NOVAXIL PLUS

Organization name

Rompharm Company SRL

SRN

RO-MF-000002517

Manufacturer status

Active

9 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW999

  CONTRAINDICATIONS: is contraindicated in patients with: • known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate or to any components of NOVAXIL PLUS • pre-existing infections or skin diseases in the area of the intended injection site • known infection of the index joint • known systemic bleeding disorders, bleeding or tendency to bleeding NOVAXIL PLUS may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. NOVAXIL PLUS should not be used in patients with known hypersensitivity to derived bovine material.
• CW999

  Injection site must be properly disinfected (70% alcohol or with another disinfectant). Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronic acid can precipitate in their presence.
• CW999

  NOVAXIL PLUS should be administered in the synovial joint space only by medical professionals trained in intra-articular administration technique.
• CW999

  As no clinical evidence is available on the use of sodium hyaluronate and chondroitin sodium sulfate in patients with concomitant inflammatory arthropathy (such as rheumatoid arthritis, gouty arthritis), recent orthopedic surgery or trauma at the index joint, the treatment with NOVAXIL PLUS is not recommended in these patients.

Primary placement in Poland; available across 1 country total.

Trade name

not provided

UDI-DI code

05944728007475

Basic UDI-DI

B-05944728007475

Reference / catalog number

NOVAXIL PLUS

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

NOVAXIL PLUS is a sterile, viscoelastic solution containing two highly purified cross-linked biological polymers, sodium hyaluronate and chondroitin sodium sulfate. NOVAXIL PLUS consists of sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain and chondroitin sodium sulfate produced from bovine cartilage. NOVAXIL PLUS is a sterile viscoelastic solution processed using an aseptic processing technique and supplied in a disposable glass syringe delivering 3 mL of solution.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 3 MU03

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES