Talzenna

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Talzenna 0.25 mg hard capsules  
Talzenna 1 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Talzenna 0.25 mg hard capsules 
 
Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib. 
 
Talzenna 1 mg hard capsules 
 
Each hard capsule contains talazoparib tosylate equivalent to 1 mg talazoparib. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Hard capsule (capsule). 
 
Talzenna 0.25 mg hard capsules 
 
Opaque, approximately 14.30 mm x 5.32 mm hard capsule with an ivory cap (printed with “Pfizer” in 
black) and a white body (printed with “TLZ 0.25” in black). 
 
Talzenna 1 mg hard capsules 
 
Opaque, approximately 14.30 mm x 5.32 mm hard capsule with a light red cap (printed with “Pfizer” 
in black) and a white body (printed with “TLZ 1” in black). 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Talzenna is indicated as monotherapy for the treatment of adult patients with germline 
BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients 
should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally 
advanced or metastatic setting unless patients were not suitable for these treatments (see section 5.1). 
Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior 
endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. 
 
4.2 Posology and method of administration 
 
Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of 
anticancer medicinal products. 
 



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Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of 
deleterious or suspected deleterious germline BRCA mutations determined by an experienced 
laboratory using a validated test method.  
 
Genetic counselling for patients with BRCA mutations should be performed according to local 
regulations, as applicable. 
 
Posology 
 
The recommended dose is 1 mg talazoparib once daily. Patients should be treated until disease 
progression or unacceptable toxicity occurs.  
 
Missing dose 
If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose 
should be taken at the usual time.  
 
Dose adjustments 
To manage adverse drug reactions, interruption of treatment or dose reduction based on severity and 
clinical presentation should be considered (Table 2). Recommended dose reductions are indicated in 
Table 1. 
 
Table 1. Dose adjustments for toxicities 

 Dose level 
Recommended starting dose 1 mg (one 1 mg capsule) once daily
First dose reduction 0.75 mg (three 0.25 mg capsules) once daily 
Second dose reduction 0.5 mg (two 0.25 mg capsules) once daily
Third dose reduction 0.25 mg (one 0.25 mg capsule) once daily 

 
Complete blood count should be obtained prior to starting Talzenna therapy and monitored monthly 
and as clinically indicated (see Table 2 and section 4.4).  
 
Table 2. Dose modification and management 

 Withhold Talzenna until 
levels resolve to 

Resume Talzenna 

Haemoglobin < 8 g/dL  ≥ 9 g/dL 
Resume Talzenna at next 
lower dose 

Platelet count < 50,000/μL  ≥ 75,000/μL 
Neutrophil count < 1,000/μL ≥ 1,500/µL 

Non-haematologic adverse 
reaction Grade 3 or Grade 4  Grade 1 

Consider resuming Talzenna 
at next lower dose or 
discontinue 

 
Concomitant treatment with inhibitors of P-glycoprotein (P-gp) 
Strong inhibitors of P-gp may lead to increased talazoparib exposure. Concomitant use of strong P-gp 
inhibitors during treatment with talazoparib should be avoided. Co-administration should only be 
considered after careful evaluation of the potential benefits and risks. If co-administration with a 
strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced to the next lower dose. 
When the strong P-gp inhibitor is discontinued, the Talzenna dose should be increased (after 
3‐5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the strong P-gp inhibitor 
(see section 4.5). 
 
Special populations 
 
Hepatic impairment 
No dose adjustment is required for patients with mild hepatic impairment (total bilirubin ≤ 1 × upper 
limit of normal [ULN] and aspartate aminotransferase (AST) > ULN, or total bilirubin > 1.0 to 
1.5 × ULN and any AST). Talzenna has not been studied in patients with moderate 



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(total bilirubin > 1.5 to 3.0 × ULN and any AST) or severe hepatic impairment (total bilirubin 
> 3.0 × ULN and any AST) (see section 5.2). Talzenna may only be used in patients with moderate or 
severe hepatic impairment if the benefit outweighs the potential risk, and the patient should be carefully 
monitored for hepatic function and adverse events.  
 
Renal impairment 
No dose adjustment is required for patients with mild renal impairment (60 mL/min ≤ creatinine 
clearance [CrCL] < 90 mL/min). For patients with moderate renal impairment 
(30 mL/min ≤ CrCL < 60 mL/min), the recommended starting dose of Talzenna is 0.75 mg once daily. 
For patients with severe renal impairment (15 mL/min ≤ CrCL < 30 mL/min), the recommended 
starting dose of Talzenna is 0.5 mg once daily. Talzenna has not been studied in patients with 
CrCL < 15 mL/min or patients requiring haemodialysis (see section 5.2).  
 
Elderly  
No dose adjustment is necessary in elderly (≥ 65 years of age) patients (see section 5.2). 
 
Paediatric population 
The safety and efficacy of Talzenna in children and adolescents < 18 years of age have not been 
established. No data are available. 
 
Method of administration  
 
Talzenna is for oral use. To avoid contact with the capsule content, the capsules should be swallowed 
whole, and must not be opened or dissolved. They can be taken with or without food (see section 5.2). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Breast-feeding (see section 4.6). 
 
4.4 Special warnings and precautions for use 
 
Myelosuppression  
 
Myelosuppression consisting of anaemia, leucopenia/neutropenia, and/or thrombocytopenia, have 
been reported in patients treated with talazoparib (see section 4.8). Talazoparib should not be started 
until patients have recovered from haematological toxicity caused by previous therapy (≤ Grade 1). 
 
Precautions should be taken to routinely monitor haematology parameters and signs and symptoms 
associated with anaemia, leucopenia/neutropenia, and/or thrombocytopenia in patients receiving 
talazoparib. If such events occur, dose modifications (reduction or interruption) are recommended (see 
section 4.2). Supportive care with or without blood and/or platelet transfusions and/or administration 
of colony stimulating factors may be used as appropriate.  
 
Myelodysplastic syndrome/Acute myeloid leukaemia 
 
Myelodysplastic syndrome/Acute Myeloid Leukaemia (MDS/AML) have been reported in patients 
who received poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, including 
talazoparib. Overall, MDS/AML has been reported in 2 out of 584 (0.3%) solid tumour patients treated 
with talazoparib in clinical studies. Potential contributing factors for the development of MDS/AML 
include previous platinum-containing chemotherapy, other DNA damaging agents or radiotherapy. 
Complete blood counts should be obtained at baseline and monitored monthly for signs of 
haematologic toxicity during treatment. If MDS/AML is confirmed, talazoparib should be 
discontinued. 
 



