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Utrogestan 100 mg Oral Capsule

NAFDAC Reg. No. C4-1610 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Utrogestan 100 mg Oral Capsule
NAFDAC number
C4-1610
Active ingredient
Progesterone
Strength
100 mg
Form
Capsule
Pack size
2 x 15's
Manufacturer
Not listed
Applicant (holder)
Assene-Laborex Limited
Approved
25 Feb 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
24 Feb 2026
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Utrogestan 100 mg Oral Capsule is on the NAFDAC register with an active registration (C4-1610). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Utrogestan 100 mg Oral Capsule is used for

From the official U.S. FDA label for progesterone, the active ingredient registered with NAFDAC.

Boxed warning: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS , Cardiovascular disorders and Probable dementia . …
What it is used for

Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.

Possible side effects

See BOXED WARNING , WARNINGS and PRECAUTIONS. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of progesterone capsules on the endometrium was studied in a total of 875 postmenopausal women. …

Do not use if

Progesterone capsules should not be used in women with any of the following conditions: Progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer. Active deep vein thrombosis, pulmonary embolism or history of these conditions. …

Warnings

See BOXED WARNING . 1. Cardiovascular disorders An increased risk of pulmonary embolism, deep vein thrombosis (DVT), stroke, and myocardial infarction has been reported with estrogen plus progestin therapy. Should any of these occur or be suspected, estrogen with progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history or family history of venous thromboembolism [VTE], obesity, and systemic lupus erythematosus) should be managed appropriately. a. …

Pregnancy & breastfeeding

E. Pregnancy Progesterone capsules should not be used during pregnancy. (See CONTRAINDICATIONS .) Pregnancy Category B: Reproductive studies have been performed in mice at doses up to 9 times the human oral dose, in rats at doses up to 44 times the human oral dose, in rabbits at a dose of 10 mcg/day delivered locally within the uterus by an implanted device, in guinea pigs at doses of approximately one-half the human oral dose and in rhesus monke …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Utrogestan 100 mg Oral Capsule

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Utrogestan 100 mg Oral Capsule

What is in Utrogestan 100 mg Oral Capsule?

Utrogestan 100 mg Oral Capsule contains Progesterone (100 mg), as capsule, according to its NAFDAC registration record.

Is Utrogestan 100 mg Oral Capsule registered with NAFDAC?

Yes. Utrogestan 100 mg Oral Capsule is listed on the NAFDAC register under registration number C4-1610, and its registration is active as of 27 October 2026.

Has Utrogestan 100 mg Oral Capsule been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Utrogestan 100 mg Oral Capsule in our automatically synced alert list.

How can I check that my pack of Utrogestan 100 mg Oral Capsule is genuine?

Run a free authenticity scan with the NAFDAC number C4-1610, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Utrogestan 100 mg Oral Capsule used for?

Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea. (Summarised from the official U.S. FDA label for progesterone. Always follow your doctor or pharmacist.)

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