BEMFOLA 75UI / 0.125ml injection for pre-filled pen medication leaflet

Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen

Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen

Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen

Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen

Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen

Each mL of the solution contains 600 IU (equivalent to 44 micrograms) of follitropin alfa*.

Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen:

Each pre-filled pen delivers 75 IU (equivalent to 5.5 micrograms) in 0.125 mL.

Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen:

Each pre-filled pen delivers 150 IU (equivalent to 11 micrograms) in 0.25 mL.

Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen:

Each pre-filled pen delivers 225 IU (equivalent to 16.5 micrograms) in 0.375 mL.

Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen:

Each pre-filled pen delivers 300 IU (equivalent to 22 micrograms) in 0.5 mL.

Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen:

Each pre-filled pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 mL.

* recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary(CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Solution for injection (injection).

Clear colourless solution.

The pH of the solution is 6.7 to 7.3.

In adult women

* Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive totreatment with clomiphene citrate.

* Stimulation of multifollicular development in women undergoing superovulation for assistedreproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopiantransfer and zygote intra-fallopian transfer.

* Follitropin alfa in association with a luteinising hormone (LH) preparation is indicated for thestimulation of follicular development in women with severe LH and FSH deficiency.

In adult men

* Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenitalor acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotropin(hCG) therapy.

Treatment with follitropin alfa should be initiated under the supervision of a physician experienced inthe treatment of fertility disorders.

Patients must be provided with the correct number of pens for their treatment course and educated touse the proper injection techniques.

The dose recommendations given for follitropin alfa are those in use for urinary FSH. Clinicalassessment of follitropin alfa indicates that its daily doses, regimens of administration and treatmentmonitoring procedures should not be different from those currently used for urinary FSH-containingmedicinal products. It is advised to adhere to the recommended starting doses indicated below.

Comparative clinical studies have shown that on average patients require a lower cumulative dose andshorter treatment duration with follitropin alfa compared with urinary FSH. Therefore, it is consideredappropriate to give a lower total dose of follitropin alfa than generally used for urinary FSH, not onlyin order to optimise follicular development but also to minimise the risk of unwanted ovarianhyperstimulation (see section 5.1).

Women with anovulation (including polycystic ovarian syndrome)

Follitropin alfa may be given as a course of daily injections. In menstruating women treatment shouldcommence within the first 7 days of the menstrual cycle.

A commonly used regimen commences at 75 to 150 IU FSH daily and is increased preferably by 37.5or 75 IU at 7 or preferably 14-day intervals if necessary, to obtain an adequate, but not excessive,response. Treatment should be tailored to the individual patient’s response as assessed by measuringfollicle size by ultrasound and/or estrogen secretion. The maximal daily dose is usually not higher than225 IU FSH. If a patient fails to respond adequately after 4 weeks of treatment, that cycle should beabandoned and the patient should undergo further evaluation after which she may recommencetreatment at a higher starting dose than in the abandoned cycle.

When an optimal response is obtained, a single injection of 250 micrograms recombinant humanchoriogonadotropin alfa (r-hCG) or 5 000 IU up to 10 000 IU hCG should be administered 24 to48 hours after the last follitropin alfa injection. The patient is recommended to have coitus on the dayof, and the day following hCG administration. Alternatively, intrauterine insemination may beperformed.

If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4.4).

Treatment should recommence in the next cycle at a dose lower than that of the previous cycle.

Women undergoing ovarian stimulation for multiple follicular development prior to in vitrofertilisation or other assisted reproductive technologies

A commonly used regimen for superovulation involves the administration of 150 to 225 IU offollitropin alfa daily commencing on days 2 or 3 of the cycle. Treatment is continued until adequatefollicular development has been achieved (as assessed by monitoring of serum estrogen concentrationsand/or ultrasound examination), with the dose adjusted according to the patient's response, to usuallynot higher than 450 IU daily. In general adequate follicular development is achieved on average by thetenth day of treatment (range 5 to 20 days).

A single injection of 250 micrograms r-hCG or 5 000 IU up to 10 000 IU hCG is administered 24 to48 hours after the last follitropin alfa injection to induce final follicular maturation.