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Contraception in women of childbearing potential 
 
Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood 
lymphocytes and in an in vivo bone marrow micronucleus assay in rats but not mutagenic in Ames 
assay (see section 5.3), and may cause foetal harm when administered to a pregnant woman. Pregnant 
women should be advised of the potential risk to the foetus (see section 4.6). Women of childbearing 
potential should not become pregnant while receiving Talzenna and should not be pregnant at the 
beginning of treatment. A pregnancy test should be performed on all women of childbearing potential 
prior to treatment. 
 
A highly effective method of contraception is required for female patients during treatment with 
Talzenna, and for at least 7 months after completing therapy. Since the use of hormonal contraception 
is not recommended in patients with breast cancer, two non-hormonal and complementary 
contraception methods should be used (see section 4.6).  
 
Male patients with female partners of reproductive potential or pregnant partners should be advised to 
use effective contraception (even after vasectomy), during treatment with Talzenna and for at least 
4 months after the final dose.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Talazoparib is a substrate for drug transporters P-gp and Breast Cancer Resistance Protein (BCRP) and 
it is mainly eliminated by renal clearance as unchanged compound. 
 
Agents that may affect talazoparib plasma concentrations 
 
P-gp inhibitors  
Data from a drug-drug interaction study in patients with advanced solid tumours indicated that 
co-administration of multiple daily doses of a P-gp inhibitor, itraconazole 100 mg twice daily with a 
single 0.5 mg talazoparib dose increased talazoparib total exposure (AUCinf) and peak concentration 
(Cmax) by approximately 56% and 40%, respectively, relative to a single 0.5 mg talazoparib dose 
administered alone. Population pharmacokinetic (PK) analysis has also shown that concomitant use of 
strong P-gp inhibitors increased talazoparib exposure by 45%, relative to talazoparib given alone.  
 
Concomitant use of strong P-gp inhibitors (including but not limited to amiodarone, carvedilol, 
clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, 
ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, 
tipranavir, and verapamil) should be avoided. If co-administration with a strong P-gp inhibitor is 
unavoidable, the Talzenna dose should be reduced (see section 4.2). 
 
P-gp inducers  
Data from a drug-drug interaction study in patients with advanced solid tumours indicated that 
co-administration of single 1 mg talazoparib dose with multiple daily doses of a P-gp inducer, rifampin 
600 mg, with rifampin co-administered 30 minutes before talazoparib on the day of talazoparib dosing, 
increased talazoparib Cmax by approximately 37% whereas AUCinf was not affected relative to a single 
1 mg talazoparib dose administered alone. This is probably the net effect of both P-gp induction and 
inhibition by rifampin under the tested conditions in the drug-drug interaction study. No talazoparib 
dose adjustments are required when co-administered with rifampin. However, the effect of other P-gp 
inducers on talazoparib exposure has not been studied. Other P-gp inducers (including but not limited to 
carbamazepine, phenytoin, and St. John’s wort) may decrease talazoparib exposure.  
 
BCRP inhibitors  
The effect of BCRP inhibitors on PK of talazoparib has not been studied in vivo. Co-administration of 
talazoparib with BCRP inhibitors may increase talazoparib exposure. Concomitant use of strong 
BCRP inhibitors (including but not limited to curcumin and cyclosporine) should be avoided. If 
co-administration of strong BCRP inhibitors cannot be avoided, patient should be monitored for 
potential increased adverse reactions. 



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Effect of acid-reducing agents 
Population PK analysis indicates that co-administration of acid-reducing agents including proton 
pump inhibitors and histamine receptor 2 antagonists (H2RA), or other acid-reducing agents had no 
significant impact on the absorption of talazoparib. 
 
Systemic hormonal contraception 
Drug-drug interaction studies between talazoparib and oral contraceptives have not been conducted.   
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential/Contraception in males and females 
 
Women of childbearing potential should not become pregnant while receiving Talzenna and should 
not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of 
childbearing potential prior to treatment (see section 4.4). 
 
Women of childbearing potential must use highly effective forms of contraception (see section 4.4) 
prior to starting treatment with talazoparib, during treatment, and for 7 months after stopping 
treatment with talazoparib.  Since the use of hormonal contraception is not recommended in patients 
with breast cancer, two non-hormonal and complementary contraception methods should be used. 
Male patients with female partners of reproductive potential or pregnant partners should be advised to 
use effective contraception (even after vasectomy) during treatment with Talzenna, and for at least 
4 months after the final dose (see section 4.4). 
 
Pregnancy 
 
There are no data from the use of Talzenna in pregnant women. Studies in animals have shown 
embryo-foetal toxicity (see section 5.3). Talzenna may cause foetal harm when administered to a 
pregnant woman. Talzenna is not recommended during pregnancy or for women of childbearing 
potential not using contraception (see section 4.4).  
 
Breast-feeding 
 
It is unknown whether talazoparib is excreted in human breast milk. A risk to breast-fed children 
cannot be excluded and therefore breast-feeding is not recommended during treatment with Talzenna 
and for at least 1 month after the final dose.  
 
Fertility 
 
There is no information on fertility in patients. Based on non-clinical findings in testes (partially 
reversible) and ovary (reversible), Talzenna may impair fertility in males of reproductive potential (see 
section 5.3).  
 
4.7 Effects on ability to drive and use machines 
 
Talzenna may have a minor influence on the ability to drive and use machines. Fatigue/asthenia or 
dizziness may occur following administration of talazoparib. 
 
4.8 Undesirable effects  
 
Summary of the safety profile  
 
The overall safety profile of Talzenna is based on pooled data from 494 patients who received 
talazoparib at 1 mg daily in clinical studies for solid tumours, including 286 patients from a 
randomised Phase 3 study with germline BRCA-mutated (gBRCAm), HER2-negative locally 



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advanced or metastatic breast cancer and 83 patients from a nonrandomised Phase 2 study in patients 
with germline BRCA-mutated locally advanced or metastatic breast cancer. 
 
The most common (≥ 25%) adverse reactions in patients receiving talazoparib in these clinical studies 
were fatigue (57.1%), anaemia (49.6%), nausea (44.3%), neutropenia (30.2%), thrombocytopenia 
(29.6%), and headache (26.5%). The most common (≥ 10%) Grade ≥ 3 adverse reactions of 
talazoparib were anaemia (35.2%), neutropenia (17.4%), and thrombocytopenia (16.8%). 
 
Dose modifications (dose reductions or dose interruptions) due to any adverse reaction occurred in 
62.3% of patients receiving Talzenna. The most common adverse reactions leading to dose 
modifications were anaemia (33.0%), neutropenia (15.8%), and thrombocytopenia (13.4%). 
 
Permanent discontinuation due to an adverse reaction occurred in 3.6% of patients receiving Talzenna. 
The median duration of exposure was 5.4 months (range 0.03-61.1). 
 
