Safety Circulars

Archived Safety Circulars

2019-2023

         

2018-2014 

         

2013-2009

         

2008-2004

   

2018

 

2013

 

2008

   

2017

 

2012

 

2007

2021 

 

2016

 

2011

 

2006

2020

 

2015

 

2010

 

2005

2019

 

2014 

 

2009

 

2004

Disclaimer: Despite efforts made to deliver this information, we cannot exclude inadvertent errors or omissions in this page. While every effort is made to ensure the accuracy of the information, it is not possible to guarantee that it is complete, accurate and up-to-date.


Safety circular reference numbers are unique but not necessarily sequential.

2021

Medicines Authority Circular No P12/2021 RE: COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect - 28.07.2021

Medicines Authority Circular No P11/2021 RE: EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome - 13.07.2021

Medicines Authority Circular No P10/2021 RE: Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis - 12.07.2021

Medicines Authority Circular No P09/2021 RE: EMA starts review of anxiety medicine Stresam (etifoxine) - 25.06.2021

Medicines Authority Circular No P08/2021 RE: EMA advises against use of Vaxzevria in people with history of capillary leak syndrome - 18.05.2021

Medicines Authority Circular No P06/2021 RE: Vaxzevria: further advice on blood clots and low blood platelets  - 24.05.2021

Medicines Authority Circular No P05/2021 RE: Benefits of ifosfamide solutions continue to outweigh risks  - 13.05.2021

Medicines Authority Circular No P04/2021 RE: COVID-19 Vaccine AstraZeneca - Review of very rare cases of unusual blood clots concluded - Possible link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia  - 08.04.2021

Medicines Authority Circular No P02/2021 RE: COVID-19 Vaccine AstraZeneca - Update following extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) to review thromboembolic events - Benefits still outweigh the risks  - 23.03.2021

Medicines Authority Circular No P01/2021 RE: COVID-19 Vaccine AstraZeneca - European Medicines Agency’s Pharmacovigilance Risk Assessment Committee preliminary view suggests no specific issue with batch used in Austria - 11.03.2021

 

2020

Medicines Authority Circular No P29/2020 RE: Nitrosamines: recommendations for sartans aligned with those for other medicines by EMA - 19.01.2021

Medicines Authority Circular No P28/2020 RE: EMA recommends restricting use of Ulipristal acetate for uterine fibroids  - 19.01.2021

Medicines Authority Circular No P26/2020 RE: COVID-19: EMA endorses the use of dexamethasone in patients on oxygen or mechanical ventilation - 02.10.2020

Medicines Authority Circular No P24/2020 RE: Yondelis: unchanged use for the cancer medicine following review of new data - 19.08.2020

Medicines Authority Circular No P23/2020 RE: Dexamethasone for treating adults with COVID 19 requiring respiratory support: EMA starts a review - 19.08.2020

Medicines Authority Circular No P20/2020 RE: Leuprorelin depot medicines: new measures to avoid handling errors - 22.07.2020

Medicines Authority Circular No P19/2020 RE: ACE Inhibitors and ARM Medicines: Continued use during COVID-19 pandemic - 18.06.2020

Medicines Authority Circular No P17/2020 RE: Fluorouracil, capecitabine, tegafur and flucytosine: EMA recommends DPD testing prior to treatment - 20.05.2020

Medicines Authority Circular No P15/2020 RE: CHMP proposes to suspend Ranitidine medicines in the EU - 20.05.2020

Medicines Authority Circular No P14/2020 RE: Reminder of potential risk of serious side effects associated with the use of chloroquine and hydroxychloroquine in the context of COVID-19 pandemic - 23.04.2020

Medicines Authority Circular No P13/2020 RE: EMA advices on use of medicines for hypertension, heart or kidney diseases during COVID-19 pandemic - 17.04.2020

Medicines Authority Circular No P11/2020 RE: Use of fosfomycin antibiotics restricted following EMA review - 17.04.2020

Medicines Authority Circular No P10/2020 RE: Direct oral anticoagulants: no change in use - 17.04.2020

Medicines Authority Circular No P09/2020 RE: Cyproterone medicines: use restricted due to meningioma risk - 17.04.2020

Medicines Authority Circular No P07/2020 RE: Ulipristal acetate for uterine fibroids suspended during ongoing EMA review of liver injury risk - 14.04.2020

Medicines Authority Circular No P06/2020 RE: Ifosfamide cancer medicines: EMA starts a review - 14.04.2020

Medicines Authority Circular No P05/2020 RE: Yondelis: review started - 20.03.2020

 

2019

Medicines Authority Circular No P25/2019 RE: Metformin diabetes medicines: an update from EMA - 06.12.2019

Medicines Authority Circular No P24/2019 RE: Xeljanz: the EMA confirms to use the medicine cautiously in patients at high risk of blood clots - 05.12.2019

