
 
If you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision 
and/or sensitivity to light, please tell your doctor or nurse immediately as you may need urgent 
treatment (see “Possible side effects” below). 
 
Based on your age (older than 65 years) or general health, your doctor will discuss with you your 
ability to tolerate taking Vectibix with your chemotherapy treatment. 
 
Other medicines and Vectibix 
 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 
including medicines obtained without a prescription and herbal medicines. 
 
Vectibix should not be used in combination with bevacizumab (another monoclonal antibody used in 
cancer of the bowel) or with a chemotherapy combination known as “IFL”. 
 
Pregnancy and breast-feeding 
 
Vectibix has not been tested in pregnant women. It is important to tell your doctor if you are pregnant; 
think you may be pregnant; or plan to get pregnant. Vectibix could affect your unborn baby or ability 
to stay pregnant. 
 
If you are a woman of child bearing potential, you should use effective methods of contraception 
during treatment with Vectibix and for 2 months after the last dose. 
 
It is not recommended to breast-feed your baby during treatment with Vectibix and for 2 months after 
the last dose. It is important to tell your doctor if you plan to breast-feed. 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 



30 

Driving and using machines 
 
You should speak with your doctor before driving or using machines, as some side effects may impair 
your ability to do so safely. 
 
Vectibix contains sodium 
 
This medicine contains 3.45 mg sodium (main component of cooking/table salt) in each mL unit. This 
is equivalent to 0.017% of the recommended maximum daily dietary intake of sodium for an adult. 
 
 
3. How to use Vectibix 
 
Vectibix will be administered in a healthcare facility under the supervision of a doctor experienced in 
the use of anti-cancer medicines. 
 
Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow 
injection). 
 
The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) given once 
every two weeks. The treatment will usually be given over a period of approximately 60 minutes. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The most serious side effects and main side effects for Vectibix are listed below: 
 
Infusion reactions 
 
During or following treatment you may experience an infusion reaction. These can be mild or 
moderate (likely to occur in approximately 5 out of 100 people who take Vectibix), or severe (likely to 
occur in 1 out of 100 people who take Vectibix). Symptoms may include headache, rashes, itching or 
hives, flushing, swelling (face, lips, mouth, around the eyes, and throat area), rapid and irregular 
heartbeat, fast pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a 
decrease in blood pressure that may be severe or life-threatening and, very rarely, may lead to death. If 
you experience any of these symptoms, you should notify your doctor immediately. Your doctor may 
decide to reduce the rate of your infusion or discontinue your treatment with Vectibix. 
 
Allergic reactions 
 
Very rarely, serious allergic (hypersensitivity) reactions involving symptoms similar to an infusion 
reaction (see “Infusion reactions”) have occurred more than 24 hours after treatment and resulted in a 
fatal outcome. Seek medical attention immediately if you experience symptoms of an allergic reaction 
to Vectibix, including but not limited to difficulty breathing, chest tightness, a sensation of choking, 
dizziness, or fainting. 
 
Skin reactions 
 
Skin-related reactions are likely to occur in approximately 94 out of 100 people who take Vectibix and 
are usually mild to moderate. The skin rash commonly resembles acne and often involves the face, 
upper chest and back, but can affect any area of the body. Some rashes have been associated with 
redness, itching and flaking of the skin which can become severe. In some cases, it may cause infected 
sores requiring medical and/or surgical treatment, or cause severe skin infections that in rare cases 
could be fatal. In rare cases patients may experience blistering of the skin, mouth, eyes and genitals, 
which may indicate a severe skin reaction called “Stevens-Johnson syndrome” or blistering of the 



31 

skin, which may indicate a severe skin reaction called “toxic epidermal necrolysis”. If you experience 
blistering, you should notify your doctor immediately. Prolonged exposure to the sun can make the 
rash worse. Also, dry skin, fissures (cracks in the skin) on the fingers or toes, fingernail bed or toenail 
bed infection (paronychia) or inflammation has been reported. Once treatment is withheld or 
discontinued, the skin reactions will generally resolve. Your doctor may decide to treat the rash, adjust 
the dose or discontinue your treatment with Vectibix. 
 