Tabulated list of adverse reactions 
 
Table 3 summarises adverse reactions based on pooled dataset listed by system organ class, and 
frequency category. Frequency categories are defined as: very common (≥ 1/10) and common (≥ 1/100 
to < 1/10). Within each frequency grouping, adverse reactions are presented in order of decreasing 
seriousness. 
 
Table 3. Adverse reactions based on pooled dataset from 5 studies (N=494) 
System organ class 

Frequency 
Preferred term 

All grades* 
n (%) 

Grade 3 
n (%) 

Grade 4 
n (%) 

Blood and lymphatic system disorders 
Very common 

Thrombocytopeniaa 
Anaemiab 
Neutropeniac 
Leucopeniad 

Common 
Lymphopeniae 

 
 

146 (29.6) 
245 (49.6) 
149 (30.2) 
77 (15.6) 

 
30 (6.1) 

 
 

63 (12.8) 
172 (34.8) 
77 (15.6) 
24 (4.9) 

 
13 (2.6) 

 
 

20 (4.0) 
2 (0.4) 
9 (1.8) 
1 (0.2) 

 
0 (0.0) 

Metabolism and nutrition disorders 
Very common 

Decreased appetite 

 
 

100 (20.2) 

 
 

2 (0.4) 

 
 

0 (0.0) 
Nervous system disorders 

Very common 
Dizziness 
Headache 

Common 
Dysgeusia 

 
 

69 (14.0) 
131 (26.5) 

 
42 (8.5) 

 
 

1 (0.2) 
5 (1.0) 
 
0 (0.0) 

 
 

N/A 
N/A 

 
0 (0.0) 

Gastrointestinal disorders 
Very common 

Vomiting 
Diarrhoea 
Nausea 
Abdominal painf 

Common 
Stomatitis 
Dyspepsia 

 
 

110 (22.3) 
112 (22.7) 
219 (44.3) 
105 (21.3) 

 
32 (6.5) 
41 (8.3) 

 
 

7 (1.4) 
3 (0.6) 
4 (0.8) 
8 (1.6) 

 
0 (0.0) 
0 (0.0) 

 
 

0 (0.0) 
0 (0.0) 
N/A 
N/A 

 
0 (0.0) 
N/A 

Skin and subcutaneous tissue disorders 
Very common 

Alopeciag 

 
 

110 (22.3) 

 
 

N/A 

 
 

N/A 



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Table 3. Adverse reactions based on pooled dataset from 5 studies (N=494) 
System organ class 

Frequency 
Preferred term 

All grades* 
n (%) 

Grade 3 
n (%) 

Grade 4 
n (%) 

General disorders and administration site 
conditions 

Very common 
Fatigueh 

 
 
 

282 (57.1) 

 
 
 

17 (3.4) 

 
 
 

1 (0.2) 
Abbreviations: n=number of patients; N/A=not applicable. 
* There were no Grade 5 adverse drug reactions. 
a. Includes preferred terms of thrombocytopenia and platelet count decreased. 
b. Includes preferred terms of anaemia, haematocrit decreased and haemoglobin decreased. 
c. Includes preferred terms of neutropenia and neutrophil count decreased. 
d. Includes preferred terms of leucopenia and white blood cell count decreased. 
e. Includes preferred terms of lymphocyte count decreased and lymphopenia. 
f. Includes preferred terms of abdominal pain, abdominal pain upper, abdominal discomfort and abdominal pain 

lower. 
g. For talazoparib Grade 1 is 21% and Grade 2 is 2%. 
h. Includes preferred terms of fatigue and asthenia.
 
Description of selected adverse reactions 
 
Myelosuppression 
Myelosuppression-related adverse reactions of anaemia, neutropenia, and thrombocytopenia were very 
commonly reported in patients treated with talazoparib 1 mg/day. Grade 3 and Grade 4 
myelosuppression-related events were reported for anaemia 34.8% and 0.4%, neutropenia 15.6% and 
1.8%, and thrombocytopenia 12.8% and 4.0%. No deaths were reported due to 
myelosuppression-related adverse reactions. Myelosuppression-related adverse events associated with 
dose modifications were reported for up to approximately 30% of patients in the talazoparib 1 mg/day 
population and those associated with permanent study drug discontinuation were reported for less than 
1% of patients. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There is limited experience of overdose with talazoparib. No adverse reactions were reported in one 
patient who accidentally self-administered thirty 1-mg capsules of talazoparib on Day 1 and was 
immediately treated with gastric decontamination. Symptoms of overdose are not established. In the 
event of overdose, treatment with talazoparib should be stopped, and physicians should consider 
gastric decontamination, follow general supportive measures and treat symptomatically.  
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX60 
 
Mechanism of action  
 
Talazoparib is an inhibitor of PARP enzymes, PARP1, and PARP2. PARP enzymes are involved in 
cellular DNA damage response signalling pathways such as DNA repair, gene transcription, and cell 
death. PARP inhibitors (PARPi) exert cytotoxic effects on cancer cells by 2 mechanisms, inhibition of 



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PARP catalytic activity and by PARP trapping, whereby PARP protein bound to a PARPi does not 
readily dissociate from a DNA lesion, thus preventing DNA repair, replication, and transcription, 
thereby resulting in apoptosis and/or cell death. Treatment of cancer cell lines that are harbouring 
defects in DNA repair genes with talazoparib single agent leads to increased levels of γH2AX, a 
marker of double stranded DNA breaks, and results in decreased cell proliferation and increased 
apoptosis. Talazoparib anti-tumour activity was also observed in a patient-derived xenograft (PDX) 
BRCA mutant breast cancer model where the patient was previously treated with a platinum-based 
regimen. In this PDX model talazoparib decreased tumour growth and increased γH2AX level and 
apoptosis in the tumours.  
 
Cardiac electrophysiology 
 
The effect of talazoparib on cardiac repolarisation was evaluated using time-matched 
electrocardiograms (ECGs) in assessing the relationship between the change of the QT interval 
corrected for heart rate (QTc) from baseline and the corresponding plasma talazoparib concentrations 
in 37 patients with advanced solid tumours. Talazoparib did not have a clinically relevant effect on 
QTc prolongation at the maximum clinically recommended dose of 1 mg once daily. 
 
Clinical efficacy and safety  
 
Randomised Phase 3 study EMBRACA 
EMBRACA was an open-label, randomised, parallel, 2-arm multicentre study of Talzenna versus 
chemotherapy (capecitabine, eribulin, gemcitabine, vinorelbine) in patients with germline 
BRCA-mutated HER2-negative locally advanced or metastatic breast cancer who received no more 
than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease. Patients 
were required to have received treatment with an anthracycline and/or a taxane (unless 
contraindicated) in the neoadjuvant, adjuvant and/or metastatic setting. Patients with prior platinum 
therapy for advanced disease were required to have no evidence of disease progression during 
platinum therapy. No prior treatment with a PARP inhibitor was permitted.  
 
