| Apretude/Cabotegravir, HCP educational brochure |
12/12/2024 |
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| Apretude/Cabotegravir, HCP checklist |
12/12/2024 |
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| Apretude/Cabotegravir, patient educational brochure |
12/12/2024 |
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| Apretude/Cabotegravir, patient appointment reminder card |
12/12/2024 |
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| DHCPL, Salbutamol |
11/06/2025 |
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| Salbutamol pMDI, Risk Awareness Dialogue Aid |
01/04/2026 |
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| DHCPL, Dutasteride |
30/10/2025 |
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Important safety information on vaccines in Ukraine
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10/10/2018
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Important safety information on Seretide in Ukraine
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10/10/2018
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Important safety information on Dolutegravir in Ukraine
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10/10/2018
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| Important safety information on Abacavir: Hypersensitivity reaction - educational slide deck |
08/04/2026 |
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| Important safety information on Volibris in Ukraine (Information for Healthcare Professionals) |
14/04/2026 |
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| Important safety information on Volibris in Ukraine (Patient booklet) |
14/04/2026 |
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| Important safety information on Volibris in Ukraine (Memo for female patients taking Volibris) |
14/04/2026 |
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| Important safety information on Volibris in Ukraine (Information for male partners of women taking Volibris) |
14/04/2026 |
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| Reminder information for patients taking Volibris (Reminder card) |
14/04/2026 |
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Important safety information on Amoxicillin / Amoxicillin and clavulanic acid containing products in Ukraine |
09/09/2023 |
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| Important safety information on Lamotrigine containing products in Ukraine |
09/09/2023 |
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| Important safety information on Paroxetine containing products in Ukraine |
27/10/2023 |
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| Important safety information on Dolutegravir containing products in Ukraine (Safety Notification_Korean label update for Dolutegravir containing products) |
31/10/2023 |
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| Important safety information on Topical Corticosteroids containing products in Ukraine |
20/11/2023 |
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| Important safety information on Hepatitis B surface antigen recombinant vaccine in Ukraine (Initial Safety Notification Engerix-B and Myelitis_November 2023) |
20/11/2023 |
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| Important safety information on Hepatitis B surface antigen recombinant vaccine in Ukraine (Updated Safety Notification Engerix-B and Myelitis_December 2023) |
27/12/2023 |
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Important safety information on Amoxicillin/clavulanic acid containing products - MedSafe communication regarding labelling updates |
18/12/2023 |
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Important safety information on Zanamivir containing products - Precautions for prescribing and administering flu medications (zanamivir) |
22/12/2023 |
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Important safety information on Paroxetine containing products - Modifications of the information of medicines authorized by national procedure that contain Paroxetine |
22/12/2023 |
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Important safety information on Acyclovir containing products - Safety Notification EMA-PRAC: The MAH has been requested to provide cumulative reviews of the below-mentioned issues in the next PBRER to be submitted for acyclovir |
02/01/2024 |
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Important safety information on Dolutegravir containing products - Dolutegravir and sexual dysfunction |
11/01/2024 |
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Important safety information on Hepatitis B surface antigen recombinant vaccine (Updated Safety Notification Engerix-B and Myelitis_January 2024_1st upd) |
08/01/2024 |
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Important safety information on Hepatitis B surface antigen recombinant vaccine (Updated Safety Notification Engerix-B and Myelitis_January 2024_2nd upd) |
26/01/2024 |
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| Important safety information on Lamotrigine containing products - SAHPRA Letter, Risk of pseudolymphoma(s) |
15/03/2024 |
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Important safety information on Lamotrigine containing products - Safety Signal received from Swissmedic: Lamictal - Interaction with hormone replacement therapies (HRT) |
18/03/2024 |
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Important safety information on Lamotrigine containing products - El Salvador safety alert-LAMICTAL 5 mg, LAMICTAL 25 mg, LAMICTAL 50 MG, LAMICTAL 100 MG |
18/03/2024 |
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Important safety information on Valaciclovir containing products - Adaptation of the medicinal product information for Valaciclovir containing products |
18/03/2024 |
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Important safety information on Umeclidinium bromide/vilanterol trifenatate containing products - Minutes from French HA (ANSM) meeting / signal for umeclidinium bromide/vilanterol trifenatate (ANORO) |
20/03/2024 |
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Important safety information on Lamotrigine containing products - Safety Signal received from Swissmedic: Lamictal - Interaction with hormone replacement therapies (HRT), updated information, April 2024 |
05/04/2024 |
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Important safety information on Amoxicillin/clavulanic acid containing products - Drug-induced gastroenteritis syndrome |
