Transcription of Public Assessment Report Mutual Recognition …
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Public Assessment Report Mutual Recognition …
PAR Sayana 104 suspension for Injection UK/H/0960/001/MR 1 Public Assessment Report Mutual Recognition Procedure SAYANA 104 suspension FOR INJECTION UK/H/0960/001/MR UK licence no: PL 00057/0589 Pfizer Limited PAR Sayana 104 suspension for Injection UK/H/0960/001/MR 2 SAYANA 104 suspension FOR INJECTION LAY SUMMARY On 9th July 2007, Austria, Belgium, Czech Republic, Germany, Hungary, Ireland, The Netherlands, Norway and Poland granted Marketing Authorisations to Pfizer Limited for the medicinal product Sayana 104 suspension for Injection. The licences were granted by Mutual Recognition Procedure (MRP), with the UK as Reference Member State (RMS). A licence had previously been granted in the UK on 26th October 2005. Sayana 104 suspension for Injection can be used: For long-term contraception, as decided by the patient and the healthcare provider. However, use for longer than 2 years is only after re-evaluation of the risks versus benefits by the healthcare provider to make sure that it is still the best option.
PAR Sayana 104mg/0.65ml Suspension for Injection UK/H/0960/001/MR 1 Public Assessment Report Mutual Recognition Procedure SAYANA 104MG/0.65ML SUSPENSION FOR INJECTION
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