Rekovelle 72 µg/2.16 ml

Hauptinformation

  • Handelsname:
  • Rekovelle 72 µg/2.16 ml Injektionslösung
  • Darreichungsform:
  • Injektionslösung
  • Zusammensetzung:
  • follitropinum delta 72 µg, polysorbatum 20, natrii sulfas decahydricus, dinatrii phosphas dodecahydricus, conserv.: phenolum 10.8 mg, antiox.: methioninum 2.2 mg, aqua ad iniectabilia q.s. ad solutionem pro 1.08 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

  • für die Allgemeinheit:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie das Informationsblatt für die Öffentlichkeit.

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Rekovelle 72 µg/2.16 ml Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Biotechnologika
  • Therapiebereich:
  • Stimulierung der Follikelreifung bei ärztlich assistierten Reproduktionsprogrammen

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 66140
  • Berechtigungsdatum:
  • 24-11-2017
  • Letzte Änderung:
  • 02-02-2018

19-5-2018

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix

Century Snacks of Commerce, CA, is recalling certain 16 OZ. bags of Tropical Trail Mix because they may contain milk, soy, wheat and cashew allergens and this is not declared on the package. Individuals who have an allergy or severe sensitivity to milk, soy, wheat or cashews run the risk of serious or life-threatening allergic reaction if they consume these products

FDA - U.S. Food and Drug Administration

16-5-2018

Enforcement Report for the Week of May 16, 2018

Enforcement Report for the Week of May 16, 2018

FDA - U.S. Food and Drug Administration

21-5-2018

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Active substance: (manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-?N5, ?N13, ?N18, ?N21, ?N22]-)) - Transfer of orphan designation - Commission Decision (2018)3136 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/089/07/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1684 (Pharma Gateway AB)

EU/3/16/1684 (Pharma Gateway AB)

EU/3/16/1684 (Active substance: Modified mRNA encoding the UGT1A1 protein) - Transfer of orphan designation - Commission Decision (2018)3132 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/047/16/T/01

Europe -DG Health and Food Safety

16-5-2018

Busulfan Fresenius Kabi (Fresenius Kabi Deutschland GmbH)

Busulfan Fresenius Kabi (Fresenius Kabi Deutschland GmbH)

Busulfan Fresenius Kabi (Active substance: busulfan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3005 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2806/T/8

Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 1 (Merial)

BTVPUR AlSap 1 (Merial)

BTVPUR AlSap 1 (Active substance: Bluetongue Virus Serotype 1 antigen) - Centralised - Withdrawal - Commission Decision (2018)3017 of Wed, 16 May 2018

Europe -DG Health and Food Safety

16-5-2018

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3053 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2325/T/19

Europe -DG Health and Food Safety

16-5-2018

Tivicay (ViiV Healthcare BV)

Tivicay (ViiV Healthcare BV)

Tivicay (Active substance: dolutegravir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3052 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2753/T/39

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety

16-5-2018

Inflectra (Hospira UK Limited)

Inflectra (Hospira UK Limited)

Inflectra (Active substance: Infliximab) - Centralised - Yearly update - Commission Decision (2018)3054 of Wed, 16 May 2018

Europe -DG Health and Food Safety

16-5-2018

Alofisel (Takeda Pharma A/S)

Alofisel (Takeda Pharma A/S)

Alofisel (Active substance: Darvadstrocel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3050 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4258/T/1

Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 8 (Merial)

BTVPUR AlSap 8 (Merial)

BTVPUR AlSap 8 (Active substance: Bluetongue virus Serotype 8 Antigen) - Centralised - Withdrawal - Commission Decision (2018)3018 of Wed, 16 May 2018

Europe -DG Health and Food Safety

16-5-2018

EU/3/06/375 (Novartis Europharm Limited)

EU/3/06/375 (Novartis Europharm Limited)

EU/3/06/375 (Active substance: Nilotinib) - Transfer of orphan designation - Commission Decision (2018)3033 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/06/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/09/667 (Takeda Pharma A/S)

EU/3/09/667 (Takeda Pharma A/S)