Down-regulation with a gonadotropin-releasing hormone (GnRH) agonist or antagonist is nowcommonly used in order to suppress the endogenous LH surge and to control tonic levels of LH. In acommonly used protocol, follitropin alfa is started approximately 2 weeks after the start of agonisttreatment, both being continued until adequate follicular development is achieved. For example,following two weeks of treatment with an agonist, 150 to 225 IU follitropin alfa are administered forthe first 7 days. The dose is then adjusted according to the ovarian response.

Overall experience with IVF indicates that in general the treatment success rate remains stable duringthe first four attempts and gradually declines thereafter.

Women with severe LH and FSH deficiency

In LH and FSH deficient women, the objective of follitropin alfa therapy in association with aluteinising hormone (LH) preparation is to promote follicular development followed by finalmaturation after the administration of human chorionic gonadotropin (hCG). Follitropin alfa should begiven as a course of daily injections simultaneously with lutropin alfa. If the patient is amenorrhoeicand has low endogenous estrogen secretion, treatment can commence at any time.

A recommended regimen commences at 75 IU of lutropin alfa daily with 75 to 150 IU FSH. Treatmentshould be tailored to the individual patient's response as assessed by measuring follicle size byultrasound and estrogen response.

If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7 to 14-dayintervals and preferably by 37.5 to 75 IU increments. It may be acceptable to extend the duration ofstimulation in any one cycle to up to 5 weeks.

When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5 000 IU up to10 000 IU hCG should be administered 24 to 48 hours after the last follitropin alfa and lutropin alfainjections. The patient is recommended to have coitus on the day of, and on the day following hCGadministration. Alternatively, intrauterine insemination or another medically assisted reproductionprocedure may be performed based on the physician’s judgment of the clinical case.

Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG)after ovulation may lead to premature failure of the corpus luteum.

If an excessive response is obtained, treatment should be stopped and hCG withheld. Treatment shouldrecommence in the next cycle at a dose of FSH lower than that of the previous cycle (see section 4.4).

Men with hypogonadotrophic hypogonadism

Follitropin alfa should be given at a dose of 150 IU three times a week, concomitantly with hCG, for aminimum of 4 months. If after this period, the patient has not responded, the combination treatmentmay be continued; current clinical experience indicates that treatment for at least 18 months may benecessary to achieve spermatogenesis.

There is no relevant use of follitropin alfa in the elderly population. Safety and efficacy of follitropinalfa in elderly patients have not been established.

Safety, efficacy and pharmacokinetics of follitropin alfa in patients with renal or hepatic impairmenthave not been established.

There is no relevant use of follitropin alfa in the paediatric population.

Bemfola is intended for subcutaneous use. The injection should be given at the same time each day.

The first injection of Bemfola should be performed under direct medical supervision. Self-administration of Bemfola should only be performed by patients who are well motivated, adequatelytrained and have access to expert advice.

The injection site should be alternated daily.

As the Bemfola pre-filled pen with the single-dose cartridge is intended for only one injection, clearinstructions should be provided to the patients to avoid misuse of the single dose presentation.

For instructions on the administration with the pre-filled pen, see section 6.6 and the package leaflet.

* hypersensitivity to the active substance or to any of the excipients listed in section 6.1;

* tumours of the hypothalamus or pituitary gland;

* ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknownorigin;

* gynaecological haemorrhages of unknown origin;

* ovarian, uterine or mammary carcinoma.

Follitropin alfa must not be used when an effective response cannot be obtained, such as in cases of:

* primary ovarian failure;

* malformations of sexual organs incompatible with pregnancy;

* fibroid tumours of the uterus incompatible with pregnancy;

* primary testicular insufficiency.

In order to improve the traceability of biological medicinal products, the name and the batch numberof the administered product should be clearly recorded.

Follitropin alfa is a potent gonadotrophic substance capable of causing mild to severe adversereactions and should only be used by physicians who are thoroughly familiar with infertility problemsand their management.

Gonadotropin therapy requires a certain time commitment by physicians and supportive health careprofessionals, as well as the availability of appropriate monitoring facilities. In women, safe andeffective use of follitropin alfa calls for monitoring of the ovarian response with ultrasound, alone orpreferably in combination with measurement of serum estradiol levels, on a regular basis. There maybe a degree of inter-patient variability in response to FSH administration, with a poor response to FSHin some patients and exaggerated response in others. The lowest effective dose in relation to thetreatment objective should be used in both men and women.

Porphyria

Patients with porphyria or a family history of porphyria should be closely monitored during treatmentwith follitropin alfa. Deterioration or a first appearance of this condition may require cessation oftreatment.

Treatment in women

Before starting treatment, the couple's infertility should be assessed as appropriate and putativecontraindications for pregnancy evaluated. In particular, patients should be evaluated forhypothyroidism, adrenocortical deficiency, hyperprolactinemia and appropriate specific treatmentgiven.

Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or

ART procedures, may experience ovarian enlargement or develop hyperstimulation. Adherence to therecommended follitropin alfa dose and regimen of administration, and careful monitoring of therapywill minimise the incidence of such events. For accurate interpretation of the indices of follicledevelopment and maturation, the physician should be experienced in the interpretation of the relevanttests.

In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administeredwith lutropin alfa. If an FSH dose increase is deemed appropriate, dose adaptation should preferablybe at 7- to 14-day intervals and preferably with 37.5 to 75 IU increments.

No direct comparison of follitropin alfa/LH versus human menopausal gonadotropin (hMG) has beenperformed. Comparison with historical data suggests that the ovulation rate obtained with follitropinalfa/LH is similar to that obtained with hMG.

Ovarian Hyperstimulation Syndrome (OHSS)

A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It ismore commonly seen in women with polycystic ovarian syndrome and usually regresses withouttreatment.

In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself withincreasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids, andan increase in vascular permeability which can result in an accumulation of fluid in the peritoneal,pleural and, rarely, in the pericardial cavities.

The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominaldistension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptomsincluding nausea, vomiting and diarrhoea. Clinical evaluation may reveal hypovolaemia,haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions,hydrothorax, or acute pulmonary distress. Very rarely, severe OHSS may be complicated by ovariantorsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardialinfarction.

Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovariansyndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiollevels and previous episodes of OHSS, large number of developing ovarian follicles and large numberof oocytes retrieved in assisted reproductive technology (ART) cycles.

Adherence to recommended follitropin alfa dose and regimen of administration can minimise the riskof ovarian hyperstimulation (see sections 4.2 and 4.8). Monitoring of stimulation cycles by ultrasoundscans as well as estradiol measurements are recommended to early identify risk factors.

There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome maybe more severe and more protracted if pregnancy occurs. Therefore, if signs of ovarianhyperstimulation occur such as a serum estradiol level > 5 500 pg/mL or > 20 200 pmol/L and/or≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrainfrom coitus or to use barrier contraceptive methods for at least 4 days. OHSS may progress rapidly(within 24 hours) or over several days to become a serious medical event. It most often occurs afterhormonal treatment has been discontinued and reaches its maximum at about seven to ten daysfollowing treatment. Therefore, patients should be followed for at least two weeks after hCGadministration.

In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.

Mild or moderate OHSS usually resolves spontaneously. If severe OHSS occurs, it is recommendedthat gonadotropin treatment be stopped if still ongoing, and that the patient be hospitalised, andappropriate therapy be started.

Multiple pregnancy

In patients undergoing ovulation induction, the incidence of a multiple pregnancy is increasedcompared with natural conception. The majority of multiple conceptions are twins. Multiplepregnancy, especially of high order, carries an increased risk of adverse maternal and perinataloutcomes.

To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.

In patients undergoing ART procedures the risk of a multiple pregnancy is related mainly to thenumber of embryos replaced, their quality and the patient age.

The patients should be advised of the potential risk of multiple births before starting treatment.

Pregnancy loss

The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoingstimulation of follicular growth for ovulation induction or ART than following natural conception.

Ectopic pregnancy

Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy isobtained by spontaneous conception or with fertility treatments. The prevalence of ectopic pregnancyafter ART was reported to be higher than in the general population.

Reproductive system neoplasms

There have been reports of ovarian and other reproductive system neoplasms, both benign andmalignant, in women who have undergone multiple treatment regimens for infertility treatment. It isnot yet established whether or not treatment with gonadotropins increases the risk of these tumours ininfertile women.

Congenital malformation

The prevalence of congenital malformations after ART may be slightly higher than after spontaneousconceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age,sperm characteristics) and multiple pregnancies.

