DHPC and safety information
Direct healthcare professional communications (DHPC) are used to inform healthcare professionals about any important new safety information regarding a medicine, and any actions they should take to limit potential risks associated with its use. DHPCs are important in promoting the correct use of medicines. They are issued by pharmaceutical laboratories after prior approval and subject to the authority of the Health Directorate and/or the European Medicines Agency (EMA).
These DHPCs and safety information for doctors and pharmacists are available below:
2026
- Leqembi®▼ (lecanemab) 100 mg/mL solution for dilution for infusion: (Pdf, 333 Kb) Update to the magnetic resonance imaging (MRI) schedule to include an MRI scan prior to the third infusion of LEQEMBI | 01.2026
- VENTOLIN (salbutamol) suspension for inhalation in pressurised canister: (Pdf, 329 Kb) reminder regarding the number of doses available per inhaler | 19.01.2026
2025
- Tegretol® 2% syrup (carbamazepine 100 mg/5ml): (Pdf, 369 Kb) restricted use in newborns due to exceeding the recommended threshold for propylene glycol (excipient) concentration | 24.12.2025
- Nimbex (cisatracurium), Tracrium (atracurium), Mivacron (mivacurium) (Pdf, 205 Kb): Possible presence of small glass particles, visible or invisible, in certain batches | 11.11.2025
- Libtayo® (cemiplimab) 350 mg solution for dilution for infusion: (Pdf, 277 Kb) The batch number and expiry date may become illegible after disinfecting and wiping the bottle label | 10.11.2025
- Mivuxin 5 micrograms/ml (noradrenaline) solution for injection/infusion (Pdf, 483 Kb): marketing of a new proprietary medicinal product | 06.11.2025
- Crysvita (burosumab): (Pdf, 225 Kb) Risk of severe hypercalcaemia | 13.10.2025
- Caspofungin: (Pdf, 363 Kb) Avoid using polyacrylonitrile membranes during continuous renal replacement therapy | 09.10.2025
- IXCHIQ®, chikungunya vaccine (live, attenuated) (Pdf, 585 Kb): removal of temporary contraindication in adults aged 65 years and older; warning regarding serious adverse reactions, including encephalitis | 19.09.2025
- Crysvita (burosumab): (Pdf, 225 Kb) Risk of severe hypercalcaemia | 13.10.2025
- Caspofungin: (Pdf, 363 Kb) Avoid using polyacrylonitrile membranes during continuous renal replacement therapy | 09.10.2025
- Finasteride, Dutasteride (Pdf, 158 Kb): New measures to minimise the risk of suicidal thoughts | 10.09.2025
- Leponex® (clozapine) (Pdf, 282 Kb): Revised recommendations for regular monitoring of blood counts due to the risk of agranulocytosis | 08.09
- Rapamune (sirolimus) 1 mg/ml, 60 ml oral solution: (Pdf, 878 Kb) restriction on the use of the batches concerned due to a discrepancy between the expiry dates indicated on the syringe adapter and on the oral solution | 08.09.2025
- Delamoxyle® (amoxicillin) (Pdf, 310 Kb): Quality defect concerning the package leaflet for Delamoxyle 1g, powder for solution for injection/infusion | 25.08.2025
- Evrysdi 0.75 mg/ml powder for oral solution (risdiplam)▼ (Pdf, 275 Kb): Omission of mandatory information on the labelling and summary of product characteristics in the EU | 21.08.2025
- Mysimba (naltrexone/bupropion) (Pdf, 70 Kb): long-term cardiovascular risk and new recommendations on annual assessment | 28.05.2025
- Fastum gel 2.5% (ketoprofen) (Pdf, 76 Kb): measures to minimise the risks associated with topical ketoprofen formulations | 27.05
- Kisqali® (ribociclib) (Pdf, 248 Kb): change in storage precautions and shelf life | 23.05.2025
