Pharming Receives Agreement On Paediatric Investigation Plan For Rhucin(R) From The EMEA Paediatric Committee

Main Category: Arthritis / Rheumatology
Also Included In: Pediatrics / Children's Health
Article Date: 10 Jun 2009 - 1:00 PST

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Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that the Paediatric Committee (PDCO) of the European Medicines Agency (EMEA) has adopted an opinion agreeing the paediatric investigation plan (PIP) for Rhucin® (recombinant human C1 inhibitor) in the therapeutic area of immunology-rheumatology transplantation.

"Agreement of the PIP represents a key milestone in Pharming's regulatory plans for the September 2009 submission of the Rhucin marketing authorisation application," said Dr. Bruno Giannetti, COO of Pharming.

According to the EC Regulation 1901/2006 of 12 December 2006, pharmaceutical companies that submit an application for a marketing authorisation for a medicinal product (MAA) in the EU, have to include an approved PIP as part of the regulatory submission.

Source
Pharming Group NV