View drug registration information details.
| Items | Registration information |
|---|
| ID | 678 |
|---|
| No | 678 |
|---|
| Brand Name | UTROGESTAN 100 MG |
|---|
| Ingredients | PROGESTERONE MICRONIZED PH EUR 100 MG |
|---|
| Dosage Form | SOFT CAPSULE, ORAL ROUTE |
|---|
| Primary Packaging | ALU-PVC BLISTER PACK |
|---|
| Storage | NO SPECIAL CONDITION |
|---|
| Shelf Life | 36 MONTHS |
|---|
| Pack Size | BOX OF 30'S |
|---|
| Dispensing Category | Prescription only |
|---|
| ATC Classification | G03DA04 |
|---|
| Pharmaceutical Class | SEX HORMONE |
|---|
| Indications | DISORDERS ASSOCIATED WITH A PROGESTERONE DEFICIT IN PARTICULAR: PRE-MENSTRUAL SYNDROME, MENSTRUAL IRREGULARITIES DUE TO OVULATION DISORDERS OR ANOVULATION, BENIGN MASTOPATHY, PREMENOPAUSE, INFERTILITY CAUSED BY LUTEAL PHASE DEFECT, MENACE OF PRETERM DELIVERY |
|---|
| Contraindications | KNOWN HYPERSENSITIVITY TO THE ACTIVE SUBSTANCE OR ANY OF THE EXCIPIENT, SEVERE CHANGES IN HEPATIC FUNCTION |
|---|
| Side Effects | ALTERED MENSTRUAL CYCLES, AMENORRHOEA, INTERMENSTRUAL BLEEDING, HEADACHE, DROWNSINESS, TRANSIENT DIZZINESS, CHOLESTATIC JAUDICE, PRURITUS, GASTROINTESTINAL DISORDERS. |
|---|
| Unit Price | |
|---|
| EDL |
No |
|---|
| Description | ROUND, SLIGHTLY YELLOW CAPSULE CONTAING A WHITISH OILY SUSPENSION |
|---|
| Note | |
|---|
| License Owner | EXAMED CO.,LTD |
|---|
| Manufacturer | CYNDEA PHARMA, S.L. |
|---|
| Country | BELGIUM |
|---|
| Import Registration No | BE117923 |
|---|
| Import Registration Date | 1981-09-01 |
|---|
| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 2024-10-01 |
|---|
| FDD Registration No | 01 I 5168/22 |
|---|
| FDD Registration Date | 2024-10-25 |
|---|
| Expiry Date | 2029-10-24 |
|---|
Back to drug list
|
