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366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 <a href="https://www.pharmnet-bund.de/PharmNet/EN/Public/_node.html" class="virgin c-nav-primary__link js-simple-toggle-opener" 397 398 > 399 Public 400 </a> 401 402 403 404 405 406<div class="c-nav-overlay js-simple-toggle-item"> 407 <div class="c-nav-overlay__row row"> 408 <div class="column small-12"> 409 410 <button class="c-nav-overlay__close js-simple-toggle-button" aria-label="Close"> 411 Close<svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 20 20"> 412 <path fill="#303030" 413 d="M13.118 10l6.236 6.236a2.2 2.2 0 0 1-3.118 3.118L10 13.118l-6.236 6.236a2.2 2.2 0 0 1-3.118-3.118L6.882 10 .646 3.764A2.2 2.2 0 0 1 3.764.646L10 6.882 16.236.646a2.2 2.2 0 0 1 3.118 3.118z"/> 414</svg></button> 415 416 <div class="c-nav-overlay__heading"> 417 418 <a class="c-nav-overlay__heading-link js-simple-toggle-link" 419 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</g> 426 </g> 427</svg></a> 428 </div> 429 430 431 432<div class="row"> 433 <ul class="c-nav-overlay__list column small-12 large-4"> 434 <li class="c-nav-overlay__item "> 435 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Advice/_node.html" 436 437> 438 Advice</a> 439 440 441 </li> 442 </ul> 443 <ul class="c-nav-overlay__list column small-12 large-4"> 444 <li class="c-nav-overlay__item "> 445 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Public/Drug-information-system/_node.html" 446 447> 448 Drug information system</a> 449 450 451 </li> 452 </ul> 453 <ul class="c-nav-overlay__list column small-12 large-4"> 454 <li class="c-nav-overlay__item "> 455 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Public/Clinical-trials/_node.html" 456 457> 458 Clinical trials</a> 459 460 461 </li> 462 </ul> 463 <ul class="c-nav-overlay__list column small-12 large-4"> 464 <li class="c-nav-overlay__item "> 465 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Public/Non-interventional-studies/_node.html" 466 467> 468 Non-interventional studies</a> 469 470 471 </li> 472 </ul> 473 <ul class="c-nav-overlay__list column small-12 large-4"> 474 <li class="c-nav-overlay__item "> 475 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Public/Pharmaceutical-brokers/_node.html" 476 477> 478 Pharmaceutical brokers</a> 479 480 481 </li> 482 </ul> 483 <ul class="c-nav-overlay__list column small-12 large-4"> 484 <li class="c-nav-overlay__item "> 485 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Public/Pharmaceutical-wholesaler/_node.html" 486 487> 488 Pharmaceutical wholesaler</a> 489 490 491 </li> 492 </ul> 493</div></div> 494 </div> 495 </div> 496 </div> 497 </li> 498 <li class="c-nav-primary__item js-nav-primary-toggle"> 499 <div class="" id="n-2"> 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 <a href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/_node.html" class="inpath c-nav-primary__link js-simple-toggle-opener" 546 547 aria-current="true" 548 549 > 550 Companies 551 </a> 552 553 554 555 556 557<div class="c-nav-overlay js-simple-toggle-item"> 558 <div class="c-nav-overlay__row row"> 559 <div class="column small-12"> 560 561 <button class="c-nav-overlay__close js-simple-toggle-button" aria-label="Close"> 562 Close<svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 20 20"> 563 <path fill="#303030" 564 d="M13.118 10l6.236 6.236a2.2 2.2 0 0 1-3.118 3.118L10 13.118l-6.236 6.236a2.2 2.2 0 0 1-3.118-3.118L6.882 10 .646 3.764A2.2 2.2 0 