10/04/2024 |
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Important safety information on Acyclovir containing products - ACYCLOVIR/VALACYCLOVIR – RISK OF DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS) |
17/04/2024 |
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Important safety information on Paroxetine containing products - Modifications of the information of medicines authorized by national procedure that contain: PAROXETINE, updated information, April 2024 |
19/04/2024 |
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Important safety information on Hepatitis B surface antigen recombinant vaccine - Updated Safety Notification Engerix-B and Myelitis_May 2024 |
07/05/2024 |
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| Important safety information on β Lactam class, Amoxicillin/clavulanic acid - risk of linear IgA |
25/05/2024 |
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| Important safety information on β Lactam class, Amoxicillin/clavulanic acid - risk of Kounis syndrome |
25/05/2024 |
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| Important safety information on Valaciclovir - Signal Assessment Report on acute hepatitis - PRAC recommendation |
18/06/2024 |
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| Important safety information on Lamotrigine containing products - SAHPRA Letter, Risk of pseudolymphoma(s) - Updated, July 2024 |
11/07/2024 |
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| Important safety information on Lamotrigine containing products - El Salvador safety alert, Updated, July 2024 |
12/07/2024 |
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| Important safety information on Lamotrigine containing products - MedSafe, Updated, July 2024 |
12/07/2024 |
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| Important safety information on Lamotrigine - Risk re-assessment of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) ) in association with specific gene, such as HLA-B*1502 |
16/08/2024 |
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| Important safety information on Salbutamol - Request for further review in the next PBRER, hypomagnesaemia |
23/08/2024 |
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| Important safety information on Bexsero - Request for further review in PBRER assessment report, vasculitis including Kawasaki disease |
13/09/2024 |
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| Important safety information on Lamotrigine - Risk of erytherma multiforme and pseudolymphoma and request to provide the outcome of the cumulative review for the risk of photosensitivity |
19/09/2024 |
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| Important safety information on Cabotegravir (HIV treatment) - Final Assessment Report including request to update the label-Stevens-Johnson syndrome (SJS) ,toxic epidermal necrolysis (TEN), Gait disturbance |
11/10/2024 |
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| Important safety information on Cabotegravir (PrEP) - Final Assessment Report including request to update the label-Stevens-Johnson syndrome (SJS) ,toxic epidermal necrolysis (TEN), Gait disturbance |
11/10/2024 |
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| Important safety information on Rotarix - ANSM, Gastroenteritis and vomiting |
15/10/2024 |
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| Important safety information on Engerix B - Request to add Multiple sclerosis, Myelitis, including transverse myelitis, Optic neurite and Guillain-Barré syndrome |
30/10/2024 |
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| Important safety information on Aciclovir - EMA, Cumulative review of “SCARs (including AGEP, DRESS, SJS and TEN) and risk of aciclovir resistance in herpetic keratis |
27/01/2025 |
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| Important safety information on Lamotrigine - JFDA, Request to update the label |
07/02/2025 |
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| Important safety information on Paroxetine - FDA, NISS: SSRIs, SNRIs, TCAs, MAOIs, or norepinephrine and dopamine reuptake inhibitors (NDRIs) and cataplexy |
11/02/2025 |
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| Important safety information - Request for supplementary information and analyses for signal of morphoea after Engerix B and Twinrix |
09/07/2025 |
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| Important safety information on Azole antifungals - Risk communication on vincristine and potential risks of interaction with azole antifungals |
23/07/2025 |
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| Important safety information on Varilrix, Priorix Tetra - EMA, SSI: Final PRAC signal assessment report on new aspect of the known risk of encephalitis with varicella vaccine (live), label update request for Varilrix and Priorix Tetra |
31/07/2025 |
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| Important safety information on Valaciclovir - FDA, Request for label update |
13/08/2025 |
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| Important safety information on Salbutamol - MHRA, Request for label update |
29/09/2025 |
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| Important safety information on Salbutamol - information to further support appropriate patient use to mitigate the potential risk of inadvertent use of an empty salbutamol pressurized metered dose inhalers (pMDIs) |
31/10/2025 |
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| Important safety information on Engerix B - EMA, Request to update the label in PBRER Final Assessment Report |
06/11/2025 |
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| Important safety information on Aciclovir and Valacyclovir - Risks of acute generalized exanthematous pustulosis (AGEP) |
20/01/2026 |
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| Important safety information on Paroxetine - Chest discomfort, Chest pain |
25/02/2026 |
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| Important safety information on Lamotrigine - GSK initiated GDS update regarding risk of SJS/TEN in patients with specific gene (HLA-B*1502) |
16/03/2026 |
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| Important safety information on Lamotrigine - Request to update the label |
16/03/2026 |
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| Important safety information on Umeclidinium bromide / Vilanterol - Request to update the label |
24/04/2026 |
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