Other side effects include: 
 
Very common: may affect more than 1 in 10 people 
 low red blood cell numbers (anaemia); low potassium levels in the blood (hypokalaemia); low 

magnesium levels in the blood (hypomagnesaemia); 
 eye inflammation (conjunctivitis); 
 local or widespread rash which may be bumpy (with or without spots), itchy, red or flaky; 
 hair loss (alopecia); mouth ulcers and cold sores (stomatitis); inflammation of the mouth 

(mucosal inflammation); 
 diarrhoea; nausea; vomiting; abdominal pain; constipation; decreased appetite; decreased 

weight; 
 extreme tiredness (fatigue); fever or high temperature (pyrexia); lack or loss of strength 

(asthenia); accumulation of fluid in the extremities (oedema peripheral); 
 back pain; 
 inability to sleep (insomnia); 
 cough; dyspnoea (breathing difficulties). 
 
Common: may affect up to 1 in 10 people 
 low white blood numbers (leucopenia); low calcium levels in the blood (hypocalcaemia); low 

phosphates in the blood (hypophosphataemia); high glucose in the blood (hyperglycaemia); 
 growth of eyelashes; flow of tears (lacrimation increased); redness of the eye (ocular 

hyperaemia); dry eye; itchy eyes (eye pruritus); eye irritation; eyelid inflammation (blepharitis); 
 skin ulcer; scab; excess hair growth (hypertrichosis); redness and swelling of palms of hands or 

soles of feet (hand-foot syndrome); excess sweating (hyperhidrosis); skin reaction (dermatitis); 
 spreading infection below the skin (cellulitis); hair follicle inflammation (folliculitis); localised 

infection; skin rash with pus-filled blisters (rash pustular); urinary tract infection; 
 nail disorder; breaking of the nails (onychoclasis); 
 dehydration; 
 dry mouth; indigestion (dyspepsia); rectal bleeding (rectal haemorrhage); lip inflammation 

(cheilitis); heartburn (gastroesophageal reflux); 
 chest pain; pain; chills; pain in the extremity; immune reaction (hypersensitivity); rapid heart 

rate (tachycardia); 
 blood clot in the lung (pulmonary embolism) the symptoms of which may be sudden onset of 

shortness of breath or chest pain; nose bleed (epistaxis); blood clot in a deep vein (deep vein 
thrombosis); high blood pressure (hypertension); flushing; 

 headache; dizziness; anxiety. 
 
Uncommon: may affect up to 1 in 100 people 
 blue colouration of the skin and mucous membranes (cyanosis); 
 ulcerative keratitis (a serious condition of ulceration of the front part of the eye (cornea) 

requiring urgent treatment); 
 keratitis (inflammation of the front part of the eye (cornea)); 
 skin cell death (skin necrosis); 
 severe skin reaction with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson 

syndrome); 
 severe skin reaction with blistering of the skin (toxic epidermal necrolysis); 



32 

 eyelid irritation; chapped lips and/or dry lips; eye infection; eyelid infection; nasal dryness; 
loosening of the nails (onycholysis); ingrowing nail; excessive hair growth (hirsutism); 

 inflammation of the lungs (interstitial lung disease). 
 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Vectibix 
 
Vectibix will be stored in the healthcare facility where it is used. 
 
Keep this medicine out of the sight and reach of children. 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Store in the original carton in order to protect from light. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
 
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 Vectibix contains 
 
 Each mL of concentrate contains 20 mg panitumumab. Each vial contains either 100 mg of 

panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL. 
 The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid (glacial) and 

water for injections. See section 2 “Vectibix contains sodium”. 
 
What Vectibix looks like and contents of the pack 
 
Vectibix is a colourless liquid that may contain visible particles and is supplied in a glass vial. Each 
pack contains one vial. 
 
