ກົມອາຫານ ແລະ ຢາ :: ກະຊວງສາທາລະນະສຸກ, ສປປລາວ ::

Items	Registration information
ID	681
No	681
Brand Name	UTROGESTAN 200 MG
Ingredients	PROGESTERONE MICRONIZED PH EUR 200 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 15'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	OVOID, SLIGHTLY YELLOW CAPSULE CONTAING A WHITISH OILY SUSPENSION
Note
License Owner	EXAMED CO.,LTD
Manufacturer	CYNDEA PHARMA, S.L.
Country	BELGIUM
Import Registration No	BE279386
Import Registration Date	1981-09-01
Activity	CERTIFICATE RELEASED
Applied Date	2024-10-01
FDD Registration No	01 I 5170/22
FDD Registration Date	2024-10-25
Expiry Date	2029-10-24