0 1 3.764.646L10 6.882 16.236.646a2.2 2.2 0 0 1 3.118 3.118z"/> 565</svg></button> 566 567 <div class="c-nav-overlay__heading"> 568 569 <a class="inpath c-nav-overlay__heading-link js-simple-toggle-link" 570 href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/_node.html"> 571 Companies in overview<svg width="26" height="17" viewBox="0 0 15 12" version="1.1" xmlns="http://www.w3.org/2000/svg"> 572 <g stroke="none" stroke-width="1" fill="none" fill-rule="evenodd"> 573 <g transform="translate(-976.000000, -301.000000)" fill="#007367"> 574 <path 575 d="M984.292893,301.292893 C984.683418,300.902369 985.316582,300.902369 985.707107,301.292893 L985.707107,301.292893 L990.707107,306.292893 C991.097631,306.683418 991.097631,307.316582 990.707107,307.707107 L990.707107,307.707107 L985.707107,312.707107 C985.316582,313.097631 984.683418,313.097631 984.292893,312.707107 C983.902369,312.316582 983.902369,311.683418 984.292893,311.292893 L984.292893,311.292893 L987.585,308 L977,308 C976.487164,308 976.064493,307.61396 976.006728,307.116621 L976,307 C976,306.447715 976.447715,306 977,306 L977,306 L987.585,306 L984.292893,302.707107 C983.932409,302.346623 983.90468,301.779392 984.209705,301.387101 Z"/> 576 </g> 577 </g> 578</svg></a> 579 </div> 580 581 582 583<div class="row"> 584 <ul class="c-nav-overlay__list column small-12 large-4"> 585 <li class="c-nav-overlay__item "> 586 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Active-substance-manufacturer/_node.html" 587 588> 589 Active substance manufacturer</a> 590 591 592 </li> 593 </ul> 594 <ul class="c-nav-overlay__list column small-12 large-4"> 595 <li class="c-nav-overlay__item "> 596 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Advice/_node.html" 597 598> 599 Advice</a> 600 601 602 </li> 603 </ul> 604 <ul class="c-nav-overlay__list column small-12 large-4"> 605 <li class="c-nav-overlay__item "> 606 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Approval-exempt/_node.html" 607 608> 609 Approval exempt</a> 610 611 612 </li> 613 </ul> 614 <ul class="c-nav-overlay__list column small-12 large-4"> 615 <li class="c-nav-overlay__item "> 616 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Batch-release/_node.html" 617 618> 619 Batch release</a> 620 621 622 </li> 623 </ul> 624 <ul class="c-nav-overlay__list column small-12 large-4"> 625 <li class="c-nav-overlay__item "> 626 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Digital-mailbox/_node.html" 627 628> 629 Digital mailbox</a> 630 631 632 </li> 633 </ul> 634 <ul class="c-nav-overlay__list column small-12 large-4"> 635 <li class="c-nav-overlay__item "> 636 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/ENR-and-EUV-allocation/_node.html" 637 638> 639 ENR and EUV Allocation</a> 640 641 642 </li> 643 </ul> 644 <ul class="c-nav-overlay__list column small-12 large-4"> 645 <li class="c-nav-overlay__item "> 646 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Graduated-plan-officer/_node.html" 647 648> 649 Graduated plan officer</a> 650 651 652 </li> 653 </ul> 654 <ul class="c-nav-overlay__list column small-12 large-4"> 655 <li class="c-nav-overlay__item "> 656 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Non-submission-renewals/_node.html" 657 658> 659 Non-submission renewals</a> 660 661 662 </li> 663 </ul> 664 <ul class="c-nav-overlay__list column small-12 large-4"> 665 <li class="c-nav-overlay__item "> 666 <a class="c-nav-overlay__link c-nav-overlay__link--int