Medicines Authority Circular No P23/2019 RE: Lemtrada for multiple sclerosis: measures to minimise risk of serious side effects - 05.12.2019

Medicines Authority Circular No P18/2019 RE: New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases - 26.09.2019

Medicines Authority Circular No P20/2019 RE: EMA starts a review on ranitidine-containing products following detection of NDMA - 20.09.2019

Medicines Authority Circular No P17/2019 RE: Multiple sclerosis medicine Gilenya not to be used during pregnancy. Update of restrictions - 16.09.2019

Medicines Authority Circular No P15/2019 REMeningioma risk associated with cyproterone medicines: PRAC starts a review - 02.08.2019

Medicines Authority Circular No P14/2019 REEMA recommends the use of bacterial lysate medicines only for prevention of recurrent respiratory infections - 12.07.2019

Medicines Authority Circular No P13/2019 REHandling errors with depot formulations of leuprorelin medicines: PRAC starts a review - 12.07.2019

Medicines Authority Circular No P11/2019 RETyverb: data on use following treatment with trastuzumab re-analysed - 11.06.2019

Medicines Authority Circular No P08/2019 RE: Quinolone and Fluoroquinolone antibiotics: use restricted due to disabling and potentially permanent side effects - 14.05.2019

Medicines Authority Circular No P07/2019 RE: Lartruvo: EMA recommends the withdrawal of the marketing authorisation - 14.05.2019

Medicines Authority Circular No P05/2019 RE: Lemtrada for multiple sclerosis: use restricted while EMA review is ongoing - 23.04.2019

Medicines Authority Circular No P04/2019 RE: Higher doses of Xeljanz for rheumatoid arthritis lead to increased risk of blood clots in lungs and death - 08.04.2019

Medicines Authority Circular No P02/2019 RESartans manufacturing to be reviewed by companies to avoid presence of nitrosamine impurities - 20.02.2019


2018

Medicines Authority Circular No P21/2018 RE: EMA concludes omega-3 fatty acids medicines no longer considered effective in preventing heart disease - 04.01.2019

Medicines Authority Circular No P20/2018 RE: Fosfomycin containing medicinal products: the EMA starts a review- 04.01.2019

Medicines Authority Circular No P19/2018 RE: EMA’s review on Valsartsan-containing products extended to other sartan medicines-05.11.2018

Medicines Authority Circular No P18/2018 RE: PRAC recommends restriction use of quinolones and fluroquinolones-24.10.2018

Medicines Authority Circular No P17/2018 RE: EMA's review on Valsartsan-containing products extended to other sartan medicines-09.10.2018

Medicines Authority Circular No P15/2018 RE:Bacterial lysate medicines for respiratory conditions: EMA's assessment to include recent data on effectiveness-17.07.2018

Medicines Authority Circular No P11/2018 RE: Keytruda use restricted by the EMA because of low survival in some patients with low levels of cancer protein PD-L1-18.06.2018

Medicines Authority Circular No P10/2018 RE: Esmya review conclusions: EMA recommends new measures to minimise the risk of liver injury in treated women -06.06.2018

Medicines Authority Circular No P08/2018 RE: EMA reviewing risk of dosing errors with methotrexate after cases of overdoses continued to be reported-18.06.2018

Medicines Authority Circular No P06/2018 RE: EMA recommends the implementation of new measures to reduce valproate exposure during pregnancy-16.05.2018

Medicines Authority Circular No P05/2018 RE: Retinoid Containing Medicines: Pregnancy prevention recommended in women who start retinoids and prescribing information to be updated with possible risk of neuropsychiatric disorders- 16.05.2018

Medicines Authority Circular No P04/2018 RE: EMA recommends monthly liver function tests for women treated with Esmya- 10.05.2018

2017

Medicines Authority Circular No P20/2017 RE: EMA updates recommendations on contraception for men and women on mycophenolate- 01.02.2018

Medicines Authority Circular No P16/2017 RE: Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between recombinant and plasma-derived products - 12.01.2018

Medicines Authority Circular No P15/2017 RE: Methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins - 29.11.2017

Medicines Authority Circular No P14/2017 RE: Restrictions on use of linear gadolinium agents in body scans confirmed - 08.01.2018

Medicines Authority Circular No P11/2017 RE: EMA recommends changes to prescribing information for vancomycin antibiotics - 10.07.2017

Medicines Authority Circular No P07/2017 RE: EMA starts new review of valproate use in pregnancy and women of childbearing age - 28.03.2017

Medicines Authority Circular No P06/2017 Re: Different nasal spray preparations should not be mixed together. Quality, Safety and Efficacy of such preparations cannot be guaranteed - 13.03.2017

Medicines Authority Circular No P05/2017 RE: Information on potential risk of toe amputation with SGLT2 inhibitors to be included in the prescribing information - 22.03.2017