Of the 431 patients randomised in the EMBRACA study, 408 (95%) were centrally confirmed to have 
a deleterious or suspected deleterious gBRCAm using a clinical trial assay; out of which 354 (82%) 
were confirmed using the BRACAnalysis CDx®. BRCA mutation status (breast cancer susceptibility 
gene 1 [BRCA1] positive or breast cancer susceptibility gene 2 [BRCA2] positive) was similar across 
both treatment arms. 
 
A total of 431 patients were randomised 2:1 to receive Talzenna 1 mg capsules once daily or 
chemotherapy at standard doses until progression or unacceptable toxicity. Of the 431 patients 
randomised onto EMBRACA, 287 were randomised to the Talzenna arm and 144 to the chemotherapy 
arm. Randomisation was stratified by prior use of chemotherapy for metastatic disease (0 versus 1, 2, 
or 3), by triple-negative disease status (triple-negative breast cancer [TNBC] versus non-TNBC), and 
history of central nervous system metastasis (yes versus no).  
 
Patient demographic, baseline, and disease characteristics were generally similar between the study 
treatment arms (see Table 4).  
 

Table 4. Demographic, baseline, and disease characteristics – EMBRACA study  
 Talazoparib 

(N=287) 
Chemotherapy 

(N=144) 
Median age (y [range]) 45.0 (27.0, 84.0) 50.0 (24.0, 88.0) 
Age category (y), n (%)   

< 50 182 (63.4%) 67 (46.5%) 
50 to < 65 78 (27.2%) 67 (46.5%) 
≥ 65 27 (9.4%) 10 (6.9%) 

Gender, n (%)   
Female 283 (98.6%) 141 (97.9%) 
Male 4 (1.4%) 3 (2.1%) 



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Table 4. Demographic, baseline, and disease characteristics – EMBRACA study  
 Talazoparib 

(N=287) 
Chemotherapy 

(N=144) 
Race, n (%)  

Asian 31 (10.8%) 16 (11.1%) 
Black or African American 12 (4.2%) 1 (0.7%) 
White 192 (66.9%) 108 (75.0%)
Other 5 (1.7%) 1 (0.7%) 
Not reported 47 (16.4%) 18 (12.5%) 

ECOG performance status, n (%)   
0 153 (53.3%) 84 (58.3%) 
1 127 (44.3%) 57 (39.6%) 
2 6 (2.1%) 2 (1.4%) 
Missing 1 (0.3%) 1 (0.7%) 

Hormone receptor status, n (%)   
HER2-positive 0 (0.0%) 0 (0.0%) 
Triple-negative  130 (45.3%) 60 (41.7%) 
Hormone receptor-positive (ER positive or 
PgR positive) 

157 (54.7%) 84 (58.3%) 

BRCA status by central or local laboratory assessment, 
n (%) 

287 (100.0%) 144 (100.0%) 

BRCA1-mutation positive 133 (46.3%) 63 (43.8%) 
BRCA2-mutation positive 154 (53.7%) 81 (56.3%) 

Time from initial diagnosis of breast cancer to diagnosis of advanced breast cancer (years)  
n 286 144 
Median 1.9 2.7 
Minimum, maximum 0, 22 0, 24 

Categories for time from initial diagnosis of breast cancer to diagnosis of advanced breast cancer
< 12 months 108 (37.6%) 42 (29.2%) 
≥ 12 months 178 (62.0%) 102 (70.8%)

Number of prior cytotoxic regimens for locally advanced or metastatic disease
Mean (Std Dev) 0.9 (1.01) 0.9 (0.89) 
Median 1 1 
Minimum, maximum 0, 4 0, 3 

Number of patients who received prior cytotoxic regimens for locally advanced or metastatic 
disease, n (%) 

0 111 (38.7%) 54 (37.5%) 
1 107 (37.3%) 54 (37.5%) 
2 57 (19.9%) 28 (19.4%) 
3 11 (3.8%) 8 (5.6%) 
≥ 4 1 (0.3%) 0 (0.0%) 

Number of patients who received following prior therapies, n (%)
Taxane 262 (91.3%) 130 (90.3%)
Anthracycline 243 (84.7%) 115 (79.9%)
Platinum 46 (16.0%) 30 (20.8%) 

Abbreviations: BRCA=breast cancer susceptibility gene; ER=estrogen receptor; HER2=human epidermal 
growth factor receptor 2; N=number of patients; n=number of patients in category; PgR=progesterone receptor. 
 
The primary efficacy endpoint was progression-free survival (PFS) evaluated according to Response 
Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by blinded independent central 
review (BICR). The secondary objectives were objective response rate (ORR), overall survival (OS), 
safety, and PK.  
 
The study demonstrated a statistically significant improvement in PFS for Talzenna compared with 
chemotherapy (see Table 5). The OS interim analysis was performed at 51% for the total number of 
planned events. Efficacy data for EMBRACA based on the primary analysis as assessed by the 



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independent review and investigator are summarised in Table 5. The Kaplan-Meier curves for PFS is 
displayed in Figure 1.  
 

Table 5. Summary of efficacy results – EMBRACA study  
 Talazoparib Chemotherapy 

Progression-free survival by BICR N=287 N=144 
Events, number (%) 186 (65%) 83 (58%) 
Median (95% CI), months 8.6 (7.2, 9.3) 5.6 (4.2, 6.7) 
Hazard ratioa (95% CI)  0.54 (0.41, 0.71) 
2-sided p-valueb p<0.0001

Overall survival (interim analysis)c N=287 N=144 
Events, number (%) 108 (38%) 55 (38%) 
Median (95% CI), months 22.3 (18.1, 26.2) 19.5 (16.3, 22.4) 
Hazard ratio (95% CI) 0.76 (0.55, 1.06) 
2-sided p-valueb p=0.1053 

Objective response by investigatord,e N=219 N=114 
ORR (%, 95% CI) 62.6 (55.8, 69.0) 27.2 (19.3, 36.3) 
Odds ratio (95% CI) 4.99 (2.93, 8.83) 
2-sided p-valuef p<0.0001 

Duration of response by investigatord N=137 N=31 
Median (IQR), months 5.4 ( 2.8, 11.2) 3.1 (2.4, 6.7) 

Abbreviations: BICR=blinded independent central review; CI=confidence interval; CMH=Cochran-
Mantel-Haenszel; CR=complete response; IQR=interquartile range; ITT=intent-to-treat; ORR=objective 
response rate; OS=overall survival; PR=partial response; RECIST 1.1=Response Evaluation Criteria in 
Solid Tumors version 1.1. 
a. Hazard ratio was based on stratified Cox regression model with treatment as the only covariate 

(stratification factors: number of prior cytotoxic chemotherapy regimens, triple-negative status, history 
of central nervous system metastasis) and was relative to overall chemotherapy with < 1 favouring 
talazoparib. 

b. Stratified Log-rank test. 
c. 51% of the projected final number of OS events occurred (163 of 321 deaths). 
d. Conducted in ITT with measurable disease population who had an objective response. The complete 

response rate was 5.5% for talazoparib compared to 0% for the chemotherapy arm. 
e. Per RECIST 1.1, confirmation of CR/PR was not required. 
f. Stratified CMH test. 