c-nav-overlay__link--active" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Product-information-texts/_node.html" 667 668 aria-current="page" 669 670> 671 Product information texts</a> 672 673 674 </li> 675 </ul> 676 <ul class="c-nav-overlay__list column small-12 large-4"> 677 <li class="c-nav-overlay__item "> 678 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Renouncements/_node.html" 679 680> 681 Renouncements</a> 682 683 684 </li> 685 </ul> 686 <ul class="c-nav-overlay__list column small-12 large-4"> 687 <li class="c-nav-overlay__item "> 688 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Results-clinical-trials/_node.html" 689 690> 691 Result reports of clinical trials</a
691> 692 693 694 </li> 695 </ul> 696 <ul class="c-nav-overlay__list column small-12 large-4"> 697 <li class="c-nav-overlay__item "> 698 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Sunset-clause/_node.html" 699 700> 701 Sunset Clause</a> 702 703 704 </li> 705 </ul> 706 <ul class="c-nav-overlay__list column small-12 large-4"> 707 <li class="c-nav-overlay__item "> 708 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Supergrouping/_node.html" 709 710> 711 Super-grouping</a> 712 713 714 </li> 715 </ul> 716 <ul class="c-nav-overlay__list column small-12 large-4"> 717 <li class="c-nav-overlay__item "> 718 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Supply-shortages/_node.html" 719 720> 721 Supply shortages</a> 722 723 724 </li> 725 </ul> 726 <ul class="c-nav-overlay__list column small-12 large-4"> 727 <li class="c-nav-overlay__item "> 728 <a class="c-nav-overlay__link c-nav-overlay__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Variation-submission/_node.html" 729 730> 731 Variation submission</a> 732 733 734 </li> 735 </ul> 736</div></div> 737 </div> 738 </div> 739 </div> 740 </li> 741 <li class="c-nav-primary__item "> 742 <div class="" id="n-3"> 743 744 745 746 747 748 749 750 751 752 753 754 755 756 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 781 782 783 784 785 786 787 788 <a href="https://www.pharmnet-bund.de/PharmNet/EN/National-authorities/_node.html" class="virgin c-nav-primary__link js-simple-toggle-opener" 789 790 > 791 National authorities 792 </a> 793 794 795 796 797 798</div> 799 </li> 800 <li class="c-nav-primary__item js-nav-primary-toggle"> 801 <div class="mod" id="n-4"> 802 803 804 805 806 807 808 809 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 827 828 829 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1296Deutsch</a> 1297 1298 1299 1300 1301</li> 1302 <li id="nn-1747642" class="service js-mobile-nav__node c-mobile-nav__item c-mobile-nav__item--meta c-mobile-nav__item--level1 is-closed Tree"> 1303 1304 1305 1306 1307 1308 1309 1310 1311 1312 1313 1314 1315 1316 1317 1318 1319 1320 1321 1322 1323 1324 1325 1326 1327 1328 1329 1330 1331 1332 1333 1334 1335 1336 1337 1338 1339 1340 1341 1342 1343 1344 1345 1346 1347 1348 1349 <a href="https://www.pharmnet-bund.de/PharmNet/EN/Service-navi/Contact/Seite_1/kontakt_node.html" class="c-mobile-nav__link" 1350 1351 > 1352 Contact 1353 </a> 1354 1355 1356 1357 1358 1359</li> 1360 <li id="nn-1747642" class="service js-mobile-nav__node c-mobile-nav__item c-mobile-nav__item--meta c-mobile-nav__item--level1 is-closed navServiceLogin"> 1361 <a class="c-mobile-nav__link c-mobile-nav__link--external c-mobile-nav__link--int" 1362 href="https://auth.bfarm.de/" 1363 title="External link PharmNet Login (Opens new window)" 1364 target="_blank" 1365 rel="noopener noreferrer"> 