Raylumis

Unknown🇪🇺 European Union

EMA Page

Authorised Date: N/A
Approval ID: 0df70004fe10f7fd
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

The European Medicines Agency has recommended the refusal of the marketing authorisation for Raylumis, a medicine intended for the treatment of pain associated with osteoarthritis. The Agency issued its opinion on 16 September 2021\. The company that applied for authorisation, Pfizer Europe MA EEIG, may ask for re\-examination of the opinion within 15 days of receiving the opinion.

Therapeutic & Classification

Therapeutic Indication

N/A

Therapeutic Area (MeSH)

Osteoarthritis

Pain

ATC Code

N02

ATC Item

N/A

Pharmacotherapeutic Group

Analgesics

Active Substances

Active Substance (Summary)

tanezumab

INN / Common Names

tanezumab

Active Substance Details

Active substance details are not yet available.

Quick Info

Approval ID0df70004fe10f7fd

Product NumberN/A

StatusAuthorised

Authorised DateN/A

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Raylumis

Medicine Name

Raylumis

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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