 



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Figure 1 shows the Kaplan-Meier curve for the EMBRACA study. 
 
Figure 1. Kaplan-Meier curves of PFS – EMBRACA study 
 

0 3 6 9 12 15 18 21 24 27 30 33 36 39
Time (Month)

0

10

20

30

40

50

60

70

80

90

100

Pr
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Fr
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(%
)

Talazoparib
 Median PFS=8.6 months 
 95% CI (7.2, 9.3)
Chemotherapy
 Median PFS=5.6 months 
 95% CI (4.2, 6.7)
Hazard Ratio=0.54
95% CI (0.41, 0.71)
p<0.0001

287 229 148 91 55 42 29 23 16 12 5 3 1Talazoparib
144 68 34 22 9 8 4 2 2 1Chemotherapy

Number of patients at risk

 
Abbreviations: CI=confidence interval; PFS=progression-free survival. 
 
A series of prespecified subgroup PFS analyses was performed based on prognostic factors and 
baseline characteristics to investigate the internal consistency of treatment effect. Consistent with the 
overall results, a reduction in the risk of disease progression or death in favour of the talazoparib arm 
was observed in all individual patient subgroups (Figure 2).  
 
Figure 2. Forest plot of PFS analyses for key subgroups – EMBRACA study 
 

Abbreviations: aBC=advanced breast cancer; CI=confidence interval; CNS=central nervous system; HR+=hormone 
receptor-positive; ITT=intent-to-treat; PCT=physician’s choice treatment (chemotherapy); PFS=progression-free 
survival; TNBC=triple-negative breast cancer.

 



13 

Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
talazoparib in all subsets of the paediatric population in breast cancer (see section 4.2 for information 
on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Talazoparib exposure generally increased proportionally with dose across the range of 0.025 mg to 
2 mg after daily administration of multiple doses. Following repeated daily dosing of 1 mg talazoparib 
to patients, the geometric mean (% coefficient of variation [CV%]) area under the plasma 
concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) of talazoparib at 
steady-state was in the range of 126 (107) ng•hr/mL to 208 (37) ng•hr/mL and 11 (90) ng/mL to 
19 (27) ng/mL, respectively. Following repeated daily dosing, plasma talazoparib concentrations 
reached steady-state within 2 to 3 weeks. The median accumulation ratio of talazoparib following 
repeated oral administration of 1 mg once daily was in the range of 2.3 to 5.2. Talazoparib is a 
substrate of P-gp and BCRP transporters. 
 
Absorption 
 
Following oral administration of talazoparib, the median time to Cmax (Tmax) was generally between 
1 to 2 hours after dosing. The absolute bioavailability study has not been conducted in humans. 
However, based on urinary excretion data the absolute bioavailability is at least 41% with fraction 
absorbed of at least 69% (see Elimination). No significant effect of acid-reducing agents on 
talazoparib exposure is expected, given sufficient solubility of talazoparib at all pHs between 1 and 
6.8. Twenty-eight percent (28%) of the patients in the pivotal study were taking acid-reducing agents, 
mainly proton pump inhibitors.  
 
The effect of food 
Food intake decreased the rate but not the extent of talazoparib absorption. Following a single oral 
dose of talazoparib with high-fat, high-calorie food (approximately 827 calories, 57% fat), the mean 
Cmax of talazoparib was decreased by approximately 46%, the median Tmax was delayed from 1 to 
4 hours, while the AUCinf was not affected. Based on these results, Talzenna can be administered with 
or without food (see section 4.2). 
 
Distribution 
 
The population mean apparent volume of distribution (Vss/F) of talazoparib was 420 L. In vitro, 
talazoparib is approximately 74% bound to plasma proteins with no concentration dependence over the 
concentration range of 0.01 µM to 1 µM. Renal impairment does not appear to impact talazoparib 
protein binding as there was no obvious trend in the mean talazoparib fraction of unbound drug (fu) in 
human plasma in vivo with worsening renal function. 
 
Biotransformation 
 
Talazoparib undergoes minimal hepatic metabolism in humans. Following oral administration of a 
single 1 mg dose of [14C]talazoparib to humans, no major circulating metabolites were identified in 
plasma, and talazoparib was the only circulating drug-derived entity identified. No metabolites that 
individually represented more than 10% of the administered dose were recovered in the urine or faeces.  
 
In vitro, talazoparib was not an inhibitor of cytochrome (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, 
CYP2C19, CYP2D6, or CYP3A4/5 or inducer of CYP1A2, CYP2B6, or CYP3A4 at clinically relevant 
concentrations. 
 
In vitro, talazoparib did not inhibit any of the major intestinal, hepatic or renal membrane transporters 
(P-gp, BCRP, organic anion transporting polypeptide [OATP]1B1, OATP1B3, organic cationic 



14 

transporter [OCT]1, OCT2, organic anion transporter [OAT]1, OAT3, bile salt export pump [BSEP], 
multidrug and toxin extrusion [MATE]1 and MATE2-K) at clinically relevant concentrations.  
 
In vitro, talazoparib did not inhibit any of the major uridine-diphosphate glucuronosyltransferase 
(UGT) isoforms (1A1, 1A4, 1A6, 1A9, 2B7, and 2B15) at clinically relevant concentrations. 
 
Elimination 
 
Renal elimination of unchanged drug (passive filtration and active secretion) is the major route of 
talazoparib elimination. P-gp is likely involved in talazoparib active renal secretion. The mean 
(±standard deviation) terminal plasma half-life of talazoparib was 90 (±58) hours and the population 
mean (inter-subject variability) apparent oral clearance (CL/F) was 6.5 (31%) L/h in cancer patients. 
In 6 female patients given a single oral dose of [14C]talazoparib, a mean of 69% (±8.6%) and 20% 
(±5.5%) of the total administered radioactive dose was recovered in urine and faeces, respectively. 
Excretion of unchanged talazoparib in urine was the major route of elimination accounting for 55% of 
the administered dose, while unchanged talazoparib recovered in the faeces accounted for 14%. 
 