Medicines Authority Circular No P02/2017 RE: EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics - 22.03.2017


2016

Medicines Authority Circular No P34/2016 Re: EMA reviews direct-acting antivirals for hepatitis C. Recommendation to screen for hepatitis B confirmed but further studies needed to assess risk of liver cancer - 08.02.2017

Medicines Authority Circular No P31/2016 Re: Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function - 08.02.2017

Medicines Authority Circular No P26/2016 Re: CHMP confirms that patients on Zydelig should be monitored for infection and given antibiotics during and after treatment - 11.08.2016

Medicines Authority Circular No P25/2016 Re: Review of factor VIII medicines started - EMA to evaluate risk of developing inhibitors in patients starting treatment for haemophilia A - 12.07.2016

Medicines Authority Circular No P24/2016 Re: EMA starts review of retinoid medicines - Effectiveness of measures for pregnancy prevention and for minimising possible risk of neuropsychiatric disorders to be evaluated12.07.2016

Medicines Authority Circular No P19/2016 Re: EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease - Review finds no differences between products in risk of pneumonia - 02.05.2016

Medicines Authority Circular No P17/2016 Re: EMA reviews diabetes medicine canagliflozin following data on toe amputations in ongoing study - 28.04.2016

Medicines Authority Circular No P16/2016 Re: Update to EMA’s review of direct-acting antivirals for hepatitis C - Scope of review extended to include the risk of liver cancer - 28.04.2016

Medicines Authority Circular No P15/2016 Re: Fusafungine sprays to be withdrawn due to serious allergic reactions and limited evidence of benefit - 28.04.2016

Medicines Authority Circular No P12/2016 Re: Review of vancomycin-containing medicines started - 28.04.2016

Medicines Authority Circular No P10/2016 Re: EMA reviewing gadolinium contrast agents used in MRI scans - Review to consider evidence on gadolinium accumulation in brain tissue - 28.03.2016

Medicines Authority Circular No P09/2016 Re: EMA reviews direct-acting antivirals for hepatitis C - 28.03.2016

Medicines Authority Circular No P05/2016 Re: EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes - 03.03.2016

Medicines Authority Circular No P04/2016 Re: EMA confirms recommendations to minimise risk of brain infection PML with Tysabri - 01.03.2016

Medicines Authority Circular No P03/2016 Re: SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis - 23.02.2016

Medicines Authority Circular No P02/2016 Re: PRAC recommends that fusafungine nose and mouth sprays are no longer marketed - 23.02.2016

Medicines Authority Circular No P01/2016 Re: Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri - 23.02.2016


2015

Medicines Authority Circular No P20/2015 Re: New recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya- 29.12.2015

Medicines Authority Circular No P19/2015 Re: Review of diabetes medicines SGLT2 inhibitors and risk of diabetic ketoacidosis - 28.12.2015

Medicines Authority Circular No P18/2015 Re: Start of review of inhaled corticosteroids for chronic obstructive pulmonary disease - 22.12.2015

Medicines Authority Circular No P17/2015 Re: Review of Tysabri started - 31.12.2015

Medicines Authority Circular No P16/2015 Re: HPV vaccines: Evidence does not support HPV causes CRPS or POTS - 09.12.2015

Medicines Authority Circular No P14/2015 Re: Additional measures recommended preventing use of mycophenolate in pregnancy  -09.11.2015

Medicines Authority Circular No P13/2015 Re: Updated advice on HIV medicines -09.11.2015

Medicines Authority Circular No P12/2015 Re: Review of nasal and mouth sprays containing fusafungine started  - 15.09.2015

Medicines Authority Circular No P09/2015 Re: PRAC referral started to further clarify safety profile of human papillomavirus (HPV) vaccines  - 25.08.2015

Medicines Authority Circular No P07/2015 Re: PRAC recommends updating advice on use of high-dose ibuprofen for systemic use- 28.04.2015

Medicines Authority Circular No P06/2015 Re: PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonates 16.04.2015

Medicines Authority Circular No P05/2015 Re: New restrictions to minimise risks with hydroxyzine confirmed by CMDh-15.04.2015

Medicines Authority Circular No P04/2015 Re: EMA recommends restrictions on the use of codeine for cough & cold in children - 16.03.2015

Medicines Authority Circular No P03/2015 Re: Product information for Ambroxol and Bromhexine expectorants to be updated  -02.03.2015

Medicines Authority Circular No P02/2015 Re: PRAC recommends new measures to minimise cardiovascular side effects of hydroxyzine containing medicines (Atarax®) -16.02.2015


2014

Medicines Authority Circular No P28/2014 Re: European Medicines Agency finalises review on Procoralan (ivabradine) and recommends measures to reduce the risk of heart problems - 28.12.2014

Medicines Authority Circular No P25/2014 Re: PRAC review does not confirm increase in heart problems with Testosterone medicines - 23.09.2014