In women with recent or ongoing thromboembolic disease or women with generally recognised riskfactors for thromboembolic events, such as personal or family history, treatment with gonadotropinsmay further increase the risk for aggravation or occurrence of such events. In these women, thebenefits of gonadotropin administration need to be weighed against the risks. It should be notedhowever that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.

Treatment in men

Elevated endogenous FSH levels are indicative of primary testicular failure. Such patients areunresponsive to follitropin alfa/hCG therapy. Follitropin alfa should not be used when an effectiveresponse cannot be obtained.

Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of theassessment of the response.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially“sodium-free”.

Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation(e.g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a

GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitropin alfaneeded to elicit an adequate ovarian response. No other clinically significant medicinal productinteraction has been reported during follitropin alfa therapy.

There is no indication for use of follitropin alfa during pregnancy. Data on a limited number ofexposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or feto/neonataltoxicity of follitropin alfa.

No teratogenic effect has been observed in animal studies (see section 5.3). In case of exposure duringpregnancy, clinical data are not sufficient to exclude a teratogenic effect of follitropin alfa.

Follitropin alfa is not indicated during breast-feeding.

Follitropin alfa is indicated for use in infertility (see section 4.1).

Follitropin alfa has no or negligible influence on the ability to drive and use machines.

The most commonly reported adverse reactions are headache, ovarian cysts and local injection sitereactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection).

Mild or moderate ovarian hyperstimulation syndrome (OHSS) has been commonly reported andshould be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (seesection 4.4).

Thromboembolism may occur very rarely (see section 4.4).

List of adverse reactions

The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10),common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), veryrare (< 1/10,000).

Treatment in women

Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions andshock

Very common: Headache

Very rare: Thromboembolism (both in association with and separate from OHSS)

Very rare: Exacerbation or aggravation of asthma

Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting,diarrhoea

Very common: Ovarian cysts

Common: Mild or moderate OHSS (including associated symptomatology)

Uncommon: Severe OHSS (including associated symptomatology) (see section 4.4)

Rare: Complication of severe OHSS

Very common: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritationat the site of injection)

Treatment in men

Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions andshock

Very rare: Exacerbation or aggravation of asthma

Common: Acne

Common: Gynaecomastia, varicocele

Very common: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritationat the site of injection)

Common: Weight gain

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Itallows continued monitoring of the benefit/risk balance of the medicinal product. Healthcareprofessionals are asked to report any suspected adverse reactions via the national reporting systemlisted in Appendix V.

The effects of an overdose of follitropin alfa are unknown, nevertheless, there is a possibility that

OHSS may occur (see section 4.4).

Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins,

ATC code: G03GA05.

Bemfola is a biosimilar medicinal product. Detailed information is available on the website of the

European Medicines Agency http://www.ema.europa.eu.

Follicle stimulating hormone (FSH) and luteinising hormone (LH) are secreted from the anteriorpituitary gland in response to GnRH and play a complementary role in follicle development andovulation. FSH stimulates the development of ovarian follicles, while LH action is involved in follicledevelopment, steroidogenesis and maturation.

Inhibin and estradiol (E2) levels are raised after administration of r-hFSH, with subsequent inductionof follicular development. Inhibin serum level increase is rapid and can be observed as early as thethird day of r-hFSH administration, while E2 levels take more time, and an increase is observed onlyfrom the fourth day of treatment. Total follicular volume starts to increase after 4 to 5 days of r-hFSHdaily dosing, and, depending on patient response, the maximum effect is reached after about 10 daysfrom the start of r-hFSH administration.

Clinical efficacy and safety in women

In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum

LH level < 1.2 IU/L as measured in a central laboratory. However, it should be taken into account thatthere are variations between LH measurements performed in different laboratories.

In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table below) andin ovulation induction, follitropin alfa was more potent than urinary FSH in terms of a lower total doseand a shorter treatment period needed to trigger follicular maturation.

In ART, follitropin alfa at a lower total dose and shorter treatment period than urinary FSH, resulted ina higher number of oocytes retrieved when compared to urinary FSH.