1366 1367 meinPharmNet</a> 1368 1369</li> 1370 </ul> 1371</nav> 1372 1373 1374 </div> 1375 </div> 1376 </div> 1377 </header> 1378 <main class="main row"> 1379 <div class="content small-12 medium-12 large-7 large-offset-3 column"> 1380 <div class="l-intro s-intro"> 1381 <div class="l-intro__wrapper l-intro__wrapper--unternehmen"> 1382 1383 <nav class="c-breadcrumbs js-breadcrumbs" role="navigation" aria-labelledby="breadcrumbMenu"> 1384 <h2 class="aural" id="breadcrumbMenu">You are here:</h2> 1385 <ol class="c-breadcrumbs__list js-breadcrumbs__list"> 1386 1387 <li class="c-breadcrumbs__item"> 1388 1389 <a class="c-breadcrumbs__link" href="https://www.pharmnet-bund.de/PharmNet/EN/Home/_node.html" title="Home" > 1390 <svg xmlns="http://www.w3.org/2000/svg" width="16.75" height="16.75" viewBox="0 0 16.75 16.75"> 1391 <path fill="none" stroke="#303030" stroke-linecap="round" stroke-linejoin="round" stroke-miterlimit="10" stroke-width="1.75" 1392 d="M15.875 8.375l-7.5-7.5-7.5 7.5h1.5v7.5h4.5v-6h3v6h4.5v-7.5z"/> 1393</svg></a> 1394 </li> 1395 1396 <li class="c-breadcrumbs__item"> 1397 1398 <a class="c-breadcrumbs__link c-breadcrumbs__link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/_node.html" 1399 title="Companies" 1400 aria-current="true" 1401 1402> 1403 Companies</a> 1404 1405</li> 1406 1407 <li class="c-breadcrumbs__item"> 1408 1409 <a class="c-breadcrumbs__link c-breadcrumbs__link--int c-breadcrumbs__link--active" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Product-information-texts/_node.html" 1410 title="Product information texts" 1411 aria-current="page" 1412 1413> 1414 Product information texts</a> 1415 1416</li> 1417 1418 </ol> 1419</nav> 1420 1421<div class="c-intro-content"> 1422 1423 <h1 class="c-intro-content__headline"> 1424 Product information texts</h1> 1425 </div> 1426 </div> 1427</div> 1428 1429<div class="l-contentwrapper" data-toc-level="0" data-open-index="0"> 1430 <p>Pursuant to Sections 11 sub-section 1a, 11a sub-section 3 of the Medicinal Products Act (<abbr title="Arzneimittelgesetz">AMG</abbr>), the submission of the current product information texts (Summary of Product Characteristics (<abbr title="Summary of Product Characteristics">SmPC</abbr>) and Package Leaflet (<abbr title="Patient Information Leaflet">PIL</abbr>) is required. These current text versions are made available to the public in electronic form in accordance with Section 34 <abbr title="Arzneimittelgesetz">AMG</abbr>. The texts have to be submitted via the application "Product information texts" (<abbr title="Produktinformationstexte">PIT</abbr>). These texts are the last approved text version of the instructions for use and expert information after the positive completion of the last text-relevant regulatory activity.</p> 1431 1432<p>In addition to the mandatory German-language versions, there is also the option to upload the associated confirmed English text versions.</p> 1433 1434<p>The "Product information texts" application replaces the previous submission process by email using the so-called "<abbr title="Arzneimittelgesetz">AMG</abbr> <abbr title="Einreichungsverordnung">EV</abbr> process".</p> 1435 1436<p><div class="l-content-wrapper l-content-wrapper--most-space-before"> 1437 <div class="row"> 1438 <div class="column"> 1439
