| ID | 599 |
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| No | 599 |
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| Brand Name | ROTARIX |
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| Ingredients | LIVE ATTENUATED HUMAN ROTAVIRUS RIX4414 STRAIN NOT LESS THAN 10 6.0 CCID 50 |
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| Dosage Form | ORAL SUSPENSION |
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| Primary Packaging | TUBE |
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| Storage | +2'C TO +8'C |
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| Shelf Life | 36 MONTHS |
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| Pack Size | BOX OF 1 TUBE ( 1 DOSE (1.5 ML)) |
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| Dispensing Category | Prescription only |
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| ATC Classification | XX |
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| Pharmaceutical Class | VACCINES, ANTISERA & IMMUNOLOGICALS |
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| Indications | FOR THE ACTIVE IMMUNISATION OF INFANTS AGED 6-24 WEEKS FOR PREVENTION OF GASTRO-ENTERITIS DUE TO ROTAVIRUS INFECTION |
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| Contraindications | ROTARIC SHOULD NOT BE ADMISTERED TO SUBJECTS WITH KNOW HYPERSENSITIVITY AFTER PREVIOUS ADMINISTRATION OF ROTARIX VACCIN. |
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| Side Effects | THE SAFETY PROFILE PRESENTED BELOW IS BASED ON DATA FROM CLINICAL TRIALS CONDUCTED WITH EITHER THE LYOPHILISED OR THE LIQUID FOR MULATION OF ROTARIX. |
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| Unit Price | - |
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| EDL |
No |
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| Description | CLEAR AND COLOURLESS LIQUID |
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| Note | |
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| License Owner | DKSH LAOS COMPANY LIMITED |
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| Manufacturer | GLAXOSMITHKLINE BIOLOGICALS S. A |
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| Country | BELGIUM |
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| Import Registration No | EU/1/05/330/005-011 |
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| Import Registration Date | 1.9.2008 |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | 2024-02-23 |
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| FDD Registration No | 02 I 3839/13 |
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| FDD Registration Date | 2024-04-08 |
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| Expiry Date | 2027-04-07 |
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