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Ibuprofen Pinewood 400 mg Film-coated Tablets



Pinewood Laboratories LtdPA0281/088/002

Main Information

Trade NameIbuprofen Pinewood 400 mg Film-coated Tablets
Active SubstancesIbuprofen
Dosage FormFilm-coated tablet
Licence HolderPinewood Laboratories Ltd
Licence NumberPA0281/088/002

Group Information

ATC CodeM01AE Propionic acid derivatives
M01AE01 ibuprofen

Status

License statusWithdrawn
Withdrawn Date20/12/2023
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThe following must be submitted to the IMB prior to releasing Film-coated tablets manufactured at the IPCA laboratories Limited manufacturing site onto the Irish market: 1. Batch numbers used in the process validation studies for film-coated tablets manufactured at the IPCA site. 2. Batch analysis data, on one production batch and two pilot-side batches (or two production batches) manufactured at the IPCA site along with comparative data for film-coated product manufactured at the Watson Pharma Private Limited manufacturing site. 3. Proof that the IPCA site is authorised to manufacture film-coated tablets.
Marketing StatusNot marketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
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