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Pregnyl 5000 IU (chorionic gonadotropin, hCG) – not marketed in Serbia: information and alternatives
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- Stock: Zabrana online prodaje
- Brand: ORGANON
- Model: BR-16654671
This medicine is currently not marketed in Serbia
- Pregnyl currently has no valid marketing authorisation in Serbia (ALIMS) and cannot be obtained in Serbian pharmacies, including ApotekaOnline.
- The authorisation (N.V. Organon, holder Merck Sharp & Dohme d.o.o., 515-01-05169-17-001 of 4 May 2018) was terminated by an ALIMS decision of 17 September 2019.
- Pregnyl is a medicine for infertility and hormonal disorders used only under the supervision of a specialist (gynaecologist, endocrinologist). It is not used for weight loss or for self-administration.
- This page is for information only and is not an offer to sell the medicine.
Pregnyl is a powder and solvent for solution for injection containing chorionic gonadotropin (hCG), 5000 international units (IU) per vial. hCG is obtained from the urine of pregnant women and has luteinising hormone (LH) activity, which triggers final follicle maturation and ovulation in women and testosterone production in men.
In countries where it is authorised, for example Ireland (marketing authorisation holder N.V. Organon), Pregnyl is indicated according to the official Summary of Product Characteristics for female infertility and certain hormonal disorders in men. The same indications were approved in Serbia until 2019.
What is Pregnyl, what is it used for and what is available in Serbia?
Key facts about the medicine
| Medicine name | Pregnyl®, 5000 IU, powder and solvent for solution for injection |
|---|---|
| Active substance | chorionic gonadotropin (hCG), from the urine of pregnant women |
| Strength | 5000 IU per vial (5000 IU/mL after reconstitution) |
| Pharmaceutical form | powder and solvent for solution for injection (intramuscular or subcutaneous) |
| Therapeutic group | gonadotropins (G03GA01) |
| Pack (formerly in Serbia) | vial with powder and vial with 1 mL solvent |
| Marketing authorisation holder | N.V. Organon, the Netherlands; formerly in Serbia: Merck Sharp & Dohme d.o.o. Belgrade |
| Status in Serbia | authorisation terminated 17 September 2019 – not marketed (formerly prescription-only) |
What is Pregnyl used for in countries where it is authorised?
According to the Summary of Product Characteristics (ALIMS 2018 and HPRA 2018):
- in women: ovulation induction in infertility due to anovulation or impaired follicle maturation; preparation of follicles for puncture in assisted reproduction; luteal phase support
- in men: hypogonadotropic hypogonadism; delayed puberty due to insufficient pituitary function; non-obstructive cryptorchidism (undescended testis) and preparation for surgery of an ectopic testis
How is it used?
After reconstitution the medicine is given intramuscularly or subcutaneously. The dose depends on the indication and response and is always decided by a specialist; for ovulation induction usually one injection of 5000 to 10000 IU is given to complete treatment with an FSH product, with ultrasound monitoring of follicles.
This describes the official leaflet and is not individual advice – dosing is decided by a doctor according to the official instructions.
Important safety information from the official documents
- Must not be used in hypersensitivity to hCG, known or suspected sex-hormone-dependent tumours (ovary, breast, uterus; prostate or breast in men), malformations of the reproductive organs or fibroids incompatible with pregnancy, or vaginal bleeding of unknown cause.
- Ovarian hyperstimulation syndrome (OHSS) can be severe and life-threatening – monitoring should last at least two weeks after administration.
- There is an increased risk of multiple pregnancy and, in assisted reproduction, of ectopic pregnancy and miscarriage.
- Thromboembolic complications and ovarian torsion are possible.
- hCG has no effect on fat metabolism or appetite and must not be used for weight loss.
- Pregnancy tests may be falsely positive for up to 10 days after administration.
- In men the medicine increases androgen production – caution with heart and kidney disease, hypertension, epilepsy and migraine; caution in prepubertal boys because of possible premature development.
- Pregnancy and breastfeeding: may be used for luteal phase support but not later in pregnancy; must not be used during breastfeeding.
- Side effects: injection-site reactions (bruising, pain, redness, swelling), less often rash and fever; in women OHSS symptoms; in men fluid retention and occasionally breast enlargement.
What is available in Serbia?