Age, sex, and body weight 
 
A population PK analysis was conducted using data from 490 patients with cancer to evaluate the 
impact of age (ranging from 18 to 88 years), sex (53 males and 437 females), and body weight 
(ranging from 35.7 kg to 162 kg) on the PK of talazoparib. The results have shown that age, sex, and 
body weight had no clinically relevant effect on the PK of talazoparib. 
 
Race 
 
Based on a population PK analysis that included 490 patients, where 41 patients were Asian and 
449 patients were Non-Asian (361 White, 16 Black, 9 Others, and 63 Not reported), talazoparib CL/F 
was higher in Asian patients compared to Non-Asian patients, leading to 19% lower exposure (AUC) 
in Asian patients. 
 
Paediatric population 
 
Pharmacokinetics of talazoparib have not been evaluated in patients < 18 years of age.  
 
Renal impairment 
 
Data from a PK trial in advanced cancer patients with varying degrees of renal impairment indicated 
that talazoparib total exposure (AUC0-24) after multiple talazoparib once daily doses increased by 92% 
and 169% in patients with moderate (eGFR 30 – < 60 mL/min) and severe (eGFR < 30 mL/min) renal 
impairment, respectively, relative to patients with normal renal function (eGFR ≥ 90 mL/min). 
Talazoparib Cmax increased by 90% and 107% in patients with moderate and severe renal impairment, 
respectively, relative to patients with normal renal function. Talazoparib exposure was similar for 
patients with mild renal impairment (eGFR 60 – < 90 mL/min) and those with normal renal function. 
In addition, based on a population PK analysis that included 490 patients, where 132 patients had mild 
renal impairment (60 mL/min ≤ CrCL < 90 mL/min), 33 patients had moderate renal impairment 
(30 mL/min ≤ CrCL < 60 mL/min), and 1 patient had severe renal impairment 
(CrCL < 30 mL/min),talazoparib CL/F was decreased by 14% and 37% in patients with mild and 
moderate renal impairment, corresponding to 17% and 59% increase in AUC, respectively, when 
compared to patients with normal renal function (CrCL ≥ 90 mL/min). The PK of talazoparib have not 
been studied in patients requiring haemodialysis (see section 4.2). 
 
Hepatic impairment 
 
Based on a population PK analysis that included 490 patients, where 118 patients had mild hepatic 
impairment (total bilirubin ≤ 1.0 × ULN and AST > ULN, or total bilirubin > 1.0 to 1.5 × ULN and 
any AST), mild hepatic impairment had no effect on the PK of talazoparib. The PK of talazoparib 



15 

have not been studied in patients with moderate (total bilirubin > 1.5 to 3.0 × ULN and any AST) or 
severe hepatic impairment (total bilirubin > 3.0 × ULN and any AST) (see section 4.2). 
 
5.3 Preclinical safety data 
 
Carcinogenicity 
 
Carcinogenicity studies have not been conducted with talazoparib. 
 
Genotoxicity 
 
Talazoparib was not mutagenic in a bacterial reverse mutation (Ames) test. Talazoparib was clastogenic 
in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo 
micronucleus assay in rats at exposures similar to clinically relevant doses. This clastogenicity is 
consistent with genomic instability resulting from the primary pharmacology of talazoparib, indicating 
the potential for genotoxicity in humans. 
 
Repeat-dose toxicity 
 
In repeat-dose toxicity studies in rats and in dogs, the main findings at subtherapeutic exposures 
included bone marrow hypocellularity with dose-dependent decrease in haematopoietic cells, depletion 
of lymphoid tissue in multiple organs and atrophy and/or degenerative changes in testes, epididymis 
and seminiferous tubules. Additional findings at higher exposures included dose-dependent increase in 
apoptosis/necrosis in the gastrointestinal (GI) tract, liver and ovary. Most of the histopathologic 
findings were generally reversible while the testes findings were partially reversible after 4 weeks of 
dosing cessation. These toxicity findings are consistent with the pharmacology of talazoparib and its 
tissue distribution pattern.  
 
Developmental toxicology 
 
In an embryo-foetal development study in rats, talazoparib resulted in embryo-foetal death, foetal 
malformation (depressed eye bulge, small eye, split sternebrae, fused cervical vertebral arch) and 
structural variations in bones at a maternal systemic AUC24 exposure approximately 0.09-fold the 
relevant human exposure at the recommended dose. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsule content 
 
Silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide) 
 
0.25 mg capsule shell 
 
Hypromellose (HPMC)  
Yellow iron Oxide (E172) 
Titanium dioxide (E171) 
 
1 mg capsule shell 
 
Hypromellose (HPMC) 
Red iron oxide (E172) 
Yellow iron oxide (E172) 
Titanium dioxide (E171) 
 



16 

Printing ink 
 
Shellac (E904) 
Propylene glycol (E1520) 
Ammonium hydroxide (E527) 
Black iron oxide (E172) 
Potassium hydroxide (E525) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Talzenna 0.25 mg hard capsules 
 
High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal 
liner. Pack size: cartons of 30 capsules in a HDPE bottle. 
 
Polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) perforated unit dose blister with an 
aluminum peel off foil lidding. Pack sizes: cartons of 30 × 1 capsules, or 60 × 1 capsules, or 
90 × 1 capsules in unit dose blisters. 
 
Talzenna 1 mg hard capsules 
 
High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal 
liner. Pack size: cartons of 30 capsules in a HDPE bottle. 
 
Polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) perforated unit dose blister with an 
aluminum peel off foil lidding. Pack size: cartons of 30 × 1 capsules in unit dose blisters. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 



17 

8. MARKETING AUTHORISATION NUMBER(S)  
 
Talzenna 0.25 mg hard capsules 
EU/1/19/1377/001 
EU/1/19/1377/002 
EU/1/19/1377/003 
EU/1/19/1377/004 
 
Talzenna 1 mg hard capsules 
EU/1/19/1377/005 
EU/1/19/1377/006 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 June 2019 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.  



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 

  



19 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Excella GmbH & Co. KG 
Nürnberger Str. 12 
90537 Feucht 
Germany 
 
 
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 (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 
months following authorisation. 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



22 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BOTTLE OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Talzenna 0.25 mg hard capsules 
talazoparib  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Hard capsule 
30 capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
Swallow whole. Do not open, crush or chew the capsules. 
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



23 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1377/001 (30 hard capsules) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Talzenna 0.25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 
  



24 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Talzenna 0.25 mg hard capsules 
talazoparib  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Hard capsule 
30 capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. Swallow whole. 
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



25 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1377/001 (30 hard capsules) 
 
 
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 
 
 
  



26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BLISTER OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Talzenna 0.25 mg hard capsules 
talazoparib  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Hard capsule 
30 × 1 capsules 
60 × 1 capsules 
90 × 1 capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
Swallow whole. Do not open, crush or chew the capsules. 
 