Marketing Authorisation Holder and Manufacturer 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Marketing Authorisation Holder 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 



33 

Manufacturer 
Amgen Technology (Ireland) Unlimited Company 
Pottery Road 
Dun Laoghaire 
Co Dublin 
Ireland 
 
Manufacturer 
Amgen NV 
Telecomlaan 5-7 
1831 Diegem 
Belgium 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
s.a. Amgen n.v. 
Tel/Tél: +32 (0)2 7752711 
 

Lietuva 
Amgen Switzerland AG Vilniaus filialas 
Tel: +370 5 219 7474 

България 
Амджен България ЕООД 
Тел.: +359 (0)2 424 7440 

Luxembourg/Luxemburg 
s.a. Amgen 
Belgique/Belgien 
Tel/Tél: +32 (0)2 7752711 

Česká republika 
Amgen s.r.o. 
Tel: +420 221 773 500 
 

Magyarország 
Amgen Kft. 
Tel.: +36 1 35 44 700 

Danmark 
Amgen, filial af Amgen AB, Sverige 
Tlf: +45 39617500 
 

Malta 
Amgen B.V. 
The Netherlands 
Tel: +31 (0)76 5732500 

Deutschland 
AMGEN GmbH 
Tel.: +49 89 1490960 
 

Nederland 
Amgen B.V. 
Tel: +31 (0)76 5732500 

Eesti 
Amgen Switzerland AG Vilniaus filialas 
Tel: +372 586 09553 
 

Norge 
Amgen AB 
Tel: +47 23308000 

Ελλάδα 
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. 
Τηλ.: +30 210 3447000 
 

Österreich 
Amgen GmbH 
Tel: +43 (0)1 50 217 

España 
Amgen S.A. 
Tel: +34 93 600 18 60 
 

Polska 
Amgen Biotechnologia Sp. z o.o. 
Tel.: +48 22 581 3000 

France 
Amgen S.A.S. 
Tél: +33 (0)9 69 363 363 
 

Portugal 
Amgen Biofarmacêutica, Lda. 
Tel: +351 21 4220606 



34 

Hrvatska 
Amgen d.o.o. 
Tel: +385 (0)1 562 57 20 
 

România 
Amgen România SRL 
Tel: +4021 527 3000 

Ireland 
Amgen Ireland Limited 
Tel: +353 1 8527400 
 

Slovenija 
AMGEN zdravila d.o.o. 
Tel: +386 (0)1 585 1767 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Amgen Slovakia s.r.o. 
Tel: +421 2 321 114 49 

Italia 
Amgen S.r.l. 
Tel: +39 02 6241121 
 

Suomi/Finland 
Amgen AB, sivuliike Suomessa/Amgen AB, filial 
i Finland 
Puh/Tel: +358 (0)9 54900500 

Kύπρος 
C.A. Papaellinas Ltd 
Τηλ.: +357 22741 741 
 

Sverige 
Amgen AB 
Tel: +46 (0)8 6951100 

Latvija 
Amgen Switzerland AG Rīgas filiāle 
Tel: +371 257 25888 
 

United Kingdom 
Amgen Limited 
Tel: +44 (0)1223 420305 

 
This leaflet was last revised in 
 
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: 
 
Vectibix is intended for single use only. Vectibix should be diluted in sodium chloride 9 mg/mL 
(0.9%) solution for injection by healthcare professional using aseptic technique. Do not shake or 
vigorously agitate the vial. Vectibix should be inspected visually prior to administration. The solution 
should be colourless and may contain visible translucent-to-white, amorphous, proteinaceous 
particulates (which will be removed by in-line filtration). Do not administer Vectibix if its appearance 
is not as described above. Using only a 21-gauge or smaller diameter hypodermic needle, withdraw 
the necessary amount of Vectibix for a dose of 6 mg/kg. Do not use needle-free devices (e.g. vial 
adapters) to withdraw vial contents. Dilute in a total volume of 100 mL. Doses higher than 1,000 mg 
should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection. The final 
concentration should not exceed 10 mg/mL. The diluted solution should be mixed by gentle inversion, 
do not shake. 
 
Discard the vial and any liquid remaining in the vial after the single-use. 
 
The infusion line should be flushed with sodium chloride solution before and after Vectibix 
administration to avoid mixing with other medicinal products or intravenous solutions. 
 
Vectibix must be administered as an intravenous infusion via an infusion pump, using a low protein 
binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter. The 
recommended infusion time is approximately 60 minutes. Doses higher than 1,000 mg should be 
infused over approximately 90 minutes. 
 



35 

No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) 
solution for injection in polyvinyl chloride bags or polyolefin bags. 
 


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