- Ixchiq vaccine (chikungunya vaccine (live)) (Pdf, 716 Kb): new contraindication in patients aged 65 years and older, while an EU-wide review is ongoing | 22.05.2025
- Opzelura® 15 mg/g, cream (ruxolitinib phosphate) (Pdf, 416 Kb): Important information regarding presence of particles in Opzelura cream | 24 April 2025
- Depakine I.V. 400 mg/4 ml powder and solution for injection or infusion (Pdf, 221 Kb): Updated summary of product characteristics (SPC) and leaflet with corrected instructions for reconstituting the solution | 22 April 2025
- Progestins (Pdf, 287 Kb): Risk of meningioma – surveillance data | 9 April 2025
- Levonorgestrel-releasing intrauterine delivery systems (IUDs) (Mirena®, Jaydess®, Levonortis®, Levosert®) (Pdf, 492 Kb): Risk of uterine perforation during implantation | 31 March 2025
- Paracetamol (Pdf, 485 Kb): Reminder of proper use and risks associated with overdosing | 14 February 2025
- Medicines containing capecitabine (Pdf, 489 Kb): Caution in interpreting the results of screening for DPD deficiency by measuring uracil blood levels in patients with moderate renal impairment | 14 February 2025
- XTANDI® (enzalutamide) softgel capsules (Pdf, 288 Kb): Interference between enzalutamide and serum digoxin immunoassay by the CMIA method | 5 February 2025
- VEOZA™(fezolinetant) (Pdf, 233 Kb): Risk of drug-induced liver damage and new recommendations for monitoring liver function before and during treatment | 13 January 2025
2024
- Medicines containing metamizole (Pdf, 151 Kb): Important measures to minimise serious effects of known risk of agranulocytosis | 17 December 2024
- Pseudoephedrine-containing medicinal products (Pdf, 427 Kb): change in prescription status | 11 December 2024
- Ocaliva® (obeticholic acid) film-coated tablets (Pdf, 260 Kb): Revocation of marketing authorisation and withdrawal of a batch of Ocaliva | 11 December 2024
- Paracetamol (Pdf, 441 Kb): risk of serious cases of high anion gap metabolic acidosis (HAGMA) following treatment with paracetamol alone or in combination with flucloxacillin | 29 November 2024
- Finasteride and dutasteride (Pdf, 436 Kb): Risk of suicide and suicidal ideation after use of 5-alpha reductase inhibitors (5-ARIs): finasteride and potential risk for dutasteride. | 29 November 2024
- Medicines containing 5-fluorouracil (i.v.) (5FU) (Pdf, 282 Kb): In patients with moderate or severe renal impairment, screening for dihydropyrimidine dehydrogenase (DPD) deficiency by measuring blood uracil levels should be interpreted with caution | 24 October 2024
- Medroxyprogesterone acetate (Pdf, 355 Kb): Risk of meningioma and measures to minimise this risk | 15 October 2024
- Pregabalin (Pdf, 389 Kb): Reminder of risks and correct use | 5 September 2024
- Pegasys® (peginterferon alfa-2a) injectable solution (Pdf, 168 Kb): Recommendations following limited drug availability | 5 September 2024
- Depakine® 300 mg/5 ml (60 mg/ml) syrup (Pdf, 302 Kb): No longer marketed | September 2024
- Glatiramer acetate (Pdf, 344 Kb): Anaphylactic reactions are possible months or even years after the beginning of treatment | September 2024
- Rabipur (Rabies vaccine, inactivated) (Pdf, 121 Kb): Report on rubber particles after reconstitution - Recommendations to minimise the risk of particles | 22 August 2024
- Information update regarding Ozempic® (semaglutide) and Victoza® (liraglutide) (Pdf, 174 Kb): shortage of supply | August 2024
