PUREGON 900UI / 1.08ml solution for injection medication leaflet

Puregon 150 IU/0.18 mL solution for injection

Puregon 300 IU/0.36 mL solution for injection

Puregon 600 IU/0.72 mL solution for injection

Puregon 900 IU/1.08 mL solution for injection

Puregon 150 IU/0.18 mL solution for injection

One cartridge contains a net total dose of 150 IU recombinant follicle-stimulating hormone (FSH) in0.18 mL aqueous solution. The solution for injection contains the active substance follitropin beta,produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein/mL (specificin vivo bioactivity equal to approximately 10,000 IU FSH/mg protein).

Puregon 300 IU/0.36 mL solution for injection

One cartridge contains a net total dose of 300 IU recombinant follicle-stimulating hormone (FSH) in0.36 mL aqueous solution. The solution for injection contains the active substance follitropin beta,produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein/mL (specificin vivo bioactivity equal to approximately 10,000 IU FSH/mg protein).

Puregon 600 IU/0.72 mL solution for injection

One cartridge contains a net total dose of 600 IU recombinant follicle-stimulating hormone (FSH) in0.72 mL aqueous solution. The solution for injection contains the active substance follitropin beta,produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein/mL (specificin vivo bioactivity equal to approximately 10,000 IU FSH/mg protein).

Puregon 900 IU/1.08 mL solution for injection

One cartridge contains a net total dose of 900 IU recombinant follicle-stimulating hormone (FSH) in1.08 mL aqueous solution. The solution for injection contains the active substance follitropin beta,produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein/mL (specificin vivo bioactivity equal to approximately 10,000 IU FSH/mg protein).

This medicinal product contains 10 mg of benzyl alcohol per mL.

For the full list of excipients, see section 6.1.

Solution for injection (injection).

Clear and colourless solution.

In cartridges, designed to be used in conjunction with a pen injector.

In adult females:

Puregon is indicated for the treatment of female infertility in the following clinical situations:

* Anovulation (including polycystic ovarian syndrome, PCOS) in women who have beenunresponsive to treatment with clomifene citrate.

* Controlled ovarian hyperstimulation to induce the development of multiple follicles inmedically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET),gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].

In adult males:

* Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

Treatment with Puregon should be initiated under the supervision of a physician experienced in thetreatment of fertility problems.

The first injection with Puregon should be performed under direct medical supervision.

Dosage in the female

There are great inter- and intra-individual variations in the response of the ovaries to exogenousgonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should,therefore, be adjusted individually depending on the ovarian response. This requires ultrasoundassessment of follicular development. The concurrent determination of serum oestradiol levels mayalso be useful.

When using the pen-injector, it should be realised that the pen is a precision device which accuratelydelivers the dose to which it is set. It was shown that on average an 18% higher amount of FSH isgiven with the pen compared with a conventional syringe. This may be of particular relevance whenswitching between the pen-injector and a conventional syringe within one treatment cycle. Especiallywhen switching from a syringe to the pen, small dose adjustments may be needed to prevent too high adose being given.

Based on the results of comparative clinical studies, it is considered appropriate to give a lower totaldosage of Puregon over a shorter treatment period than generally used for urinary FSH, not only inorder to optimise follicular development but also to reduce the risk of unwanted ovarianhyperstimulation (see section 5.1).

Clinical experience with Puregon is based on up to three treatment cycles in both indications. Overallexperience with IVF indicates that in general the treatment success rate remains stable during the firstfour attempts and gradually declines thereafter.

* Anovulation

A sequential treatment scheme is recommended starting with daily administration of 50 IU

Puregon. The starting dose is maintained for at least seven days. If there is no ovarian response,the daily dose is then gradually increased until follicle growth and/or plasma oestradiol levelsindicate an adequate pharmacodynamic response. A daily increase of oestradiol levels of40-100% is considered to be optimal. The daily dose is then maintained until pre-ovulatoryconditions are reached. Pre-ovulatory conditions are reached when there is ultrasonographicevidence of a dominant follicle of at least 18 mm in diameter and/or when plasma oestradiollevels of 300-900 picograms/mL (1,000-3,000 pmol/L) are attained. Usually, 7 to 14 days oftreatment is sufficient to reach this state. The administration of Puregon is then discontinued andovulation can be induced by administering human chorionic gonadotrophin (hCG).

