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Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.
Drugsrus Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Clexane 10,000IU (100mg)/1 ml Syringes contains a typographical error in the leaflet.
Intrapharm Laboratories Ltd has informed us that they have received complaints that the consistency of a batch of Kolanticon Gel 500ml is lumpy. An investigation and retained samples for this batch show the same homogeneity issue.
Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse reaction reports have been received by...
Rosemont Pharmaceuticals Ltd. has made the MHRA aware that the expiry dates stamped on the base of the bottle are incorrect for 2 batches of Atorvastatin 4mg/ml Oral Suspension and 2 batches of Sildenafil 10mg/ml Oral Suspension.
Cases of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido, have been reported rarely in patients taking oral isotretinoin for severe acne.
EAMS scientific opinion given to Roche Products Limited for atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy
Decisions made by MHRA following investigations into complaints about advertising for licensed medicines.
Use only when other antibiotics are unsuitable
Seeks views on proposed changes to the NHS availability of Sildenafil for men with erectile dysfunction.
First published during the 2010 to 2015 Conservative and Liberal Democrat coalition government
A European review has begun into the safety of radium-223 dichloride following an observed increase in the incidence of deaths and fractures in patients with chemotherapy-naive metastatic castration-resistant prostate cancer receiving radium-223 dichloride in combination with abiraterone acetate (Zytiga) and...
The CMA has accepted legally binding commitments from Essential Pharma to continue supplying a key bipolar drug at an affordable price for at least 5 years.
The Competition Appeal Tribunal has upheld the CMA decision that GlaxoSmithKline and some generic suppliers of the anti-depressant paroxetine broke competition law.
Claris Lifesciences UK Ltd are asking pharmacists and wholesalers to check packs of Furosemide-Claris 20mg/2ml Injection (Marketing Authorisation number AUST R 148003) as they have been inadvertently distributed in the UK and are intended for the Australian market.
Now only authorised for use in patients with symptomatic bone metastases and no known visceral metastases who have had 2 previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive other systemic treatments. Do not use in combination...
Cipla (EU) Limited has informed MHRA that there is an error on the Patient Information Leaflet (PIL) for the above product: the dosage information for the indication CML is incorrect
The CMA is investigating alleged anti-competitive agreements in the pharmaceutical sector under Chapter I CA98 (case reference: 50511-1).
Updated prescribing advice provided.
A review has found that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-containing contrast agents (GdCAs). There is currently no evidence that gadolinium deposition in the brain has caused adverse neurological...
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