- Mysimba▼ (naltrexone/bupropion) prolonged-release tablet (Pdf, 985 Kb): Risk of serious cases following combined use of Mysimba and opioid-containing medicines |16 August 2024
- Ocaliva (obeticholic acid) (Pdf, 250 Kb): Recommended revocation of marketing authorisation in the European Union due to unconfirmed clinical benefit | 31 July 2024
- Abecma®▼, Breyanzi®▼, Carvykti®▼, Kymriah®▼, Tecartus®▼ and Yescarta®▼ (CAR-T cell therapies to treat CD19 or BCMA) (Pdf, 625 Kb): Risk of secondary malignancy of T-cell origin | 18 July 2024
- Ozempic® (semaglutide) injectable solution (Pdf, 205 Kb): Recommendations following limited product availability | 21 June 2024
- Combined hormonal contraceptives (CHC) - chlormadinone acetate/ethinylestradiol (Bellina, Bellissima, Helen) (Pdf, 878 Kb): Slightly elevated risk of venous thromboembolism in women using combined hormonal contraceptives containing chlormadinone acetate and ethinylestradiol | 14 June 2024
- Fastum® gel (ketoprofen) (Pdf, 77 Kb): Measures designed to minimise the risks associated with topical formulations of ketoprofen | 22 May 2024
- Paxlovid (nirmatrelvir; ritonavir) (Pdf, 177 Kb): Reminder of the potentially life-threatening and fatal drug interactions with certain immunosuppressants, particularly tacrolimus | 20 March 2024
- Etoposide injection (Pdf, 291 Kb): Increased risk of infusion-related hypersensitivity reactions when administered with an in-line filter | 19 March 2024
- Medicines containing valproate (Pdf, 177 Kb): New measures concerning the potential risk of neurodevelopmental disorders in children born to fathers treated with valproate in the 3 months prior to conception | 6 February 2024
- Pseudoephedrine (Pdf, 265 Kb): Risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) | 6 February 2024
2023
- Oral retinoids (acitretin and isotretinoin)▼ (Pdf, 762 Kb): Reminder of restrictions to prevent exposure during pregnancy | 27 December 2023
- LEQVIO® (inclisiran) 284 mg solution for injection in pre-filled syringe (Pdf, 454 Kb): Important information regarding instructions for use before injection | 15 December 2023
- Voxzogo® (vosoritide) (Pdf, 1.48 Mb): Change to syringe and needle leading to administration in units (U) instead of mL | 27 November 2023
- Ozempic® (semaglutide) and Victoza® (liraglutide) (Pdf, 299 Kb): Shortage of supply | 24 November 2023
- Integrilin (eptifibatide) (Pdf, 455 Kb): Production of Integrilin discontinued | 10 November 2023
- Ethyl esters of Omega-3 acids (Pdf, 196 Kb): Dose-dependent increased risk of atrial fibrillation in patients with cardiovascular disease or cardiovascular risk factors | 8 November 2023
- Topamax (topiramate) (Pdf, 162 Kb): New restrictions to prevent exposure during pregnancy | 30 October 2023
- Hemlibra (emicizumab) and MabThera (rituximab) (Pdf, 291 Kb): Leaflet potentially missing from external packaging | 18 August 2023
- Simponi (golimumab) 50 mg and 100 mg (Pdf, 358 Kb): Major changes to the instructions on how to use the SmartJect pre-filled pen | 8 August 2023
- Gavreto (pralsetinib) (Pdf, 278 Kb): Increased risk of tuberculosis and measures to minimise this risk | 16 June 2023
- Clomid (clomiphene citrate) (Pdf, 165 Kb): Visual disorders associated in some cases with reversible or permanent/irreversible, partial or total visual impairment (blindness) | 14 June 2023
- Adakveo® (crizanlizumab) (Pdf, 366 Kb): revocation of marketing authorisation in the European Union due to lack of therapeutic efficacy | 13 June 2023
- Antibiotics of the fluoroquinolone family administered systemically or by inhalation (Pdf, 632 Kb) - reminder of restrictions on use | 8 June 2023
