United States - English - NLM (National Library of Medicine)

u.s. pharmaceuticals - dacomitinib (unii: 5092u85g58) (dacomitinib anhydrous - unii:2xjx250c20) - vizimpro is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 19 deletion or exon 21 l858r substitution mutations as detected by an fda-approved test [see dosage and administration (2.1)] . none. risk summary based on findings from animal studies and its mechanism of action, vizimpro can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on vizimpro use in pregnant women. in animal reproduction studies, oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss and reduced fetal body weight at doses resulting in exposures near the exposure at the 45 mg human dose (see data) . the absence of egfr signaling has been shown to result in embryolethality as well as post-natal death in animals (see data) . advise pregnant women of the potential risk to a fetus

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - dacomitinib monohydrate - carcinoma, non-small-cell lung - antineoplastic agents - vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) activating mutations.

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - dacomitinib monohydrate eqv dacomitinib - tablet, film coated - dacomitinib monohydrate eqv dacomitinib 15 mg

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - dacomitinib monohydrate eqv dacomitinib - tablet, film coated - dacomitinib monohydrate eqv dacomitinib 30 mg

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - dacomitinib monohydrate eqv dacomitinib - tablet, film coated - dacomitinib monohydrate eqv dacomitinib 45 mg

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - dacomitinib as monohydrate - film coated tablets - dacomitinib as monohydrate 15 mg - dacomitinib - vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) activating mutations.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - dacomitinib as monohydrate - film coated tablets - dacomitinib as monohydrate 30 mg - dacomitinib - vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) activating mutations.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - dacomitinib as monohydrate - film coated tablets - dacomitinib as monohydrate 45 mg - dacomitinib - vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) activating mutations.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pfizer (malaysia) sdn. bhd. - dacominitib monohydrate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pfizer (malaysia) sdn. bhd. - dacominitib monohydrate -