EU/3/09/667 (Active substance: Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue) - Transfer of orphan designation - Commission Decision (2018)3029 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/054/09/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/13/1116 (GlaxoSmithKline Trading Services Limited)

EU/3/13/1116 (GlaxoSmithKline Trading Services Limited)

EU/3/13/1116 (Active substance: Mepolizumab) - Transfer of orphan designation - Commission Decision (2018)3046 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/174/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/04/213 (GlaxoSmithKline Trading Services Limited)

EU/3/04/213 (GlaxoSmithKline Trading Services Limited)

EU/3/04/213 (Active substance: Mepolizumab) - Transfer of orphan designation - Commission Decision (2018)3045 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/027/04/T/02

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1919 (Roche Registration GmbH)

EU/3/17/1919 (Roche Registration GmbH)

EU/3/17/1919 (Active substance: Bitopertin) - Transfer of orphan designation - Commission Decision (2018)3030 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/112/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1382 (Novartis Europharm Limited)

EU/3/14/1382 (Novartis Europharm Limited)

EU/3/14/1382 (Active substance: Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist) - Transfer of orphan designation - Commission Decision (2018)3044 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/120/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1345 (Novartis Europharm Limited)

EU/3/14/1345 (Novartis Europharm Limited)

EU/3/14/1345 (Active substance: Osilodrostat) - Transfer of orphan designation - Commission Decision (2018)3043 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/13/1205 (Novartis Europharm Limited)

EU/3/13/1205 (Novartis Europharm Limited)

EU/3/13/1205 (Active substance: Human monoclonal antibody against human interleukin 13) - Transfer of orphan designation - Commission Decision (2018)3042 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/118/13/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Active substance: Panobinostat) - Transfer of orphan designation - Commission Decision (2018)3041 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Active substance: Humanised monoclonal antibody against P-selectin) - Transfer of orphan designation - Commission Decision (2018)3040 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/12/T/02

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3039 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/016/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Active substance: Everolimus) - Transfer of orphan designation - Commission Decision (2018)3038 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/09/671 (Novartis Europharm Limited)

EU/3/09/671 (Novartis Europharm Limited)

EU/3/09/671 (Active substance: pasireotide) - Transfer of orphan designation - Commission Decision (2018)3037 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/052/09/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/09/670 (Novartis Europharm Limited)

EU/3/09/670 (Novartis Europharm Limited)

EU/3/09/670 (Active substance: pasireotide) - Transfer of orphan designation - Commission Decision (2018)3036 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/051/09/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Active substance: Recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/kappa class) - Transfer of orphan designation - Commission Decision (2018)3035 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/059/08/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/06/391 (Novartis Europharm Limited)

EU/3/06/391 (Novartis Europharm Limited)

EU/3/06/391 (Active substance: Amphotericin B (for inhalation use)) - Transfer of orphan designation - Commission Decision (2018)3034 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/027/06/T/03

Europe -DG Health and Food Safety

16-5-2018

EU/3/04/214 (Novartis Europharm Limited)

EU/3/04/214 (Novartis Europharm Limited)

EU/3/04/214 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3032 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/028/04/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/03/140 (Novartis Europharm Limited)

EU/3/03/140 (Novartis Europharm Limited)

EU/3/03/140 (Active substance: Tobramycin (inhalation powder)) - Transfer of orphan designation - Commission Decision (2018)3031 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/072/02/T/02

Europe -DG Health and Food Safety

16-5-2018

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Active substance: fluralaner / moxidectin) - Centralised - Authorisation - Commission Decision (2018)3019 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4440

Europe -DG Health and Food Safety

16-5-2018

Suvaxyn Aujeszky 783 + O/W (Zoetis Belgium S.A.)

Suvaxyn Aujeszky 783 + O/W (Zoetis Belgium S.A.)