Medicines Authority Circular No P24/2014 Re: PRAC recommends strengthening the restrictions on the use of Valproate containing products in women and girls - 23.09.2014

Medicines Authority Circular No P23/2014 Re: CMDh endorses restricted use of bromocriptine for stopping breast milk production  - 23.09.2014

Medicines Authority Circular No P22/2014 Re: Start of review of Ibuprofen medicines when taken in high dose over long periods  - 19.08.2014

Medicines Authority Circular No P21/2014 Re: Suspension of Methadone oral solutions containing high molecular weight povidone - 31.07.2014

Medicines Authority Circular No P19/2014 Re: Review of Atarax (hydroxyzine containing medicines) started - 26.06.2014

Medicines Authority Circular No P18/2014 Re: Review of Procorolan started  - 16.06.2014

Medicines Authority Circular No P13/2014 Re: Review of Ambroxol and Bromhexine containing products started  - 26.05.2014

Medicines Authority Circular No P12/2014 Re: Review of Testosterone containing products started  - 23.05.2014

Medicines Authority Circular No P11/2014 Re: Review of oral Methadone medicines containing povidone started  - 05.05.2014

Medicines Authority Circular No P10/2014 Re: Stolen Herceptin, Alimta and Remicade vials reintroduced illegally in some EU markets but not Malta - 05.05.2014

Medicines Authority Circular No P09/2014 Re: Recommendation against combined use of medicines affecting the Renin-Angiotensin System - 30.04.2014

Medicines Authority Circular No P08/2014 Re: Recommendation to restrict the use of domperidone confirmed by CMDh - 29.04.2014

Medicines Authority Circular No P06/2014 Re: Recommendation to restrict the use of domperidone - 17.03.2014

Medicines Authority Circular No P05/2014 Re: Product information of Zolpidem to be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness - 17.03.2014

Medicines Authority Circular No P04/2014 Re: Protelos (stronitium ranelate) will remain available but with further restrictions - 28.02.2014

Medicines Authority Circular No P03/2014 Re: Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels - 02.01.2014

Medicines Authority Circular No P02/2014 Re: Recommendation to restrict the use of thiocolchicoside by mouth or injection -02.01.2014

Medicines Authority Circular No P01/2014 Re: Company Led Medicinal Product Recall of Parallel Imported Nurofen® Zatoki - 02.01.2014

 

2013

Medicines Authority Circular No P29/2013 Re: Benefits continue to outweigh risks of using Kogenate Bayer/Helixate NexGen in previously untreated patients - 31.12.2013

Medicines Authority Circular No P27/2013 Re: Outcome of review of Combined Hormonal Contraceptives (CHCs) results in an opinion to update the product information to help women make informed decisions about their choice of contraception - 31.12.2013

Medicines Authority Circular No P26/2013 Re: Start of review of valproate sodium and related substances- 07.11.2013

Medicines Authority Circular No P25/2013 Re: Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients- 30.10.2013

Medicines Authority Circular No P24/2013 Re: Restrictions on use of short acting beta agonists in obstetric indications - CMDh endorses PRAC recommendations- 31.10.2013

Medicines Authority Circular No P23/2013 Re: Changes to the use of Metoclopramide to reduce the risk of neurological side effects- 07.11.2013

Medicines Authority Circular No P22/2013 Re: Review of zolpidem containing medicinal products started - 02.10.2013

Medicines Authority Circular No P21/2013 Re:Start of review of bromocriptine in preventing or suppressing lactation - 25.09.2013

Medicines Authority Circular No P20/2013 Re: Short-acting beta agonist tablets and suppositories should no longer be used in obstetric indications- 20.09.2013

Medicines Authority Circular No P19/2013 Re: Numeta G13%E to be suspended and new risk minimisation measures to be introduced for Numeta G16%E- 20.09.2013

Medicines Authority Circular No P18/2013 Re: European Medicines Agency recommends the suspension of Nizoral tablets- 25.07.2013

Medicines Authority Circular No P17/2013 Re: Review of Numeta G13%E and G16%E started- 20.07.2013

Medicines Authority Circular No P16/2013 Re: European Medicines Agency recommends the suspension of infusion solutions containing Hydroxyethyl Starch- 18.07.2013

Medicines Authority Circular No P15/2013 Re: New recommendations to manage risk of allergic reactions with intravenous iron-containing medicines - 11.07.2013

Medicines Authority Circular No P14/2013 Re: Restrictions on the use of codeine for pain relief in children - 05.07.2013

Medicines Authority Circular No P13/2013 Re: New safety advice for diclofenac to minimise cardiovascular risk - 1.07.2013

Medicines Authority Circular No P12/2013 Re: EMA recommends restricting Trobalt® to last line therapy in partial epilepsy - 05.06.2013 