1440 <div class="c-teaser-warnhinweis c-teaser-warnhinweis--pharmnet"> 1441 <div class="c-teaser-warnhinweis__wrapper"> 1442 1443 <h3 class="c-teaser-warnhinweis__headline"> 1444 Important notice</h3> 1445 1446 <p class="c-topline"> 1447 <span class="c-topline__date">2026.02.20</span> 1448 </p> 1449 <div class="c-teaser-warnhinweis__text"> 1450 <p>Due to a <strong>malfunction in the maintenance portal PIT - Product Information Texts</strong>, there are currently an increasing number of requests to marketing authorisation holders to upload older text versions. Please do <strong>not </strong>comply with these requests if they concern outdated text versions that have already been uploaded in the past. Also not in cases where standardised reminder emails are sent for supposedly open submissions. Only current versions of the product information texts are relevant for publication. The <abbr title="Bundesinstitut für Arzneimittel und Medizinprodukte">BfArM</abbr> is working intensively on correcting the errors. Thank you for your understanding.</p> 1451</div> 1452 1453 </div> 1454 1455 </div> 1456 1457 </div> 1458 </div> 1459</div></p> 1460<div class="l-content-wrapper l-content-wrapper--more-space-after"> 1461 <div class="row"> 1462 <div class="column"> 1463 <div class="c-teaser-mit-linkliste c-teaser-mit-linkliste--pharmnet"> 1464 <div class="c-teaser-mit-linkliste__wrapper"> 1465 <span class="c-teaser-mit-linkliste__topline" aria-hidden="true">login</span> 1466 <h3 class="c-teaser-mit-linkliste__headline">Product information texts</h3> 1467 <p>Application for submission of final product information texts</p> 1468 1469 1470 <p><a class="c-button c-button--pharmnet c-button--external c-button c-button--pharmnet c-button--external--external c-button c-button--pharmnet c-button--external--int" href="https://auth.bfarm.de/sso-home/maintpit" title="External link Produktinformationstexte (Opens new window)" target="_blank" rel="noopener noreferrer"> 1471 1472 Product information texts</a> 1473 1474</p> 1475 1476 <p>No access data available? <br/> 1477For information and manuals, see the service area:<br/> 1478<a class="RichTextIntLink NavNode" href="https://www.pharmnet-bund.de/PharmNet/EN/Service/User-authorisation/_node.html" title="Access and user authorisation">Request access authorisation and user administration</a></p> 1479 1480 </div> 1481 </div> 1482 </div> 1483 </div> 1484</div><div class="l-content-wrapper l-content-wrapper--most-space-before l-content-wrapper--most-space-after"> 1485 <div class="row"> 1486 <div class="column"> 1487 <h2 class="c-headline c-headline--h2">Supporting information</h2> 1488 <div class="c-teaser-mit-linkliste"> 1489 <ul class="c-teaser-mit-linkliste__list"> 1490 <li class="c-teaser-mit-linkliste__item"> 1491 <a class="c-link c-link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Service/Manuals/short-manual-pit.html?nn=1430154"> 1492 Short Manual for the application Product Information Texts (<abbr title="Produktinformationstexte">PIT</abbr>)</a> 1493</li> 1494 1495 1496 1497 <li class="c-teaser-mit-linkliste__item"> 1498 <a class="c-link c-link--int" href="https://www.pharmnet-bund.de/PharmNet/EN/Service/Manuals/terms-and-conditions-pit.html?nn=1430154"> 1499 Terms and conditions for the application Product Information Texts (<abbr title="Produktinformationstexte">PIT</abbr>)</a> 1500</li> 1501 1502 1503 1504 </ul> 1505 </div> 1506 </div> 1507</div> 1508</div></div> 1509<div class="sectionRelated"> 1510 </div> 1511 1512 <p class="l-sticky-nav"> 1513 <a href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Product-information-texts/_node.html#Start" title="to the