If the number of responding follicles is too high or oestradiol levels increase too rapidly, i.e.

more than a daily doubling for oestradiol for two or three consecutive days, the daily doseshould be decreased.

Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory folliclesexceeding 14 mm carry the risk of multiple gestations. In that case hCG should be withheld andpregnancy should be avoided to prevent multiple gestations.

* Controlled ovarian hyperstimulation in medically assisted reproduction programs

Various stimulation protocols are applied. A starting dose of 100-225 IU is recommended for atleast the first four days. Thereafter, the dose may be adjusted individually, based upon ovarianresponse. In clinical studies it was shown that maintenance dosages ranging from 75-375 IU forsix to twelve days are sufficient, although longer treatment may be necessary.

Puregon can be given either alone, or, to prevent premature luteinisation, in combination with a

GnRH agonist or antagonist. When using a GnRH agonist, a higher total treatment dose of

Puregon may be required to achieve an adequate follicular response.

Ovarian response is monitored by ultrasound assessment. The concurrent determination ofserum oestradiol levels may also be useful. When ultrasound assessment indicates the presenceof at least three follicles of 16-20 mm, and there is evidence of a good oestradiol response(plasma levels of about 300-400 picograms/mL (1,000-1,300 pmol/L) for each follicle with adiameter greater than 18 mm), the final phase of maturation of the follicles is induced byadministration of hCG. Oocyte retrieval is performed 34-35 hours later.

Dosage in the male

Puregon should be given at a dosage of 450 IU/week, preferably divided in 3 dosages of 150 IU,concomitantly with hCG. Treatment with Puregon and hCG should be continued for at least 3 to4 months before any improvement in spermatogenesis can be expected. To assess the response, semenanalysis is recommended 4 to 6 months after the beginning of treatment. If a patient has not respondedafter this period, the combination therapy may be continued; current clinical experience indicates thattreatment for up to 18 months or longer may be necessary to achieve spermatogenesis.

There is no relevant use of Puregon in the paediatric population for the approved indication.

Puregon solution for injection in cartridges has been developed for use in the Puregon Pen and shouldbe administered subcutaneously. The injection site should be alternated to prevent lipoatrophy.

Using the pen, injection of Puregon can be carried out by the patient, provided that proper instructionsare given by the physician. Before using the pen, the instructions for use must be read carefully.

For males and females

* Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

* Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus.

* Primary gonadal failure.

Additionally for females

* Undiagnosed vaginal bleeding.

* Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS).

* Malformations of the reproductive organs incompatible with pregnancy.

* Fibroid tumours of the uterus incompatible with pregnancy.

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

Antibiotic hypersensitivity reactions

* Puregon may contain traces of streptomycin and/or neomycin. These antibiotics may causehypersensitivity reactions in susceptible persons.

Infertility evaluation before starting treatment

* Before starting treatment, the couple's infertility should be assessed as appropriate. In particular,patients should be evaluated for hypothyroidism, adrenocortical insufficiency,hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatmentgiven.

In females

Ovarian Hyperstimulation Syndrome (OHSS)

OHSS is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs andsymptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderateenlargement of ovaries and ovarian cysts. Severe OHSS may be life-threatening. Clinical signs andsymptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion,hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain. In rare instances,venous or arterial thromboembolism may occur in association with OHSS. Transient liver function testabnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsyhave also been reported in association with OHSS.

OHSS may be caused by administration of human Chorionic Gonadotropin (hCG) and by pregnancy(endogenous hCG). Early OHSS usually occurs within 10 days after hCG administration and may beassociated with an excessive ovarian response to gonadotropin stimulation. Late OHSS occurs morethan 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy.

Because of the risk of developing OHSS, patients should be monitored for at least two weeks afterhCG administration.

Women with known risk factors for a high ovarian response may be especially prone to thedevelopment of OHSS during or following treatment with Puregon. For women having their first cycleof ovarian stimulation, for whom risk factors are only partially known, close observation for earlysigns and symptoms of OHSS is recommended.

Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive

Technology (ART). Adherence to the recommended Puregon dose and treatment regimen and carefulmonitoring of ovarian response is important to reduce the risk of OHSS. To monitor the risk of OHSS,ultrasonographic assessments of follicular development should be performed prior to treatment and atregular intervals during treatment; the concurrent determination of serum oestradiol levels may also beuseful. In ART there is an increased risk of OHSS with 18 or more follicles of 11 mm or more indiameter.

If OHSS develops, standard and appropriate management of OHSS should be implemented andfollowed.

Multiple Pregnancy

Multiple pregnancies and births have been reported for all gonadotropin treatments, including

Puregon. Multiple gestation, especially high order, carries an increased risk of adverse maternal(pregnancy and delivery complications) and perinatal (low birth weight) outcomes. For anovulatorywomen undergoing ovulation induction, monitoring follicular development with transvaginalultrasonography may aid in determining whether or not to continue the cycle in order to reduce therisk of multiple pregnancies. The concurrent determination of serum oestradiol levels may also beuseful. The patients should be advised of the potential risks of multiple births before startingtreatment.

In women undergoing Assisted Reproduction Technologies (ART) procedures, the risk of a multiplepregnancy is mainly related to the number of embryos transferred. When used for an ovulationinduction cycle, appropriate FSH dose adjustment(s) should prevent multiple follicle development.

Ectopic Pregnancy

Infertile women undergoing ART have an increased incidence of ectopic pregnancies. Earlyultrasound confirmation that a pregnancy is intrauterine is therefore important.

Spontaneous Abortion

Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in thenormal population.

Vascular Complications

Thromboembolic events, both in association with and separate from OHSS, have been reportedfollowing treatment with gonadotropins, including Puregon. Intravascular thrombosis, which mayoriginate in venous or arterial vessels, can result in reduced blood flow to vital organs or theextremities. In women with generally recognised risk factors for thromboembolic events, such as apersonal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including

Puregon, may further increase this risk. In these women the benefits of gonadotropin administration,including Puregon, need to be weighed against the risks. It should be noted, however, that pregnancyitself also carries an increased risk of thrombosis.

Congenital Malformations

The incidence 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 gestations.

Ovarian Torsion

Ovarian torsion has been reported after treatment with gonadotropins, including Puregon. Ovariantorsion may be associated with other risk factors such as OHSS, pregnancy, previous abdominalsurgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries.

Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediatedetorsion.

Ovarian and Other 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 established whether or not treatment with gonadotrophins increases the risk of these tumours ininfertile women.

Other Medical Conditions

Medical conditions that contraindicate pregnancy should also be evaluated before starting treatmentwith Puregon.

In males

Primary Testicular Failure

Elevated endogenous FSH levels in men are indicative of primary testicular failure. Such patients areunresponsive to Puregon/hCG therapy.

Benzyl alcohol

Benzyl alcohol may cause anaphylactoid reactions.

Large amounts of benzyl alcohol may cause metabolic acidosis. Special precautions should be takenwhen prescribing Puregon to pregnant or breast-feeding women and patients with liver or kidneydisease.

This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to sayessentially ‘sodium-free’.

Concomitant use of Puregon and clomifene citrate may enhance the follicular response. After pituitarydesensitisation induced by a GnRH agonist, a higher dose of Puregon may be necessary to achieve anadequate follicular response.

Puregon is used in the treatment of women undergoing ovarian induction or controlled ovarianhyperstimulation in assisted reproduction programmes. In males Puregon is used in the treatment ofdeficient spermatogenesis due to hypogonadotrophic hypogonadism. For posology and method ofadministration, see section 4.2.

The use of Puregon during pregnancy is not indicated. In case of inadvertent exposure duringpregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.

However, to date, no particular malformative effect has been reported. No teratogenic effect has beenobserved in animal studies.

There is no information available from clinical or animal studies on the excretion of follitropin beta inmilk. It is unlikely that follitropin beta is excreted in human milk due to its high molecular weight. Iffollitropin beta would be excreted in human milk, it would be degraded in the gastrointestinal tract ofthe child. Follitropin beta may affect milk production.

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

Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at thesite of injection (3% of all patients treated). The majority of these local reactions are mild and transientin nature. Generalised hypersensitivity reactions have been observed uncommonly (approximately0.2% of all patients treated with follitropin beta). Cases of anaphylactic reactions (including thoserequiring hospitalisation) have been reported in the post-marketing setting.