 
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 
 
 



27 

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 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1377/002 (30 hard capsules) 
EU/1/19/1377/003 (60 hard capsules) 
EU/1/19/1377/004 (90 hard capsules)  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Talzenna 0.25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 
  



28 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Talzenna 0.25 mg capsules 
talazoparib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



29 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BOTTLE OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Talzenna 1 mg hard capsules 
talazoparib  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Hard capsule 
30 capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
Swallow whole. Do not open, crush or chew the capsules. 
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



30 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1377/005 (30 hard capsules) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Talzenna 1 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 
  



31 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Talzenna 1 mg hard capsules 
talazoparib  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Hard capsule 
30 capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. Swallow whole.  
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



32 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1377/005 (30 hard capsules) 
 
 
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 
 
 
  



33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BLISTER OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Talzenna 1 mg hard capsules 
talazoparib  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Hard capsule 
30 × 1 capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
Swallow whole. Do not open, crush or chew the capsules. 
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



34 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1377/006 (30 hard capsules) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Talzenna 1 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 
  



35 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Talzenna 1 mg capsules 
talazoparib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



37 

Package leaflet: Information for the patient 
 

Talzenna 0.25 mg hard capsules 
Talzenna 1 mg hard capsules 

talazoparib 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Talzenna is and what it is used for  
2. What you need to know before you take Talzenna  
3. How to take Talzenna  
4. Possible side effects  
5. How to store Talzenna  
6. Contents of the pack and other information 
 
 
1. What Talzenna is and what it is used for 
 
What Talzenna is and how it works 
Talzenna contains the active substance talazoparib. It is a type of anticancer medicine known as a 
‘PARP (poly-ADP ribose polymerase) inhibitor’.  
 
Patients with changes (mutations) in genes called BRCA are at risk of developing some forms of 
cancer. Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in certain 
cancer cells. As a result, the cancer cells can no longer repair themselves and they die. 
 
What Talzenna is used for 
Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer 
who have an abnormal inherited BRCA gene.  
 
Talzenna is used when the cancer has spread beyond the original tumour or to other parts of the body.   
 
Your healthcare provider will perform a test to make sure that Talzenna is right for you. 
 
If you have any questions about how Talzenna works or why this medicine has been prescribed for 
you, ask your doctor. 
 
 
2. What you need to know before you take Talzenna  
 
Do not take Talzenna 
- If you are allergic to talazoparib or any of the other ingredients of this medicine (listed in 

section 6). 
- If you are breast-feeding. 



38 

 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before taking Talzenna and during your treatment if you 
experience signs or symptoms described in this section. 
 
Low blood cell counts 
Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell 
count (neutropenia), or blood platelet count (thrombocytopenia). Signs and symptoms you need to 
look out for include: 
- Anaemia: Being short of breath, feeling very tired, pale skin, or fast heartbeat – these may be 

signs of a low red blood cell count 
- Neutropenia: Infection, developing chills or shivering, or fever – these may be signs of a low 

white blood cell count 
- Thrombocytopenia: Bruising or bleeding for longer than usual if you hurt yourself – these may 

be signs of a low blood platelet count 
 

You will have regular blood tests during treatment with Talzenna to check your blood cells (white 
blood cells, red blood cells, and platelets). 
 
Serious problems with the bone marrow  
Rarely, low blood cell counts may be a sign of more serious problems with the bone marrow such as 
myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Your doctor may want to test 
your bone marrow to check for these problems. 
 
Male and female contraception 
Women who can become pregnant and men with partners who are or can become pregnant should use 
effective contraception.  
Please see section “Male and female contraception” below. 
 
Children and adolescents 
Talzenna is not to be used in children or adolescents (under 18 years of age). 
 
Other medicines and Talzenna 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines. This includes medicines obtained without a prescription and herbal medicines. This is 
because Talzenna can affect the way some other medicines work. Also some medicines can affect the 
way Talzenna works. 
 
In particular, the following may increase the risk of side effects with Talzenna: 
- Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine and verapamil – 

generally used to treat heart problems. 
- Clarithromycin and erythromycin antibiotics – used to treat bacterial infections. 
- Itraconazole and ketoconazole – used to treat fungal infections. 
- Cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir and tipranavir – used 

to treat HIV infections/AIDS. 
- Ciclosporin – used in organ transplantation to prevent rejection. 
- Lapatinib – used to treat patients with certain types of breast cancer. 
- Curcumin (e.g. found in turmeric root) in some medicines (see also section Talzenna with food 

and drink below). 
 

The following medicines may reduce the effect of Talzenna: 
- Carbamazepine and phenytoin – anti-epileptics used to treat seizures or fits. 
- St. John’s wort (Hypericum perforatum) – a herbal remedy used to treat mild depression and 

anxiety. 
 



39 

Talzenna with food and drink 
Do not use curcumin in food supplements while you are taking Talzenna as it may increase Talzenna’s 
side effects. Curcumin is found in turmeric root and you should not use large amounts of turmeric 
root, but using spices in food is not likely to cause a problem. 
 
Pregnancy 
Talzenna could harm an unborn baby. If you are pregnant or breast-feeding, think you may be 
pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 
medicine. Your doctor will perform a pregnancy test prior to starting Talzenna. 
 
- You should not use Talzenna if you are pregnant. 
- You should not become pregnant while taking Talzenna. 
- Discuss contraception with your doctor if there is any possibility that you or your partner may 

become pregnant.  
 
Male and female contraception 
Women who are able to become pregnant should use effective birth control (contraception) during 
treatment with Talzenna and for at least 7 months after the last dose of Talzenna. Since the use of 
hormonal contraception is not recommended if you have breast cancer, you should use two 
non-hormonal contraception methods. 
Talk to your healthcare provider about birth control methods that may be right for you. 
 
Men with female partners who are pregnant or able to become pregnant should use effective birth 
control (contraception), even after a vasectomy, during treatment with Talzenna and for at least 
4 months after the last dose.  
 
Breast-feeding 
You should not breast-feed while taking Talzenna and for at least 1 month after the last dose. It is not 
known if Talzenna passes into breast milk. 
 
Fertility 
Talazoparib may reduce fertility in men. 
 
Driving and using machines 
Talzenna may have a minor influence on the ability to drive and use machines. If you feel dizzy, weak, 
or tired (these are very common side effects of Talzenna), you should not drive or use machines. 
 
 
3. How to take Talzenna 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
How much to take 
The recommended dose is one 1-mg capsule taken by mouth once daily. 
 