top" class="c-nav-to-top js-navtotop" aria-label="to the top"> 1514 <svg xmlns="http://www.w3.org/2000/svg" width="47" height="52" viewBox="0 0 47 52"> 1515 <g transform="translate(0 52) rotate(-90)"> 1516 <g transform="translate(2 2)"> 1517 <path 1518 d="M33.711,43a4.562,4.562,0,0,0,3.96-2.3l9.72-16.9a4.642,4.642,0,0,0,0-4.6L37.671,2.3A4.562,4.562,0,0,0,33.711,0H14.289a4.562,4.562,0,0,0-3.96,2.3L.609,19.2a4.643,4.643,0,0,0,0,4.6l9.72,16.9a4.562,4.562,0,0,0,3.96,2.3Zm-6.72-14.893a1.318,1.318,0,0,1-1.588-.191h0L20.354,22.4a.787.787,0,0,1,0-1.1h0L25.4,15.787a1.32,1.32,0,0,1,1.588-.191.812.812,0,0,1,.24,1.286h0l-4.551,4.97,4.551,4.969A.812.812,0,0,1,26.991,28.107Z" 1519 transform="translate(48 43) rotate(180)" fill="#cfe3e0" fill-rule="evenodd"/> 1520 </g> 1521 <g transform="translate(20 15)" fill="#007367" class="chevron"> 1522 <path d="M 10.5 15.5 L 0.5 15.5 L 0.5 0.5 L 10.5 0.5 L 10.5 15.5 Z" stroke="none"/> 1523 <path d="M 1 1 L 1 15 L 10 15 L 10 1 L 1 1 M 0 0 L 11 0 L 11 16 L 0 16 L 0 0 Z" stroke="none" fill="#007367"/> 1524 </g> 1525 <g transform="translate(-1037 -229)"> 1526 <path class="border" 1527 d="M1073.52-229a4.935,4.935,0,0,0,4.29-2.513l10.53-18.474a5.114,5.114,0,0,0,0-5.026l-10.53-18.474a4.935,4.935,0,0,0-4.29-2.513h-21.04a4.935,4.935,0,0,0-4.29,2.513l-10.53,18.474a5.114,5.114,0,0,0,0,5.026l10.53,18.474a4.935,4.935,0,0,0,4.29,2.513Zm-7.28-16.278a1.419,1.419,0,0,1-1.72-.209h0l-5.47-6.03a.866.866,0,0,1,0-1.2h0l5.47-6.03a1.42,1.42,0,0,1,1.72-.209.892.892,0,0,1,.26,1.406h0l-4.93,5.432,4.93,5.431A.892.892,0,0,1,1066.24-245.278Z" 1528 transform="translate(2126) rotate(180)" fill="#007367" fill-rule="evenodd"/> 1529 </g> 1530 <g transform="translate(2 2)"> 1531 <path class="background" 1532 d="M33.711,43a4.562,4.562,0,0,0,3.96-2.3l9.72-16.9a4.642,4.642,0,0,0,0-4.6L37.671,2.3A4.562,4.562,0,0,0,33.711,0H14.289a4.562,4.562,0,0,0-3.96,2.3L.609,19.2a4.643,4.643,0,0,0,0,4.6l9.72,16.9a4.562,4.562,0,0,0,3.96,2.3Zm-6.72-14.893a1.318,1.318,0,0,1-1.588-.191h0L20.354,22.4a.787.787,0,0,1,0-1.1h0L25.4,15.787a1.32,1.32,0,0,1,1.588-.191.812.812,0,0,1,.24,1.286h0l-4.551,4.97,4.551,4.969A.812.812,0,0,1,26.991,28.107Z" 1533 transform="translate(48 43) rotate(180)" fill="#cfe3e0" fill-rule="evenodd"/> 1534 </g> 1535 </g> 1536</svg> 1537</a> 1538 </p> 1539 1540 </div> 1541 <div class="todo small-12 column"> 1542 1543 </div> 1544</main> 1545<div class="row"> 1546 <div class="small-12 medium-12 large-7 large-offset-3 column"> 1547 <div class="l-content-wrapper l-content-wrapper--bg-jade-ds l-content-wrapper--offset-ds"> 1548 <nav class="l-card-grid" role="navigation" aria-labelledby="sectionnavigation"> 1549 1550 <div class="row"> 1551 <div class="column"> 1552 <h1 class="l-card-grid__heading h3" id="sectionNavigation" role="none"> 1553 All topics at a glance</h1> 1554 </div> 1555 </div> 1556 <div class="row" role="list"> 1557 <div class="column small-12 medium-6 large-3" role="listitem"> 1558 <div class="l-card-grid__wrapper"> 1559 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Variation-submission/_node.html">
