Danish translations of the PhVWP recommendations for the wording of product information

Updated 23 May 2016

The European Pharmacovigilance Working Party, PhVWP, has prepared a series of recommendations for the wording of summaries of product characteristics and package leaflets. Below is a list of the Danish Medicines Agency's Danish translations of the recommendations.

The texts are used to prepare new product information. Furthermore, the marketing authorisation holders must implement the texts by submitting variation applications (type IB (C.I.3)) for the relevant products in accordance with the CMDh's (Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human) application deadlines.

The list is updated on an ongoing basis with new translations. The Danish Medicines Agency urges marketing authorisation holders to use the texts as we make them available on the website.

Find the English recommendations on the CMDh website (see the link in the box to the right).

Danish translations of the PhVWP recommendations

Additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors (PDF file in Danish)

Antiepileptics and possible risk of bone disorder (PDF file in Danish)

Antiepileptics and suicidal behaviour (PDF file in Danish)

Antidepressants and suicidal thoughts and behaviour (PDF file in Danish)

Antipsychotics and risk of venous thromboembolism (VTE) (PDF file in Danish)

Antipsychotics (conventional and atypical): Use during pregnancy and risk of abnormal muscle movement and withdrawal symptoms in newborns (in Danish) (PDF file in Danish)

Association of HMG-CoA Reductase Inhibitors with safety concerns: sleep disturbances; memory loss; micturition disorders; sexual disturbance; depression; interstitial pneumopathy (PDF file in Danish)

Carbamazepine (PDF file)

Carbamazepine related Stevens Johnson Syndrome and association with HLA-B*1502 (PDF file in Danish)

Ceftriaxone and the risk of precipitation when given with calcium (PDF file in Danish)

Citalopram and risk of QT interval prolongation (PDF file in Danish)

Conventional (Typical) Antipsychotics and increased mortality in elderly people with dementia (PDF file in Danish)

Dopamine agonists, levodopa and COMT inhibitors (PDF file)

Donepezil (PDF file in Danish)

Escitalopram (PDF file)

Fluoxetine and the risk of Congenital Malformations (PDF file in Danish)

Fluoroquinolones and risk of QT-interval prolongation (PDF file in Danish)

Gabapentin and risk of drug rash with eosinophilia and systemic symptoms (PDF file in Danish)

Gonadotropin-releasing hormone agonists and depression (PDF file in Danish)

HMG-CoA reductase inhibitors (statins) (PDF file in Danish)

Hydrochlorothiazide (HCTZ) and use in lactation + consolidated wording for the SmPC and PL of ACE-inhibitors alone or in combination with HCTZ in pregnancy and lactation (PDF file in Danish)

Insulin products and risk of cardiac failure with concomitant use of pioglitazone (PDF file in Danish)

Isotretinoin and the risk of erythema multiforme (PDF file in Danish)

Ketroprofen and ketorolac (PDF in Danish only)

Ophthalmic beta-blockers (PDF file in Danish)

Oral methotrexate – assessment of potential fatal overdose due to medication error (PDF file in Danish)

Oxcarbazepine (Trileptal) (PDF file)

Paracetamol solution for infusion and risk of accidental overdosing of neonates, infants and underweight adults (PDF file in Danish)

Prescription-only proton pump inhibitors (omeprazole esomeprazole/naproxen, omeprazole/ketoprofen, esomeprazole, lansoprazole, pantoprazole, rabeprazole) and risk of fractures of the hip, wrist and spine (PDF file in Danish)

Proton-pump inhibitors' class effects on magnesium blood levels from long-term use (PDF file in Danish)

Risedronate and the risk of oesophageal cancer (PDF file in Danish)

Risk of allopurinol-induced serious cutaneous adverse reactions – association in patients who are carriers of the HLA-B*5801 allele (PDF file in Danish)

Risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drugs reactions to intranasal corticosteroids (PDF file in Danish)

Rosuvastatin and risk of gynaecomastia (PDF file in Danish)

SSRIs – fluvoxamine, citalopram, escitalopram, fluoxetine, sertraline and paroxetine (PDF file in Danish)

SSRIs and TCAs and the risk of bone fractures (PDF file in Danish)

SSRIs, venlafaxine and mirtazapine and the risk of Persistent Pulmonary Hypertension in Neonates (PPHN) (PDF file in Danish)

Stevens-Johnsons Syndrome and Toxic Epidermal Necrolysis for "high risk" drugs (PDF file in Danish)

Strattera (atomoxetine) (PDF file in Danish)

Tamoxifen and the risk of variability in clinical response due to CYP2D6 genetic variants or when given with CYP2D6 inhibitors (PDF file in Danish)

Tibolone (Livial) (PDF file)

Topiramate and risk of congenital malformations (PDF file in Danish)

Tramadol and risk of convulsion, serotonin syndrome, suicide and posology in the elderly and in patients with renal or hepatic impairment (PDF) (PDF file in Danish)

Valproic Acid and the risk of interaction with carbapenems (PDF file in Danish)