View drug registration information details.
| Items | Registration information |
|---|
| ID | 421 |
|---|
| No | 421 |
|---|
| Brand Name | UTROGESTAN 100 MG |
|---|
| Ingredients | PROGESTERONE MICRONIZED PH EUR 100 MG |
|---|
| Dosage Form | SOFT CAPSULE, VAGINAL ROUTE |
|---|
| Primary Packaging | ALU-PVC BLISTER PACK |
|---|
| Storage | STORE BELOW 30C |
|---|
| Shelf Life | 36 MONTHS |
|---|
| Pack Size | BOX OF 30'S |
|---|
| Dispensing Category | Prescription only |
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| ATC Classification | G03DA04 |
|---|
| Pharmaceutical Class | SEX HORMONE |
|---|
| Indications | SUPPORT DURING OVARIAN INSUFFICIENCY OR COMPLETE OVARIAN FAILURE IN WOMEN LACKING OVARIAN FUNCTION, LUTEAL PHASE SUPPORT DURING IN-VITRO FERTILIZATION CYCLE, MENACE OF ABORTION OR PREVENTION OF RECURRENT SPONTANEOUS ABORTIONS DUE TO LUTEAL PHASE DEFECT UP TO 12TH WEEK OF PREGNANCY, MENACE OF PRETERM DELIVERY |
|---|
| Contraindications | KNOWN HYPERSENSITIVITY TO THE ACTIVE SUBSTANCE OR ANY OF THE EXCIPIENT, SEVERE CHANGES IN HEPATIC FUNCTION |
|---|
| Side Effects | LOCAL IRRITATION, |
|---|
| Unit Price | |
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| EDL |
No |
|---|
| Description | ROUND, SLIGHTLY YELLOW CAPSULE CONTAING A WHITISH OILY SUSPENSION |
|---|
| Note | |
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| License Owner | EXAMED CO.,LTD |
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| Manufacturer | CYNDEA PHARMA, S.L. |
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| Country | BELGIUM |
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| Import Registration No | BE178954 |
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| Import Registration Date | 2006-10-22 |
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| Activity | CERTIFICATE RELEASED |
|---|
| Applied Date | 2024-10-01 |
|---|
| FDD Registration No | 01 I 5167/22 |
|---|
| FDD Registration Date | 2024-10-25 |
|---|
| Expiry Date | 2029-10-24 |
|---|
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