Treatment of females:

In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptomsrelated to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4). Adversereactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/ordistension, breast complaints and ovarian enlargement.

The table below lists the adverse reactions with follitropin beta reported in clinical trials and post-marketing surveillance in females, according to system organ class and frequency; common (≥ 1/100to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from availabledata).

SOC Frequency Adverse reaction

Immune system disorders Not known Anaphylactic reactions

Nervous system disorders Common Headache

Gastrointestinal disorders Common Abdominal distension

Abdominal pain

Uncommon Abdominal discomfort

Nausea

Reproductive system and breast Common OHSSdisorders Pelvic pain

Uncommon Breast complaints1

Metrorrhagia

Ovarian cyst

Ovarian enlargement

Ovarian torsion

Uterine enlargement

Vaginal haemorrhage

General disorders and Common Injection site reaction2administration site conditions

Uncommon Generalised hypersensitivityreaction31. Breast complaints include tenderness, pain and/or engorgement and nipple pain.

2. Local reactions at the site of injection include: bruising, pain, redness, swelling and itching.

3. Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus.

In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported. These areconsidered to be related to ART or subsequent pregnancy.

In rare instances, thromboembolism has been associated with follitropin beta /hCG therapy as withother gonadotrophins.

Treatment of males:

The table below lists the adverse reactions with follitropin beta reported in a clinical trial in males(30 patients dosed) and post-marketing surveillance, according to system organ class and frequency;common (≥ 1/100 to < 1/10) and not known (cannot be estimated from available data).

SOC Frequency1 Adverse reaction

Immune system disorders Not known Anaphylactic reactions

Nervous system disorders Common Headache

Skin and subcutaneous tissue Common Acnedisorders Rash

Reproductive system and breast Common Epididymal cystdisorders Gynaecomastia

General disorders and Common Injection site reaction2administration site conditions1. Adverse reactions that are reported only once are listed as common because a single report raises thefrequency above 1%.

2. Local reactions at the site of injection include induration and pain.

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.

No data on acute toxicity of Puregon in humans is available, but the acute toxicity of Puregon and ofurinary gonadotrophin preparations in animal studies has been shown to be very low. Too high adosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).

Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotrophins;

ATC code: G03G A06.

Puregon contains a recombinant FSH. This is produced by recombinant DNA technology, using a

Chinese hamster ovary cell line transfected with the human FSH subunit genes. The primary aminoacid sequence is identical to that of natural human FSH. Small differences in the carbohydrate chainstructure are known to exist.

Mechanism of Action

FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production. Inthe female the level of FSH is critical for the onset and duration of follicular development, andconsequently for the timing and number of follicles reaching maturity. Puregon can thus be used tostimulate follicular development and steroid production in selected cases of disturbed gonadalfunction. Furthermore Puregon can be used to promote multiple follicular development in medicallyassisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. Treatment with Puregon isgenerally followed by administration of hCG to induce the final phase of follicle maturation,resumption of meiosis and rupture of the follicle.

Clinical Efficacy and Safety

In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarianstimulation in women participating in an assisted reproduction technology (ART) program and forovulation induction (see tables 1 and 2 below), Puregon was more potent than urinary FSH in terms ofa lower total dose and a shorter treatment period needed to trigger follicular maturation.

For controlled ovarian stimulation, Puregon resulted in a higher number of oocytes retrieved at a lowertotal dose and with a shorter treatment period, when compared to urinary FSH.

Table 1: Results of study 37,608 (randomized, group comparative clinical study comparing safety andefficacy of Puregon with urinary FSH in controlled ovarian stimulation).

Puregon u-FSH(n = 546) (n = 361)

Mean no. of oocytes retrieved 10.84* 8.95

Mean total dose (no. of 75 IU ampoules) 28.5* 31.8

Mean duration of FSH stimulation (days) 10.7* 11.3

* Differences between the 2 groups were statistically significant (p0.05).

For ovulation induction, Puregon resulted in a lower median total dose and shorter median duration oftreatment when compared to urinary FSH.

Table 2: Results of study 37,609 (randomized, group comparative clinical study comparing safety andefficacy of Puregon with urinary FSH in ovulation induction).

