Progesterone

Arefam, Cyclogest, Novitera, Progedex · ATC code G03DA04

Also known as: Progesteron, Prometrium · Brand names: Arefam, Cyclogest, Novitera, Progedex, Utrogestan, Crinone, Cyclogest®, Estima, Famenita, Lutinus, Progestan, Progestogel, Prolutex, Utrogest Luteal, Gestinax …

Key facts
Active substance: Progesterone
ATC code: G03DA04
Authorisation: authorised nationally; no central EU authorisation
Information as of: 2026-10-27

Key facts

Progesterone is a natural progestogen. Per the US label, the capsules are used to prevent endometrial hyperplasia in postmenopausal women on estrogen and to treat secondary amenorrhea.

What it is used for

Prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving conjugated estrogens
Secondary amenorrhea

Dosing

Endometrial hyperplasia prevention: 200 mg once daily at bedtime for 12 days sequentially per 28-day cycle, with daily conjugated estrogens
Secondary amenorrhea: 400 mg once daily at bedtime for 10 days
Women with difficulty swallowing should take the capsules with a glass of water while standing
May cause drowsiness; taken at bedtime

Contraindications

Hypersensitivity to ingredients; capsules contain peanut oil (contraindicated in peanut allergy)
Abnormal genital bleeding of unknown etiology
Known, suspected or history of breast cancer
Active or history of deep vein thrombosis, pulmonary embolism or arterial thromboembolic disease (e.g. stroke, myocardial infarction)
Known liver dysfunction or disease

Important warnings

Discontinue immediately if PE, DVT, stroke or MI occurs; if feasible stop 4 to 6 weeks before surgery with increased thromboembolism risk
The WHI trial reported increased risks of PE, DVT, stroke and MI with estrogen plus progestin
More abnormal mammograms with estrogen plus progestin; discontinue if a hormone-sensitive malignancy is diagnosed
Drowsiness and dizziness: caution when driving or operating machinery

Side effects

In a trial (with conjugated estrogens), common: headache (31%), breast tenderness (27%), joint pain (20%), depression (19%), dizziness (15%)
Others: abdominal bloating, hot flashes, urinary problems, vaginal discharge, nausea/vomiting

Pregnancy and breastfeeding

Should not be used during pregnancy
Progestins have been detected in breast milk; use caution in nursing women

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

ArefamExeltis Germany Gmbh · 1 register entry
CyclogestGedeon Richter Plc. · 1 register entry
NoviteraExeltis Germany Gmbh · 1 register entry
ProgedexIbsa Farmaceutici Italia · 3 register entries
UtrogestanBesins Healthcare S.A., Besins Healthcare Germany Gmbh · 3 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

CrinoneMerck Healthcare Germany Gmbh · 1 register entry
CyclogestGedeon Richter Plc. · 1 register entry
Cyclogest®Gedeon Richter Plc. · 1 register entry
EstimaEffik · 1 register entry
FamenitaExeltis Germany Gmbh · 1 register entry
LutinusFerring Gmbh · 1 register entry
ProgestanBesins Healthcare Germany Gmbh · 1 register entry
ProgestogelBesins Healthcare Germany Gmbh · 1 register entry
ProlutexIbsa Farmaceutici Italia · 2 register entries
Utrogest LutealBesins Healthcare Germany Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

CrinoneMERCK İLAÇ ECZA VE KİMYA TİC. A.Ş., SERONO İLAÇ PAZ. VE TİC. A.Ş. · 2 register entries
CyclogestASSOS İLAÇ KİMYA GIDA ÜRÜNLERİ ÜRETİM VE TİC. A.Ş. · 2 register entries
GestinaxDEVA HOLDİNG A.Ş. · 2 register entries
PregetoxDEVA HOLDİNG A.Ş. · 2 register entries
ProgestanKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 8 register entries
ProgynexFARMAKO ECZACILIK A.Ş., KOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 6 register entries
ProlutexIBSA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
PromesterVEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

CrinoneAllergan, Inc. · 1 register entry
EndometrinFerring Pharmaceuticals Inc. · 1 register entry
PrometriumAcertis Pharmaceuticals, LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 27 more European countries

Belgium: Amelgen, Gepretix, Inprosub, Progebel, Progestogel, Utrogestan
Bulgaria: Prolutex, Кринон, Лутинус, Прогестогел, Пролутекс, Утрогестан, Циклогест
Croatia: Crinone, Cyclogest, Utrogestan
Cyprus: Cyclogest, Prolutex, Utrogestan, Vasclor
Czechia: Agolutin, Amelgen, Gynprodyl, Progesteron Besins, Prolutex, Utrogestan
Denmark: Crinone, Cyclogest, Lutinus, Prolutex
Estonia: Amelgen, Crinone, Gepretix, Lubion, Utrogestan
Finland: Crinone, Cyclogest, Gepretix, Lugesteron, Lutinus, Prolutex
France: Amelgen, Crinone, Estima, Phasella, Progestan, Progesterone Biogaran, Progesterone Viatris, Progestogel, Progiron, Utrogestan
Greece: Crinone, Cyclogest, Lutinus, Mastopon-Treat, Prolutex, Promenorea, Vasclor
Hungary: Crinone, Cyclogest, Lutinus, Progesterone Exeltis, Prolutex, Utrogestan
Iceland: Crinone, Cyclogest, Lutinus, Progestan, Progesterone Alvogen
Ireland: Crinone, Lubion, Lutinus, Progesterone
Italy: Amelgen, Crinone, Esolut, Pleyris, Prometrium, Prontogest, Utrogestan
Latvia: Amelgen, Crinone, Gepretix, Lubion, Lutavia
Lithuania: Crinone, Gepretix, Lubion, Lutavia, Progesterone Besins
Luxembourg: Amelgen, Inprosub, Progebel, Progestogel, Utrogestan
Malta: Cyclogest, Seidigestan, Utrogestan
Netherlands: Crinone, Cyclogest, Lutinus, Prolutex, Utrogestan
Norway: Crinone, Cyclogest, Gepretix, Lutinus, Prolutex
Poland: Crinone, Cyclogest, Famenita, Lustork, Luteina, Lutezin, Lutinus, Progesteron Adamed, Prolutex, Utrogestan
Portugal: Cyclogest, Folac, Gepretix, Gosegyne, Prolutex, Utrogestan
Romania: Arefam, Crinone, Cyclovita, Lutinus, Mastoprofen, Prolutex, Utrogestan
Slovakia: Agolutin, Amelgen, Progestanelle, Prolutex, Utrogestan
Slovenia: Amelgen, Crinone, Utrogestan
Spain: Cyclogest, Darstin, Fergesten, Gepretix, Progeffik, Prolutex, Seidigestan, Utrogestan
Sweden: Crinone, Cyclogest, Gepretix, Lutinus, Prolutex, Utrogestan

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

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Sources

U.S. Food and Drug Administration. Prometrium (Acertis Pharmaceuticals, LLC) – Prescribing Information, 2026-07-23. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1cf237ff-c4f8-4faa-a7aa-77599c856889
EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.