No urinary chorionic gonadotropin medicine named Pregnyl is currently authorised in Serbia. Ovitrelle® (choriogonadotropin alfa – recombinant hCG, Merck) is authorised as a solution for injection in a pre-filled pen of 250 micrograms/0.5 mL; its authorisation was renewed on 17 September 2024. Ovitrelle is intended for women undergoing assisted reproduction and for anovulatory or oligo-ovulatory women; it is not the same medicine as Pregnyl and is not a 1:1 replacement.
| Option | What it is | Note |
|---|---|---|
| Ovitrelle® 250 micrograms/0.5 mL pen | recombinant hCG (choriogonadotropin alfa), prescription-only | indications in women; dose and timing strictly according to the specialist’s protocol |
| Indications in men and boys | hypogonadism, delayed puberty, cryptorchidism | treatment is chosen by an endocrinologist, andrologist or paediatric surgeon |
| Food supplements when planning pregnancy | folic acid and multivitamins | not a substitute for infertility treatment; recommended for women planning pregnancy |
Any replacement is always decided by a specialist as part of the treatment plan for infertility or a hormonal disorder.
When to seek medical help immediately?
- severe pain or sudden swelling of the abdomen, nausea, vomiting, rapid weight gain after hCG
- difficulty breathing or markedly reduced urination
- pain, swelling or redness of a leg, chest pain or sudden shortness of breath
- swelling of the face or throat, hives or difficulty breathing after the injection
Pharmacist's advice
hCG treatment is part of a carefully planned infertility protocol – the timing of the injection, dose and ultrasound monitoring are set individually. The medicine must not be obtained or used on your own, and especially not for weight loss or in sport.
After an hCG injection, a home pregnancy test can be falsely positive for up to 10 days. It is therefore best to wait for the date set by your doctor or to have a blood test on their advice.
Availability and price
Pregnyl is currently not marketed in Serbia and cannot be bought in pharmacies, including ApotekaOnline. No price is available because the medicine has no valid authorisation.
This page is for information only. Infertility treatment is decided and monitored by a specialist.
Composition, packaging and manufacturer
- Active substance: chorionic gonadotropin (hCG) 5000 IU per vial; 5000 IU/mL after reconstitution.
- Solvent: clear, colourless aqueous solution for injection.
- Contains less than 1 mmol sodium per dose.
- Manufacturer and EU marketing authorisation holder: N.V. Organon, Kloosterstraat 6, Oss, the Netherlands.
Storage
- Store in a refrigerator at 2 °C to 8 °C, in the original package to protect from light.
- Shelf life unopened: 3 years; use the solution immediately after preparation.
- Keep out of the reach of children.
Frequently asked questions
Can Pregnyl be bought in Serbia?
No. The authorisation for Pregnyl in Serbia was terminated on 17 September 2019 and the medicine is not marketed.
What can replace Pregnyl?
For indications in women, Ovitrelle® (recombinant hCG) is authorised in Serbia. It is not the same medicine and is not switched automatically – the choice, dose and timing are decided by a specialist according to the treatment plan.
Does hCG help with weight loss?
No. According to the official Summary of Product Characteristics, hCG has no effect on fat metabolism, fat distribution or appetite and must not be used for weight reduction.
Can a pregnancy test be positive after an hCG injection?
Yes. The official documents state that a pregnancy test may be falsely positive for up to 10 days after hCG. For reliable confirmation, follow your doctor’s instructions.
Related information
For additional care and support with pregnancy planning, see also the Pregnancy and Ovulation Tests – Accuracy You Can Trust category – products in this category do not replace the medicine you have been prescribed.
Sources
- ALIMS – Summary of Product Characteristics, Pregnyl® 5000 IU (authorisation 515-01-05169-17-001 of 4 May 2018)
- ALIMS – List of medicines whose authorisation was terminated, 21 July – 30 September 2019 (Pregnyl®)
- HPRA (Ireland) – Summary of Product Characteristics, Pregnyl 5000 IU (N.V. Organon, revised April 2018)
- ALIMS – Summary of Product Characteristics, Ovitrelle® 250 micrograms (revised September 2024)
- ALIMS – List of new authorisations and renewals until 31 Dec 2024 (Ovitrelle®, renewed 17 Sep 2024)
Sources checked on: 23 October 2026.
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Additional information
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Shipping cost
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For goods ordered up to 5.000,00 RSD, delivery charge is 260.00 RSD (VAT included). For goods over 5.000,00 RSD, shipping is free of charge.
For international delivery:
For the export of goods abroad through the PostExport service of Post of Serbia, the shipping price is for:
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