Medicines Authority Circular No P11/2013 Re: Update on the European Medicines Agency's safety review on Diane-35 and generics - 20.05.2013

Medicines Authority Circular No P10/2013 Re: Recommendation to restrict the use of Protelos/Osseor (strontium ranelate) - 29.04.2013

Medicines Authority Circular No P09/2013 Re:Suspension of Miacalcic; nasal spray and recommendations to limit the long-term use of calcitonin medicines - 26.03.2013

Medicines Authority Circula No P08/2013 Re:  Review of Kogenate Bayer/Helixate NexGen started - 13.03.2013

Medicines Authority Circular No P07/2013 Re: European Medicines Agency starts review of domperidone containing medicinal products and ANNEX 1- 13.03.2013

Medicines Authority Circular No P06/2013 Re: European Medicines Agency starts safety review of Diane-35 and its generics - 13.03.2013

Medicines Authority Circular No P05/2013 Re: European Medicines Agency starts review of third and fourth generation combined oral contraceptives - 9.02.2013 

Medicines Authority Circular No P04/2013 Re: Review of Hydroxyethyl-starch containing solutions for infusion started - 18.01.2013

Medicines Authority Circular No P03/2013 Re: European Medicines Agency on the cardiovascular safety of diclofenac compared to other NSAIDs - 18.01.2013  P03/2013 ANNEX

Medicines Authority Circular No P02/2013 Re: European Medicines Agency starts review of Short acting Beta-2-Agonists - 18.01.2013

Medicines Authority Circular No P01/2013 Re: European Medicines Agency recommends the suspension of nicotinic acid/laropiprant medicinal products - Tredaptive, Pelzont and Trevaclyn - 16.01.2013

 

2012

Medicines Authority Circular No P15/2012 Re: Review of Codeine-containing products started -11.11.2012

Medicines Authority Circular No P14/2012 Re: Recommendation to restrict the use of Trimetazidine-containing medicinal products - 28.06.2012

Medicines Authority Circular No P13/2012 Re: Advice to prescribers treating patients with Doribax for nosocomial pneumonia- 28.06.2012 

Medicines Authority Circular No P12/2012 Re: Positive benefit-risk balance of MabThera confirmed by European Medicines Agency - 27.06.2012

Medicines Authority Circular No P11/2012 Re: Recommendation for the update of patient and prescriber information for Pradaxa - 14.06.2012

Medicines Authority Circular No P10/2012 Re: European Medicines Agency gives new advice to better manage risk of adverse effects on the heart with Gilenya - 24.04.2012

Medicines Authority Circular No P09/2012 Re: European Medicines Agency confirms positive benefit-risk balance of Protelos/Osseor, but recommends new contraindications and revised warnings - 20.03.2012

Medicines Authority Circular No P08/2012 Re: European Medicines Agency gives final recommendations on the medicines manufactured at Ben Venue Laboratories - 17.03.2012

Medicines Authority Circular No P07/2012 Re: Supply shortage of Vfend (voriconazole) - 13.03.2012

Medicines Authority Circular No P06/2012 Re: European Medicines Agency confirms positive benefit-risk balance of orlistat-containing medicines- 20.02.2012

Medicines Authority Circular No P05/2012 Re: European Medicines Agency recommends lifting of the suspension of aprotinin- 20.02.2012

Medicines Authority Circular No P04/2012 Re: European Medicines Agency reviews dose recommendations for anti-tuberculosis medicines used in children- 20.02.2012

Medicines Authority Circular No P03/2012 Re: European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines - 20.02.2012

Medicines Authority Circular No P02/2012 Re: European Medicines Agency starts review of Gilenya (fingolimod) - 23.01.2012

Medicines Authority Circular No P01/2012 Re: European Medicines Agency gives recommendations to prevent administration errors with Velcade (bortezomib) - 23.01.2012 

 

2011

Medicines Authority Circular No P21/2011 Re: European Medicines Agency starts review of aliskiren-containing medicines following termination of the ALTITUDE study - 27.12.2011

Medicines Authority Circular No P20/2011 Re: European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines - 20.12.2011

Medicines Authority Circular No P19/2011 Re: European Medicines Agency updates on safety of Pradaxa - 18.12.2011 

Medicines Authority Circular No P18/2011Re: European Medicines Agency confirms positive benefit-risk balance of pholcodine-containing cough medicines - 18.12.2011 

Medicines Authority Circular No P17/2011Re: Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy - 26.10.2011

Medicines Authority Circular No P16/2011 RE: European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs- 27.10.2011 

Medicines Authority Circular No P15/2011 Re: European Medicines Agency concludes that benefit-risk balance of angiotensin II receptor antagonists remains positive - 27.10.2011 

Medicines Authority Circular No P14/2011 Re: Review of the Benefit-Risk ratio of Protelos and Osseor has started at the European Medicines Agency- 27.10.2011