Puregon u-FSH(n = 105) (n = 66)

Mean no. of follicles ≥ 12 mm 3.6* 2.6≥ 15 mm 2.0 1.7≥ 18 mm 1.1 0.9a

Median total dose (IU) 750* 1,035a

Median duration of treatment (days) 10.0* 13.0

* Differences between the 2 groups were statistically significant (p0.05).a

Restricted to women with ovulation induced (Puregon, n = 76; u-FSH, n = 42).

After subcutaneous administration of Puregon, maximum concentration of FSH is reached withinabout 12 hours. Due to the sustained release from the injection site and the elimination half-life ofabout 40 hours (ranging from 12 to 70 hours), FSH levels remain increased for 24-48 hours. Due to therelatively long elimination half-life, repeated administration of the same dose will lead to plasmaconcentrations of FSH that are approximately 1.5-2.5 times higher than after single-doseadministration. This increase enables therapeutic FSH concentrations to be reached.

The absolute bioavailability of subcutaneously administered Puregon is approximately 77%.

Distribution, biotransformation and elimination

Recombinant FSH is biochemically very similar to urinary human FSH and is distributed,metabolised, and excreted in the same way.

Single-dose administration of Puregon to rats induced no toxicologically significant effects. Inrepeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal humandose, Puregon induced no toxicologically significant effects. Puregon showed no mutagenic potentialin the Ames test and in the in vitro chromosome aberration test with human lymphocytes.

Puregon solution for injection contains:

Sucrose

Sodium citrate

L-methionine

Polysorbate 20

Benzyl alcohol

Water for injections.

The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinalproducts.

3 years.

Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximumof 28 days.

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Keep the cartridge in the outer carton.

For patient convenience, Puregon may be stored at or below 25ºC by the patient for a single period ofnot more than 3 months.

For storage conditions after first opening of the medicinal product, see section 6.3.

Puregon 150 IU/0.18 mL solution for injection0.18 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminiumcrimp-cap with a rubber inlay.

Pack of 1 cartridge and 3 needles to be used with the Puregon Pen.

Cartridges contain a minimum of 225 IU FSH activity in 0.270 mL aqueous solution, which issufficient for a net total dose of 150 IU.

Puregon 300 IU/0.36 mL solution for injection0.36 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminiumcrimp-cap with a rubber inlay.

Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.

Cartridges contain a minimum of 400 IU FSH activity in 0.480 mL aqueous solution, which issufficient for a net total dose of 300 IU.

Puregon 600 IU/0.72 mL solution for injection0.72 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminiumcrimp-cap with a rubber inlay.

Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.

Cartridges contain a minimum of 700 IU FSH activity in 0.840 mL aqueous solution, which issufficient for a net total dose of 600 IU.

Puregon 900 IU/1.08 mL solution for injection1.08 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminiumcrimp-cap with a rubber inlay.

Pack of 1 cartridge and 9 needles to be used with the Puregon Pen.

Cartridges contain a minimum of 1,025 IU FSH activity in 1.230 mL aqueous solution, which issufficient for a net total dose of 900 IU.

Do not use if the solution contains particles or if the solution is not clear.

Puregon solution for injection is designed for use in conjunction with the Puregon Pen. Theinstructions for using the pen must be followed carefully.

Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).

A small amount of Puregon solution for injection may remain in the cartridge after completion oftreatment with Puregon even when all doses have been correctly given. Patients should be instructednot to try to use the remaining Puregon solution for injection, but to properly discard the cartridge.

Empty cartridges must not be refilled.

Puregon cartridges are not designed to allow any other drug to be mixed in the cartridges.

Discard used needles immediately after injection.

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

N.V. Organon

Kloosterstraat 65349 AB Oss

The Netherlands

Puregon 150 IU/0.18 mL solution for injection

EU/1/96/008/040

Puregon 300 IU/0.36 mL solution for injection

EU/1/96/008/038

Puregon 600 IU/0.72 mL solution for injection

EU/1/96/008/039

Puregon 900 IU/1.08 mL solution for injection

EU/1/96/008/041

Date of first authorisation: 03 May 1996

Date of latest renewal: 29 May 2006

DD month YYYY

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

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