Suvaxyn Aujeszky 783 + O/W (Active substance: Not available) - Centralised - Yearly update - Commission Decision (2018)3016 of Wed, 16 May 2018

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3026 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/16/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (Active substance: Rovalpituzumab tesirine) - Transfer of orphan designation - Commission Decision (2018)3025 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/015/16/T02

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3023 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/205/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

15-5-2018

Lynparza (AstraZeneca AB)

Lynparza (AstraZeneca AB)

Lynparza (Active substance: Olaparib) - Centralised - Variation - Commission Decision (2018)2987 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3726/X/16/G

Europe -DG Health and Food Safety

15-5-2018

Rekovelle (Ferring Pharmaceuticals A/S)

Rekovelle (Ferring Pharmaceuticals A/S)

Rekovelle (Active substance: follitropin delta) - Centralised - Yearly update - Commission Decision (2018)2998 of Tue, 15 May 2018

Europe -DG Health and Food Safety

3-5-2018

Wondering “What is enough?” when determining the participation of women in cardiovascular disease trials? We discuss this complex question during The Great Debate on 5/16 at 1 p.m. EST.  https://go.usa.gov/xQ9Xq  #NWHW #SABVpic.twitter.com/NP8ni58sA1

Wondering “What is enough?” when determining the participation of women in cardiovascular disease trials? We discuss this complex question during The Great Debate on 5/16 at 1 p.m. EST. https://go.usa.gov/xQ9Xq  #NWHW #SABVpic.twitter.com/NP8ni58sA1

Wondering “What is enough?” when determining the participation of women in cardiovascular disease trials? We discuss this complex question during The Great Debate on 5/16 at 1 p.m. EST. https://go.usa.gov/xQ9Xq  #NWHW #SABV pic.twitter.com/NP8ni58sA1

FDA - U.S. Food and Drug Administration

3-5-2018

Agenda:  CHMP ORGAM agenda for the meeting on 16 April 2018

Agenda: CHMP ORGAM agenda for the meeting on 16 April 2018

Europe - EMA - European Medicines Agency

2-5-2018

 Minutes of the CAT meeting 15-16 February 2018

Minutes of the CAT meeting 15-16 February 2018

Europe - EMA - European Medicines Agency

1-5-2018

01.05.2018: Dacogen, Lyophilisat zur Herstellung eines Konzentrats zur Herstellung einer Infusionslösung, Durchstechflasche(n), 1477.95, -5.2%

ODDB.org: Open Drug DatabaseSwissmedic-Nummer62406001 ZulassungsinhaberJanssen-Cilag AGNameDacogen, Lyophilisat zur Herstellung eines Konzentrats zur Herstellung einer InfusionslösungRegistrierungsdatum18.10.2012  Erstzulassung Sequenz18.10.2012ATC-KlassierungDecitabine (L01BC08)Revisionsdatum WHOWHO-DDDGültig bis18.10.2022Index Therapeuticus (BSV)07.16.10.PackungsgrösseDurchstechflasche(n)Index Therapeuticus (Swissmedic)07.16.10.Beschreibung AbgabekategorieA  SL Eintra...

ODDB -Open Drug Database

1-5-2018

01.05.2018: Perjeta 420 mg, Konzentrat zur Herstellung einer Infusionslösung, Durchstechflasche(n), 3304.10, -12.2%

ODDB.org: Open Drug DatabaseSwissmedic-Nummer62510001 PSZulassungsinhaberRoche Pharma (Schweiz) AGNamePerjeta 420 mg, Konzentrat zur Herstellung einer InfusionslösungRegistrierungsdatum13.08.2012  Erstzulassung Sequenz13.08.2012ATC-KlassierungPertuzumab (L01XC13)Revisionsdatum WHOWHO-DDDGültig bis12.08.2022Index Therapeuticus (BSV)07.16.10.PackungsgrösseDurchstechflasche(n)Index Therapeuticus (Swissmedic)07.16.10.Beschreibung AbgabekategorieA  SL EintragJaAnwendungMamma...

ODDB -Open Drug Database

30-4-2018

Lucentis (Novartis Europharm Limited)

Lucentis (Novartis Europharm Limited)

Lucentis (Active substance: ranibizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2710 of Mon, 30 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/715/t/72

Europe -DG Health and Food Safety