Medicines Authority Circular No P13/2011 Re: European Medicines Agency concludes that benefit-risk balance with Revlimid remains positive - 4.10.2011

Medicines Authority Circular No P12/2011 Re: European Medicines Agency starts review of orlistat-containing medicines - 4.10.2011

Medicines Authority Circular No P11/2011 Re: European Medicines Agency recommends restricting the use of Multaq - 30.09.2011

Medicines Authority Circular No P09/2011 Re: European Medicines Agency confirms positive benefit-risk balance for Champix with the benefits of smoking cessation outweighing slight reported increase in cardiovascular events - 30.09.2011

Medicines Authority Circular No P08/2011 Re: European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer - 30.09.2011

Medicines Authority Circular No P07/2011 Re: A European review of Pioglitazone-containing medicines - 9.06.2011

Medicines Authority Circular No P06/2011 Re: European Medicines Agency finalises review of bisphosphonates and atypical stress fractures - 7.06.2011

Medicines Authority Circular No P05/2011 Re: European Medicines Agency concludes its evaluation on use of celecoxib in familial adenomatous polyposis - 27.05.2011

Medicines Authority Circular No P04/2011 Re: European Medicines Agency recommends lifting of suspension of Octagam - 19.04.2011

Medicines Authority Circular No P02/2011 Re: European Medicines Agency's review makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents - 29.01.2011

Medicines Authority Circular No P01/2011 Re: European Medicines Agency's review of the manufacture of Baxter's peritoneal dialysis solutions initiated over potential presence of endotoxins in some batches- 29.01.2011

 

2010

Medicines Authority Circular No P19/2010 Re: European Medicines Agency starts review of Somatropin containing medices - 16.12.2010

Medicines Authority Circular No P17/2010 Re: European Medicines Agency  confirms that presence of unexpected viral DNA in live attenuated vaccines does not raise public health concerns- 20.11.2010

Medicines Authority Circular No P16/2010 Re: European Medicines Agency reviews treatment recommendations for Fabrazyme  - 27.10.2010

Medicines Authority Circular No P15/2010 Re: European Medicines Agency recommends use of fibrates as second-line treatment - 27.10.2010

Medicines Authority Circular No P14/2010 Re: European Medicines Agency concludes that the risk of invirase remains positive - 27.10.2010

Medicines Authority Circular No P12/2010 Re: European Medicines Agency recommends suspension of Octagam in all EU member states - 24.09.2010

Medicines Authority Circular No P11/2010 Re: European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim - 24.09.2010

Medicines Authority Circular No P10/2010 Re: European Medicines Agency concludes review of modified-release oral opioids of the WHO level III scale for the management of pain - 4.08.2010

Medicines Authority Circular No P09/2010 Re: European Medicines Agency recommends restricting the use of modafinil for the treatment of narcolepsy only; all other indications to be removed from product information- 2.08.2010

Medicines Authority Circular No P08/2010 Re: European Medicines Agency confirms positive benefit-risk balance of topical formulations of ketoprofen - 27.07.2010

Medicines Authority Circular No P07/2010 Re: European Medicines Agency update on ongoing benefit risk review of Avandia, Avandamet and Avaglim - 27.07.2010

Medicines Authority Circular No P05/2010 Re: European Commission Decision on marketing authorisations of medicinal authorisations of medicinal product for human use which contain the active substance dextropoxyphene - 19.07.2010

Medicines Authority Circular No P04/2010 Re: European Medicines Agency sees no safety concerns with the Rotarix oral vaccine - 6/4/2010

Medicines Authority Circular No P03/2010 Re: European Medicines Agency update warning for the interaction between clopidogrel and proton-pump inhibitors - 6/4/2010

Medicines Authority Circular No P02/2010 Re: European Medicines Agency recommends additional measures to better manage risk of progressive multifocal leukoencephalopathy (PML) with Tysabri - 22.01.10

Medicines Authority Circular No P01/2010 Re: European Medicines Agency recommends suspension of marketing authorisations for sibutramine - 22.01.10

2009 

Medicines Authority Circular No P14/2009 Re: European Medicines Agency updates on ongoing safety review of sibutramine - 18.12.2009 

Medicines Authority Circular No P13/2009 Re: European Medicines Agency second update on safety of insulin glargine - 23.07.2009

Medicines Authority Circular No P10/2009 Re: European Medicines Agency update on safety of insulin glargine - 01.07.2009

Medicines Authority Circular No P09/2009 Re:  Possible interaction between clopidogrel and proton pump inhibitors - 15.06.2009

Medicines Authority Circular No P08/2009  Re: New advice on oral salicylate gels in under 16s - 24.04.2009

Medicines Authority Circular No P07/2009 Re: Abacavir and the risk of heart attack - Update - 24.04.2009

Medicines Authority Circular No P06/2009 Re: Use of over-the-counter cough and cold medicines in children - Update- 02.03.2009

