MYLAN-NEVIRAPINE 200 MG
NEVIRAPINE : 200 MG · DIN 02387727 · MYLAN PHARMACEUTICALS ULC
Health Canada status: MARKETED
What is MYLAN-NEVIRAPINE?
MYLAN-NEVIRAPINE 200 MG contains NEVIRAPINE : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02387727, held by MYLAN PHARMACEUTICALS ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 20-Jun-2012. 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 MYLAN-NEVIRAPINE used for?
Treatment of HIV-1 infection in combination with other antiretroviral agents. Not for monotherapy. Use caution in patients with higher CD4 counts due to toxicity risks.
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 | 02387727 |
|---|---|
| Brand name | MYLAN-NEVIRAPINE |
| Generic / active ingredient | NEVIRAPINE : 200 MG |
| Manufacturer | MYLAN PHARMACEUTICALS ULC |
| Strength | 200 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | J05AG01 NEVIRAPINE |
| AHFS class | 08:18.08.16 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 20-Jun-2012 |
| Original market date | 2012-06-20 00:00:00 |
How is it administered?
Initiate with 200 mg once daily for 14 days (lead-in period), followed by 200 mg twice daily in combination with other antiretrovirals. Strict adherence to lead-in is required to reduce rash risk.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in the provided text summary (refer to full section 42 for details).
How is it supplied?
Not explicitly detailed in the provided text summary (refer to full section 42 for details).
Contraindications
Hypersensitivity; severe hepatic dysfunction; pre-treatment AST/ALT >5X ULN; previous permanent discontinuation due to nevirapine-induced rash or hepatitis; St. John’s wort use.
Warnings and precautions
Fatal hepatotoxicity and severe skin reactions (SJS/TEN) risk. Do not start in women with CD4 >250 or men with CD4 >400 unless benefits outweigh risks. Intensive monitoring for first 18 weeks.
What can be used instead?
Other Canadian products sharing ATC code J05AG01 NEVIRAPINE. 3 of 8 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-NEVIRAPINE | 200 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02318601 |
| JAMP NEVIRAPINE | 200 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02405776 |
| APO-NEVIRAPINE | 200 MG | TABLET | APOTEX INC | APPROVED | DIN 02396653 |
| APO-NEVIRAPINE XR | 400 MG | TABLET (EXTENDED-RELEASE) | APOTEX INC | CANCELLED POST MARKET | DIN 02427931 |
| TEVA-NEVIRAPINE | 200 MG | TABLET | TEVA CANADA LIMITED | CANCELLED POST MARKET | DIN 02352893 |
| VIRAMUNE | 200 MG | TABLET | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | CANCELLED POST MARKET | DIN 02238748 |
| VIRAMUNE XR | 400 MG | TABLET (EXTENDED-RELEASE) | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | CANCELLED POST MARKET | DIN 02367289 |
Who else supplies NEVIRAPINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. NEVIRAPINE appears in 700 registered pack listings across 8 markets, published on 7 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.