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Medicine
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Direct healthcare professional communication (DHPC): Cetrorelix acetate - Cetrotide 0.25 mg Powder and solvent for injection: Temporary Shortage (updated)
Active substance: cetrorelix (as acetate), DHPC type: Medicine shortage, Last updated: 09/08/2022 -
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Opinion on medicine for use outside EU: Mosquirix (updated)
RTS,S [Portion of P. falciparum circumsporozoite protein fused with hepatitis B surface antigen (RTS), and combined with hepatitis B surface antigen (S)], , ATC code: J07 Opinion number: H-W-2300, Positive opinion Opinion date: 23/07/2015, Last updated: 01/08/2022 -
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Opinion on medicine for use outside EU: Fexinidazole Winthrop (updated)
fexinidazole, Trypanosomiasis, African, ATC code: P01CA03 Opinion number: H-W-2320, Positive opinion Opinion date: 15/11/2018, Last updated: 01/08/2022 -
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Opinion on medicine for use outside EU: Insulatard (updated)
Insulin human (RDNA), Diabetes Mellitus, ATC code: A10AC01 Opinion number: H-W-005780, Positive opinion Opinion date: 22/04/2022, Last updated: 28/07/2022 -
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Direct healthcare professional communication (DHPC): Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm (updated)
Active substance: hydroxyethyl starch, DHPC type: Post-authorisation measure, Last updated: 26/07/2022 -
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Opinion on medicine for use outside EU: Actrapid (updated)
insulin human, Diabetes Mellitus, ATC code: A10AC01 Opinion number: H-W-005779, Positive opinion Opinion date: 22/04/2022, Last updated: 22/07/2022 -
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Opinion on medicine for use outside EU: Dapivirine Vaginal Ring 25 mg (updated)
dapivirine, Anti-HIV Agents, ATC code: G01AX17 Opinion number: H-W-2168, Positive opinion Opinion date: 23/07/2020, Last updated: 20/07/2022 -
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Opinion on medicine for use outside EU: Pyramax
artesunate, pyronaridine, Malaria, ATC code: P01BF06 Opinion number: H-W-2319, Positive opinion Opinion date: 16/02/2012, Last updated: 16/06/2022 -
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Opinion on medicine for use outside EU: Umbipro
chlorhexidine digluconate, Soft Tissue Infections, ATC code: D08AC02 Opinion number: H-W-3799, Withdrawn opinion Opinion date: 28/04/2016, Last updated: 08/04/2022 -
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Direct healthcare professional communication (DHPC): CHAMPIX (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the acceptable intake limit
Active substance: varenicline, DHPC type: Medicine shortage, Last updated: 30/09/2021 -
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Direct healthcare professional communication (DHPC): Tecentriq (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)
Active substance: atezolizumab, DHPC type: Adverse event, Last updated: 25/03/2021 -
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Direct healthcare professional communication (DHPC): Brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine
Active substance: Brivudine, DHPC type: Periodic safety update single assessment, Last updated: 12/05/2020 -
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Direct healthcare professional communication (DHPC): Metamizole: Risk of drug-induced liver injury
Active substance: metamizole, DHPC type: Periodic safety update report, Last updated: 15/12/2020 -
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Opinion on medicine for use outside EU: Globorix
Diphtheria toxoid, Tetanus toxoid, Bordetella pertussis (inactivated), Haemophilus influenzae type b polysaccharide, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, hepatitis B surface antigen, Immunization; Hepatitis B; Diphtheria-Tetanus-Pertussis Vaccine; Bordetella pertussis; Haemophilus influenzae type b; Neisseria meningitidis, Serogroup A; Neisseria meningitidis, Serogroup C, ATC code: J07CA09 Opinion number: H/W/848, Withdrawn application , Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Lamivudine / Zidovudine ViiV (previously Lamivudine / Zidovudine GSK)
lamivudine, zidovudine, HIV Infections, ATC code: J05AR01 Opinion number: H/W/672, Withdrawn opinion Opinion date: 17/11/2005, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Lamivudine ViiV
lamivudine, HIV Infections, ATC code: J05AF05 Opinion number: H/W/673, Withdrawn opinion Opinion date: 17/11/2005, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Tritanrix HB
Bordetella pertussis (inactivated), Diphtheria toxoid, hepatitis B surface antigen, tetanus toxoid, Hepatitis; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, ATC code: J07CA05 Opinion number: H-W-3838, Withdrawn opinion Opinion date: 19/12/2013, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Hemoprostol
misoprostol, Postpartum Hemorrhage, ATC code: G02AD06 Opinion number: H-W-2652, Withdrawn opinion Opinion date: 23/01/2014, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Aluvia
lopinavir, ritonavir, HIV Infections, ATC code: J05AR10 Opinion number: H-W-764, Positive opinion Opinion date: 21/09/2006, Last updated: 20/08/2020 -
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Opinion on medicine for use outside EU: Hexaxim
Diphtheria toxoid, Tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain), hepatitis B surface antigen, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, ATC code: J07CA09 Opinion number: H-W-2495, Withdrawn opinion Opinion date: 21/06/2012, Last updated: 06/07/2018 -
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Direct healthcare professional communication (DHPC): Restrictions in use of cyproterone acetate due to risk of meningioma
Active substance: cyproterone, DHPC type: Referral - Article 31, Last updated: 29/04/2020 -
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Direct healthcare professional communication (DHPC): Flucytosine: Updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency
Active substance: Flucytosine, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
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Direct healthcare professional communication (DHPC): Leuprorelin-containing depot products: need to strictly follow instructions for reconstitution and administration to reduce the risk of handling errors that may result in lack of efficacy
Active substance: leuprorelin, DHPC type: Referral - Article 31, Last updated: 02/10/2020 -
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Direct healthcare professional communication (DHPC): Risks associated with systemic exposure to estradiol creams
Active substance: estradiol, DHPC type: Referral - Article 31, Last updated: 20/02/2020 -
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Direct healthcare professional communication (DHPC): Mepact 4mg (mifamurtide): Potential for filter leakage or malfunction
Active substance: mifamurtide, DHPC type: Quality defect, Last updated: 25/02/2020