- Colchicine Opocalcium® (colchicine) (Pdf, 233 Kb): Amendment to the ‘Dosage and administration’ section of the Summary of Product Characteristics (SPC) and the package leaflet for Colchicine Opocalcium 1 mg | 1 June 2023
- Fastum® gel (ketoprofen) (Pdf, 138 Kb): Measures designed to minimise the risks associated with topical formulations of ketoprofen | 15 May 2023
- Shortage of Fasturtec ® (rasburicase) (Pdf, 204 Kb): 7.5 mg/5 ml powder and solvent for concentrate for solution for infusion (EU/1/00/170/002) and Change of packaging of Fasturtec ® (rasburicase) 1.5 mg/1 ml powder and solvent for concentrate for solution for infusion (EU/1/00/170/001) | 14 April 2023
- Pholcodine (Pdf, 352 Kb): pholcodine-containing medicinal products no longer available on the European Union market | 3 April 2023
- Cibinqo (abrocitinib), Jyseleca (filgotinib), Olumiant (baricitinib), Rinvoq (upadacitinib) and Xeljanz (tofacitinib) (Pdf, 197 Kb): Updated recommendations to minimise the risks of malignancy, major adverse cardiovascular events, serious infections, venous thromboembolic disease and mortality associated with the use of Janus kinase inhibitors (JAKi) | 16 March 2023
- Zolgensma (onasemnogene abeparvovec) (Pdf, 437 Kb): Fatal cases of acute liver failure | 14 February 2023
- Adakveo (crizanlizumab) (Pdf, 434 Kb): Phase III study (CSEG101A2301) shows no superiority of crizanlizumab over placebo | 10 February 2023
2022
- Caprelsa® (vandétanib) (Pdf, 203 Kb): restriction of indication | 22.12.2022
- Xalkori (crizotinib) (Pdf, 81 Kb): Vision disorders, including risk of severe vision loss, monitoring needed in paediatric patients | 16 November 2022
- Chlormadinone acetate and nomegestrol acetate (Pdf, 233 Kb): Measures to minimise the risk of meningioma | 11 November 2022
- Ozempic® (semaglutide), solution for injection in pre-filled pen (Pdf, 299 Kb): tense supply situation | 9 November 2022
- Imbruvica (ibrutinib) (Pdf, 216 Kb): New risk-minimisation measures, including dose modification recommendations, due to the increased risk of serious cardiac events | 3 November 2022
- Pholcodine-containing medicinal products (Pdf, 546 Kb): Suspension of marketing authorisation and withdrawal of all boxes of pholcodine-containing syrup due to risk of cross-allergy with curares | 14 October 2022
- Metalyse® (tenecteplase) 10,000 units (50 mg), powder and solvent for solution for injection (Pdf, 271 Kb): Temporary supply shortage | 23 September 2022
- Safety information regarding pholcodine-containing medicines (Pdf, 657 Kb): Serious and potentially fatal risk of cross-allergy with curares, neuromuscular blocking agents (NMBA) | 13 September 2022
- (Pdf, 161 Kb)Rubraca® (rucaparib): (Pdf, 161 Kb) Restriction of indication | 12 August 2022
- Sabril® (vigabatrine): Temporary shortage of Sabril® 500 mg film-coated tablets | 27 July 2022
- Caprelsa® (vandetanib): (Pdf, 172 Kb) Shortage of Caprelsa® 100 mg film-coated tablets | 22 July 2022
- Cetrotide® (cetrorelix acetate) 0.25 mg powder and solvent for solution for injection: (Pdf, 224 Kb) Temporarily unavailable | 15.07.2022
- Ocaliva (obeticholic acid): (Pdf, 675 Kb) New contraindication for the treatment of primary biliary cholangitis (PBC) in patients with decompensated liver cirrhosis or a history of hepatic decompensation | 15 June 2022
- Defitelio® (defibrotide) (Pdf, 153 Kb): Do not use for prophylaxis of veno-occlusive disease (VOD) after hematopoietic stem-cell transplantation (HSCT) | 13 June 2022
