VALCYTE 50 MG
VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) : 50 MG · DIN 02306085 · CHEPLAPHARM ARZNEIMITTEL GMBH
Health Canada status: MARKETED
What is VALCYTE?
VALCYTE 50 MG contains VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02306085, held by CHEPLAPHARM ARZNEIMITTEL GMBH, supplied as POWDER FOR SOLUTION for ORAL administration. Health Canada currently lists it as marketed, status dated 19-Jul-2022. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is VALCYTE used for?
Treatment of CMV retinitis in patients with AIDS; Prevention of CMV disease in solid organ transplant patients at risk (donor+/recipient-).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02306085 |
|---|---|
| Brand name | VALCYTE |
| Generic / active ingredient | VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) : 50 MG |
| Manufacturer | CHEPLAPHARM ARZNEIMITTEL GMBH |
| Strength | 50 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | J05AB14 VALGANCICLOVIR |
| AHFS class | 84:80.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 19-Jul-2022 |
| Original market date | 2008-04-02 00:00:00 |
How is it administered?
Induction (CMV retinitis): 900 mg BID for 21 days. Maintenance/Prevention: 900 mg once daily. Take with food. Dosage adjustment required for renal impairment.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Reconstituted solution: 49 days at 2-8°C. (Tablet/Powder storage temperature not explicitly stated in provided text snippet).
How is it supplied?
Tablets: Plastic bottles of 60. Powder for Oral Solution: 12 g powder in amber glass bottle (100 mL reconstituted) with 2 oral dispensers.
Contraindications
Hypersensitivity to valganciclovir, ganciclovir, acyclovir, valacyclovir, or any ingredient in the formulation.
Warnings and precautions
Serious hematologic toxicity (neutropenia, anemia, etc.); potential teratogen/carcinogen; strict adherence to dosage to avoid overdose; not for non-immunocompromised.
What can be used instead?
Other Canadian products sharing ATC code J05AB14 VALGANCICLOVIR. 6 of 9 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| AURO-VALGANCICLOVIR | 450 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02435179 |
| AURO-VALGANCICLOVIR | 50 MG | POWDER FOR SOLUTION | AURO PHARMA INC | MARKETED | DIN 02535483 |
| MINT-VALGANCICLOVIR | 450 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | DIN 02495457 |
| TEVA-VALGANCICLOVIR | 450 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02413825 |
| VALCYTE | 450 MG | TABLET | CHEPLAPHARM ARZNEIMITTEL GMBH | MARKETED | DIN 02245777 |
| APO-VALGANCICLOVIR | 450 MG | TABLET | APOTEX INC | DORMANT | DIN 02393824 |
| MYLAN-VALGANCICLOVIR | 450 MG | TABLET | MYLAN PHARMACEUTICALS ULC | CANCELLED PRE MARKET | DIN 02426579 |
| NAT-VALGANCICLOVIR | 450 MG | TABLET | NATCO PHARMA (CANADA) INC | CANCELLED PRE MARKET | DIN 02465744 |
Who else supplies VALGANCICLOVIR worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. VALGANCICLOVIR appears in 65 registered pack listings across 13 markets, published on 11 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.