If you get certain side effects while you are taking Talzenna (see section 4), your doctor may lower 
your dose or stop treatment, either temporarily or permanently. The dose may be lowered to 0.75 mg 
(taken as three 0.25-mg capsules) once daily, or 0.5 mg (two 0.25-mg capsules) once daily, or 0.25 mg 
(one 0.25-mg capsule) once daily. 
 
Swallow the capsule whole with a glass of water. Do not chew or crush the capsules. You can take 
Talzenna with food or between meals. Do not open the capsules. Contact with the capsule content 
should be avoided. 
 



40 

If you take more Talzenna than you should 
If you have taken more Talzenna than your normal dose, contact your doctor or nearest hospital right 
away. Urgent treatment may be necessary. 
 
Take the carton and this leaflet so that the doctor knows what you have been taking. 
 
If you forget to take Talzenna 
If you miss a dose or vomit, take your next dose as scheduled. Do not take a double dose to make up 
for the forgotten or vomited capsules. 
 
If you stop taking Talzenna 
Do not stop taking Talzenna unless your doctor tells you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Tell your doctor straight away if you notice any of the following symptoms which could be a sign 
of serious blood disorder:  
 
Very common (may affect more than 1 in 10 people) 
- Being short of breath, feeling very tired, having pale skin, or fast heartbeat – these may be signs 

of a low red blood cell count (anaemia). 
- Infection, developing chills or shivering, or fever or feeling hot – these may be signs of a low 

white blood cell count (neutropenia). 
- Bruising or bleeding for longer than usual if you hurt yourself – these may be signs of a low 

blood platelet count (thrombocytopenia). 
 
Talk to your doctor if you get any other side effects. These can include: 
 
Very common (may affect more than 1 in 10 people) 
- Low counts of white blood cells, red blood cells, and blood platelets  
- Decreased appetite 
- Feeling dizzy 
- Headache 
- Feeling sick (nausea) 
- Being sick (vomiting) 
- Diarrhoea 
- Pain in the abdomen 
- Hair loss 
 
Common (may affect up to 1 in 10 people) 
- Alteration in taste (dysgeusia) 
- Indigestion 
- Mouth inflammation 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 



41 

5. How to store Talzenna 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and the bottle or blister 
after EXP. The expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Do not use this medicine if the pack is damaged or shows signs of tampering. 
 
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 Talzenna contains  
- The active substance is talazoparib. Talzenna hard capsules come in different strengths. 
- Talzenna 0.25 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 

0.25 mg talazoparib. 
- Talzenna 1 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 1 mg 

talazoparib. 
The other ingredients are: 
- Capsule content: silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and 

silicone dioxide).  
- 0.25 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), and titanium dioxide 

(E171)  
- 1 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), titanium dioxide (E171), 

and red iron oxide (E172) 
 
Printing ink: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron 
oxide (E172), and potassium hydroxide (E525). 
 
What Talzenna looks like and contents of the pack 
Talzenna 0.25 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsules, with an 
ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black). 
 
Talzenna 1 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsules with a light 
red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black). 
 
Talzenna 0.25 mg is available in perforated unit dose blister packs of 30, or 60, or 90 hard capsules 
and in plastic bottles of 30 hard capsules. 
 
Talzenna 1 mg is available in perforated unit dose blister packs of 30 hard capsules and in plastic 
bottles of 30 hard capsules. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 



42 

Manufacturer 
Excella GmbH & Co. KG  
Nürnberger Strasse 12  
90537 Feucht  
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 

Belgique/België/Belgien 
Pfizer S.A. / N.V. 
Tél/Tel: +32 (0)2 554 62 11 

Lietuva 
Pfizer Luxembourg SARL filialas Lietuvoje 
Tel. + 370 52 51 4000 

България 
Пфайзер Люксембург САРЛ, Клон България 
Тел.: +359 2 970 4333 

Luxembourg/Luxemburg 
Pfizer S.A. 
Tél/Tel: +32 (0)2 554 62 11 

Česká republika 
Pfizer PFE, spol. s r.o. 
Tel.: +420 283 004 111 

Magyarország 
Pfizer Kft. 
Tel.: +36-1-488-37-00 

Danmark 
Pfizer ApS 
Tlf: +45 44 20 11 00 
 

Malta 
Vivian Corporation Ltd 
Tel. +356 21344610 

Deutschland 
Pfizer Pharma GmbH 
Tel: +49 (0)30 550055 51000 
  

Nederland 
Pfizer BV 
Tel: +31 (0)10 406 43 01 

Eesti 
Pfizer Luxembourg SARL Eesti filiaal  
Tel.: +372 666 7500 

Norge 
Pfizer Norge AS 
Tlf: +47 67 52 61 00 
 

Ελλάδα 
Pfizer Ελλάς A.E. 
Τηλ.: +30 210 6785 800 

Österreich 
Pfizer Corporation Austria Ges.m.b.H. 
Tel: +43 (0)1 521 15-0 

España 
Pfizer, S.L. 
Tel: +34 91 490 99 00 

Polska 
Pfizer Polska Sp. z o.o. 
Tel.:+48 22 335 61 00 
 

France 
Pfizer  
Tél: +33 (0)1 58 07 34 40 

Portugal 
Pfizer Biofarmacêutica, Sociedade Unipessoal Lda 
Tel: +351 21 423 5500 

Hrvatska 
Pfizer Croatia d.o.o. 
Tel: +385 1 3908 777 

România 
Pfizer Romania S.R.L. 
Tel: +40 (0) 21 207 28 00 

Ireland 
Pfizer Healthcare Ireland 
Tel: 1800 633 363 (toll free) 
+44 (0)1304 616161 

Slovenija 
Pfizer Luxembourg SARL 
Pfizer, podružnica za svetovanje s področja 
farmacevtske dejavnosti, Ljubljana 
Tel.: + 386 (0)1 52 11 400 
 



43 

Ísland 
Icepharma hf. 
Sími: +354 540 8000 

Slovenská republika 
Pfizer Luxembourg SARL, organizačná zložka  
Tel.: + 421 2 3355 5500 

Italia 
Pfizer S.r.l. 
Tel: +39 06 33 18 21 

Suomi/Finland 
Pfizer Oy 
Puh./Tel: +358 (0)9 43 00 40 

Kύπρος 
Pfizer Ελλάς Α.Ε. (Cyprus Branch)  
Τηλ: +357 22 817690 

Sverige  
Pfizer Innovations AB 
Tel: +46 (0)8 550 520 00 

Latvija 
Pfizer Luxembourg SARL filiāle Latvijā 
Tel.: + 371 670 35 775 

United Kingdom 
Pfizer Limited 
Tel: +44 (0) 1304 616161 

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

 
 


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