Medicines Authority Circular No P05/2009 Re: The EMEA recommends continued vaccination with Gardasil - 19.02.2009

Medicines Authority Circular No P04/2009 Re: The EMEA recommends new contraindication and warning for Rasilez and other aliskiren medicines - 19.02.2009

Medicines Authority Circular No P03/2009 Re: The EMEA recommends suspension of the marketing authorisation of Raptiva (efalizumab) - 19.02.2009

Medicines Authority Circular No P02/2009 Re: The EMEA recommends new contraindications for Fareston (toremifene) - 23.01.2009

Medicines Authority Circular No P01/2009 Re: The EMEA makes recommendations for safer use of Ritalin and other methylphenidate-containing medicines in the EU - 23.01.2009

 

2008

Medicines Authority Circular No P11/2008 Re: The EMEA recommends the suspension of the marketing authorisation of Acomplia - 22.10.2008

Medicines Authority Circular No P10/2008 Re: EMEA recommends update of product information of Tysabri and risk of progressive multifocal leukoencephalopathy (PML) - 26.09.2008 

Medicines Authority Circular No P08/2008 Re: Use of Angiotensin II Receptor Inhibitors during Pregnancy - 02.05.2008

Medicines Authority Circular No P07/2008 Re: Further data needed to determine risk of heart attack with abacavir - 09.04.2008

Medicines Authority Circular No P06/2008 Re: EMEA concludes new advice to doctors and patients for Tysabri (natalizumab) needed - 09.04.2008

Medicines Authority Circular No P05/2008 Re: EMEA recommendation of a new contraindication for Velcade (bortezomib) - 09.04.2008

Medicines Authority Circular No P04/2008 Re: Over-the-counter cough and cold medicines for children

Medicines Authority Circular No P03/2008 Re: New warnings and contraindications for rosiglitazone - 25.01.2008

Medicines Authority Circular No P02/2008 Re: Safety of Gardasil® (quadrivalent human papillomavirus vaccine) - 25.01.2008

Medicines Authority Circular No P01/2008 Re: Recommendation for the Withdrawal of the Marketing Authorisation of Lumiracoxib-containing medicines- 10.01.2008

 

2007

Medicines Authority Circular No P19/2007 Re: Suspension of the Marketing Authorisation of Aprotinin-containing medicines for systemic use - 22.11.2007

Medicines Authority Circular No P18/2007 Re: Benefit Risk Balance of Prexige® (lumiracoxib) - 22.11.2007 (Attachment)

Medicines Authority Circular No P18/2007 Re: Benefit Risk Balance of Prexige® (lumiracoxib) - 22.11.2007

Medicines Authority Circular No P17/2007 Re: Suspension of marketing authorisations for carisoprodol-containing medicinal products- 20.11.2007

Medicines Authority Circular No P16/2007 Re: Protelos/Osseor® (Strontium ranelate) and severe hypersensitivity reactions- 20.11.2007

Medicines Authority Circular No P15/2007 Re: Benefit-Risk Profile of Avandia (rosiglitazone) and Actos (pioglitazone) - 19.10.2007

Medicines Authority Circular No P14/2007 Re: Benefit-Risk Profile of Clobutinol-containing Medicinal Products- 19.10.2007

Medicines Authority Circular No P13/2007 Re: Benefit-Risk Profile of Nimesulide-containing Systemic Medicinal Products - 25.09.2007

Medicines Authority Circular No P12/2007 Re: Lifting of Suspension of the Marketing Authorisation for Viracept® (nelfinavir) - 25.09.2007

Medicines Authority Circular No P11/2007 Re: Suspension of the Marketing Authorisation for Viracept® (nelfinavir) - 07.08.2007

Medicines Authority Circular No P10/2007 Re: Withdrawal of Veralipride-containing Medicinal Products - 24.07 .2007

Medicines Authority Circular No P09/2007 Re: Risk of Psychiatric Side-effects associated with the Use of Acomplia (Rimonabant) - 20.07 .2007

Medicines Authority Circular No P08/2007 Re: Benefit Risk Profile of Systemic Piroxicam - 20.07.2007

Medicines Authority Circular No P07/2007 Re: Suspension of the Marketing Authorisation for Viracept® (nelfinavir) - 26.06.2007

Medicines Authority Circular No P06/2007 Re: Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim).