- Dexmedetomidine-containing medicinal products - Dexdor® Dexmedetomidine Accord® (Pdf, 149 Kb): Increased risk of mortality in intensive care unit (ICU) patients aged ≤ 65 years | 16 June 2022
- Donepezil-containing medicinal products – Aricept® Donepezil EG® (Pdf, 373 Kb): New safety information in relation to cardiac conduction disorders, including torsades de pointes and QT prolongation | 12 May 2022
- Fastum® (ketoprofen) (Pdf, 95 Kb): Measures designed to minimise the risks associated with topical formulations of ketoprofen (Fastum gel) | 22 May 2022
- Rubraca® (rucaparib) (Pdf, 160 Kb): interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care | 10 May 2022
- Remicade®, Flixabi®, Inflectra®, Remsima®, Zessly® (infliximab) (Pdf, 1.73 Mb): Use of live vaccines in infants exposed to infliximab in utero or during breastfeeding | 7 March 2022
- Irinotecan hydrochloride (Pdf, 130 Kb) - Recommendations to consider lowering the initial dose to reduce the risk of irinotecan-induced neutropenia and diarrhoea in patients with UGT1A1 *28 and *6 variants | 24 February 2022
- Louise® (dienogest/ethinylestradiol) (Pdf, 305 Kb): Attention should be paid to the slightly increased risk of venous thromboembolism (VTE) in women using dienogest/ethinylestradiol-based CHCs compared with users of levonorgestrel/ethinylestradiol-based CHCs, for whom the risk is lower | 22 February 2022
- Anagrelide-containing medicinal products – Xagrid®, Atremia®, Anagrelid Sandoz® (Pdf, 128 Kb): Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation | 22 February 2022
- Mavenclad® (cladribine) (Pdf, 216 Kb): Risk of serious liver damage and new recommendations for monitoring liver function | 14 February 2022
2021
- Beovu® (brolucizumab) (Pdf, 342 Kb) 2 November 2021
- Forxiga® (dapagliflozine) (Pdf, 256 Kb) (29 October 2021)
- Lynparza® (olaparib) (Pdf, 392 Kb) (22 October 2021)
- Vaxzevria / COVID-19 Vaccine AstraZeneca (Pdf, 263 Kb) (13 October 2021)
- COVID-19 Vaccine Janssen (Pdf, 180 Kb) (13 October 2021)
- Dinoprostonen-containing medicinal products (Pdf, 789 Kb) (7 October 2021)
- Champix® (Varenicline) (Pdf, 101 Kb) (30 September 2021)
- RoActemra® (Tocilizumab) (Pdf, 129 Kb) (3 September 2021)
- Comirnaty® and Spikevax® mRNA vaccines against COVID-19 (Pdf, 241 Kb) (19 July 2021)
- COVID-19 Vaccine Janssen (Pdf, 205 Kb) (19 July 2021)
- Champix® (Varenicline) (Pdf, 106 Kb) (15 July 2021)
- Xeljanz® (tofacitinib) (Pdf, 385 Kb) (6 July 2021)
- Vaxzevria/COVID-19 Vaccine AstraZeneca® (Pdf, 260 Kb) (23 June 2021)
- Venclyxto® (venetoclax) (Pdf, 2.11 Mb) (10 June 2021)
- Vaxzevria/COVID-19 Vaccine AstraZeneca® (Pdf, 262 Kb) (2 June 2021)
- Valtran® (naloxone/tilidine) (Pdf, 266 Kb) (15 June 2021)
- COVID-19 Vaccine Janssen® (Pdf, 280 Kb) (26 April 2021)
- Fastum® (ketoprofen) (Pdf, 205 Kb) (26 May 2021)
- Vaxzevria/COVID-19 Vaccine AstraZeneca® (Pdf, 206 Kb) (13 April 2021)
- Eylea 40mg/ml® (aflibercept) (Pdf, 224 Kb) (15 April 2021)
- Vaxzevria/COVID-19 Vaccine AstraZeneca® (Pdf, 260 Kb) (24 March 2021)
- Xeljanz® (tofacitinib) (Pdf, 351 Kb) (23 March 2021)
- Tecentriq® (atezolizumab) (Pdf, 121 Kb) (22 March 2021)
- Zolgensma® (onasemnogene abeparvovec) (Pdf, 3.97 Mb) (18 March 2021)
- Stilnoct® (zolpidem) (Pdf, 140 Kb): Addition of new formats of Stilnoct 10 mg (7 and 28 film-coated tablets) and planned discontinuation of other formats | 2 April 2021
- Esmya® 5mg (ulipristal acetate) (Pdf, 186 Kb) (29 January 2021)
Last update