Table: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety offollitropin alfa with urinary FSH in assisted reproduction technologies)follitropin alfa urinary FSH(n = 130) (n = 116)

Number of oocytes retrieved 11.0 ± 5.9 8.8 ± 4.8

Days of FSH stimulation required 11.7 ± 1.9 14.5 ± 3.3

Total dose of FSH required (number of FSH 75 IUampoules) 27.6 ± 10.2 40.7 ± 13.6

Need to increase the dose (%) 56.2 85.3

Differences between the 2 groups were statistically significant (p< 0.05) for all criteria listed.

Clinical efficacy and safety in men

In men deficient in FSH, follitropin alfa administered concomitantly with hCG for at least 4 monthsinduces spermatogenesis.

There is no pharmacokinetic interaction between follitropin alfa and lutropin alfa when administeredsimultaneously.

Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space withan initial half-life of around 2 hours and eliminated from the body with a terminal half-life of 14 to17 hours. The steady state volume of distribution is in the range of 9 to 11 L.

Following subcutaneous administration, the absolute bioavailability is 66% and the apparent terminalhalf-life is in the range of 24 to 59 hours. Dose proportionality after subcutaneous administration wasdemonstrated up to 900 IU. Following repeated administration, follitropin alfa accumulates 3-foldachieving a steady-state within 3 to 4 days.

Total clearance is 0.6 L/h and about 12% of the follitropin alfa dose is excreted in the urine.

Non-clinical data reveal no special hazard for humans based on conventional studies of single andrepeated dose toxicity and genotoxicity in addition to those already stated in the other sections of this

SmPC.

Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa(≥ 40 IU/kg/day) for extended periods, through reduced fecundity.

Given in high doses (≥ 5 IU/kg/day) follitropin alfa caused a decrease in the number of viable foetuseswithout being teratogenic, and dystocia similar to that observed with urinary menopausal gonadotropin(hMG). However, since follitropin alfa is not indicated in pregnancy, these data are of limited clinicalrelevance.

Poloxamer 188

Sucrose

Methionine

Disodium phosphate dihydrate

Sodium dihydrogen phosphate dihydrate

Phosphoric acid

Water for injections

Not applicable.

3 years

Once opened, the medicinal product should be injected immediately.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Before opening and within its shelf life, the medicinal product may be removed from the refrigerator,and without being refrigerated again, may be stored for up to 3 months at or below 25°C. Themedicinal product must be discarded if it has not been used after 3 months.

Store in the original package in order to protect from light.

1.5 mL cartridge (type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp capwith a rubber inlay, assembled in a pre-filled pen.

Bemfola 75 IU/0.125 mL:

Each cartridge contains 0.125 mL solution for injection.

Bemfola 150 IU/0.25 mL:

Each cartridge contains 0.25 mL solution for injection.

Bemfola 225 IU/0.375 mL:

Each cartridge contains 0.375 mL solution for injection.

Bemfola 300 IU/0.50 mL:

Each cartridge contains 0.5 mL solution for injection.

Bemfola 450 IU/0.75 mL:

Each cartridge contains 0.75 mL solution for injection.

Pack sizes of 1, 5 and 10 pre-filled pens including one disposable needle and alcohol swab per pen.

One needle and one alcohol swab to be used with the pen for administration.

Not all pack sizes may be marketed.

The solution should not be administered if it contains particles or is not clear.

Bemfola pre-filled pen is not designed to allow the cartridge to be removed.

Discard used pen and needle immediately after injection.

Any unused medicinal product or waste material should be disposed of in accordance with localrequirements.

For instructions on the administration with the pre-filled pen, see the package leaflet.

Gedeon Richter Plc.

Gyömrői út 19-21.1103 Budapest

Hungary

Bemfola 75 IU/0.125 mL:

EU/1/13/909/001

EU/1/13/909/006

EU/1/13/909/007

Bemfola 150 IU/0.25 mL:

EU/1/13/909/002

EU/1/13/909/008

EU/1/13/909/009

Bemfola 225 IU/0.375 mL:

EU/1/13/909/003

EU/1/13/909/010

EU/1/13/909/011

Bemfola 300 IU/0.50 mL:

EU/1/13/909/004

EU/1/13/909/012

EU/1/13/909/013

Bemfola 450 IU/0.75 mL:

EU/1/13/909/005

EU/1/13/909/014

EU/1/13/909/015

Date of first authorisation: 27/03/2014

Date of latest renewal:

Detailed information on this medicinal product is available on the website of the European Medicines

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