Medicines Authority Circular No P05/2007 Re: Safety of Dopamine Agonists - 05.04.2007

Medicines Authority Circular No P04/2007 Re: Outcome on Benefit/Risk Review of Safety of Ketek® (telithromycin). - 03.04.2007

Medicines Authority Circular No P03/2007 Re: European Medicines Agency statement on safety of Tamiflu - 23.03.2007

Medicines Authority Circular No P02/2007 Re: Pergolide and the risk of cardiac valvulopahty and fibrotic reactions.-  15.02.2007

Medicines Authority Circular No P01/2007 Re: Follow-up Information on the Safety of Trasylol® (Aprotinin) - 01.02.2007

2006

Medicines Authority Circular No P11/2006 Re: Outcome on Review of Cardiovascular Safety of Non-selective NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) - 25.10.2006

Medicines Authority Circular No P10/2006 Re: Licensed therapeutic indications for Navidoxine 25mg tablets (Meclozine hydrochloride) - 17.08.2006

Medicines Authority Circular No P09/2006 Re: Serious Hepatic Reactions associated with herbal medicinal products containing Cimicifugae Racemosae Rhizoma (Black Cohosh) -07.08.2006

Medicines Authority Circular No P08/2006 Re: Update on Prozac® (fluoxetine) and indication in children - 09.06.2006

Medicines Authority Circular No P07/2006 Re: Precautions on the use of Elidel® (pimecrolimus) and Protopic®/Protopy® (tacrolimus) - 04.04.2006

Medicines Authority Circular No P06/2006 Re: Update on Herceptin® (trastuzumab) - 27.03.2006

Medicines Authority Circular No P05/2006 Re: Albumin Therapy in Critically-ill Patients - 20.03.2006

Medicines Authority Circular No P04/2006 Re: Isotretinoin-containing medicinal products - 20.03.2006

Medicines Authority Circular No P03/2006 Re: Recent Study on Safety of Trasylol® (Aprotinin) - 06/02/2006

Medicines Authority Circular No P02/2006 Re: Safety of Ketek (telithromycin) - 30/01/2006

Medicines Authority Circular No P01/2006 Re: Phenylpropanolamine (PPA) in medicinal products - 25/01/2006

2005

Medicines Authority Circular No P21/2005 Re: Tamiflu Safety Information - 15/12/2005

Medicines Authority Circular No P20/2005 Re: Safety of Tamiflu (oseltamivir) - 22/11/2005

Medicines Authority Circular No P19/2005 Re: Cardiovascular and gastointestinal safety and serious skin reactions with non-selective NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) - 04/11/2005

Medicines Authority Circular No P16/2005 Re: Hexavac and concerns regarding decreased long-term protection against hepatitis B - 20/09/2005

Medicines Authority Circular No P15/2005 Re: Non-Selective NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) and Cardiovascular Safety - 02/08/2005

Medicines Authority Circular No P14/2005 Re: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and their recent association with an increased risk of myocardial infarction (heart attack).  Statement in EnglishVerżjoni ta'stqarrija bil-Malti.

Questions and Answers regarding Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and their recent association with an increased risk of myocardial infarction (heart attack).

Medicines Authority Circular No P12/2005 Re: Ongoing European and national review of atypical antipsychotics and their association with an increased risk of cerebrovascular adverse events (CVA) in elderly patients with dementia - 17/05/2005

Medicines Authority Circular No P11/2005 Re: Finalisation of Review of Serotonin-Selective Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)

Medicines Authority Circular No P10/2005 Re: Suspension of Bextra® (valdecoxib)as an Interim Measure

Medicines Authority Circular No P09/2005 Re: Quinine and the Risk of Thrombocytopenia

Medicines Authority Circular No P03/2005 Re: COX-2 Inhibitors Statement:- English/Malti

Medicines Authority Circular No P02/2005 Re: Compound Preparations containingDextropropoxyphene and Paracetamol (Co-proxamol) and its indication for mild to moderate pain  

Medicines Authority Circular No P01/2005 Re: Forthcoming Withdrawal of Thioridazine-containing Medicinal Products

Medicines Authority Update No PLU04/2005: Products containing Glucosamine

Medicines Authority Update No PLU03/2005: Ongoing review of COX-2 inhibitors, by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)

Medicines Authority Update No PLU02/2005: VALDECOXIB (Bextra®/Valdyn®) and PARECOXIB SODIUM (Dynastat®/Rayzon®) and cardiovascular safety  

Medicines Authority Update No PLU01/2005: Celecoxib (Celebrex®) and cardiovascular safety

 

2004

Medicines Authority Update No PLU04/2004: Ritonovir

Medicines Authority Update No PLU03/2004: Implanon®: Europe adopts the Dutch position - Implanon® still safe and effective

Medicines Authority Update No PLU02/2004: Extraordinary meeting of the European Medicines Agency (EMEA) scientificm committee, the Committee for Medicinal Products for Human use (CHMP) held on 8 December 2004 on selective serotonin re-uptake inhibitors (SSRIs) and serotonin and norepinephrine re-uptake inhibitors (SNRIs) and their use in children and adolescents.

Questions & Answers Regarding Cox-2 Inhibitors

Medicines Authority Update No PLU01/2004: Worldwide Withdrawal of Vioxx (Rofecoxib). Verżjoni ta'stqarrija bil-Malti

Vioxx - Questions and Answers