1560 <span class="c-card-link__heading h2"> 1561 Variation submission</span> 1562 </a> 1563 </div> 1564 </div> 1565 <div class="column small-12 medium-6 large-3" role="listitem"> 1566 <div class="l-card-grid__wrapper"> 1567 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Advice/_node.html"> 1568 <span class="c-card-link__heading h2"> 1569 Advice</span> 1570 </a> 1571 </div> 1572 </div> 1573 <div class="column small-12 medium-6 large-3" role="listitem"> 1574 <div class="l-card-grid__wrapper"> 1575 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Approval-exempt/_node.html"> 1576 <span class="c-card-link__heading h2"> 1577 Approval exempt</span> 1578 </a> 1579 </div> 1580 </div> 1581 <div class="column small-12 medium-6 large-3" role="listitem"> 1582 <div class="l-card-grid__wrapper"> 1583 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Batch-release/_node.html"> 1584 <span class="c-card-link__heading h2"> 1585 Batch release</span> 1586 </a> 1587 </div> 1588 </div> 1589 <div class="column small-12 medium-6 large-3" role="listitem"> 1590 <div class="l-card-grid__wrapper"> 1591 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Digital-mailbox/_node.html"> 1592 <span class="c-card-link__heading h2"> 1593 Digital mailbox and digital notification consent</span> 1594 </a> 1595 </div> 1596 </div> 1597 <div class="column small-12 medium-6 large-3" role="listitem"> 1598 <div class="l-card-grid__wrapper"> 1599 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/ENR-and-EUV-allocation/_node.html"> 1600 <span class="c-card-link__heading h2"> 1601 ENR and EUV Allocation</span> 1602 </a> 1603 </div> 1604 </div> 1605 <div class="column small-12 medium-6 large-3" role="listitem"> 1606 <div class="l-card-grid__wrapper"> 1607 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Non-submission-renewals/_node.html"> 1608 <span class="c-card-link__heading h2"> 1609 Non-submission renewals</span> 1610 </a> 1611 </div> 1612 </div> 1613 <div class="column small-12 medium-6 large-3" role="listitem"> 1614 <div class="l-card-grid__wrapper"> 1615 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Renouncements/_node.html"> 1616 <span class="c-card-link__heading h2"> 1617 Renouncements</span> 1618 </a> 1619 </div> 1620 </div> 1621 <div class="column small-12 medium-6 large-3" role="listitem"> 1622 <div class="l-card-grid__wrapper"> 1623 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Results-clinical-trials/_node.html"> 1624 <span class="c-card-link__heading h2"> 1625 Result reports of clinical trials</span> 1626 </a> 1627 </div> 1628 </div> 1629 <div class="column small-12 medium-6 large-3" role="listitem"> 1630 <div class="l-card-grid__wrapper"> 1631 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Sunset-clause/_node.html"> 1632 <span class="c-card-link__heading h2"> 1633 Sunset Clause</span> 1634 </a> 1635 </div> 1636 </div> 1637 <div class="column small-12 medium-6 large-3" role="listitem"> 1638 <div class="l-card-grid__wrapper"> 1639 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Supergrouping/_node.html">
1640 <span class="c-card-link__heading h2"> 1641 Super-grouping</span> 1642 </a> 1643 </div> 1644 </div> 1645 <div class="column small-12 medium-6 large-3" role="listitem"> 1646 <div class="l-card-grid__wrapper"> 1647 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Supply-shortages/_node.html"> 1648 <span class="c-card-link__heading h2"> 1649 Supply shortages</span> 1650 </a> 1651 </div> 1652 </div> 1653 <div class="column small-12 medium-6 large-3" role="listitem"> 1654 <div class="l-card-grid__wrapper"> 1655 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Graduated-plan-officer/_node.html"> 1656 <span class="c-card-link__heading h2"> 1657 Graduated plan officer</span> 1658 </a> 1659 </div> 1660 </div> 1661 <div class="column small-12 medium-6 large-3" role="listitem"> 1662 <div class="l-card-grid__wrapper"> 1663 <a class="c-card-link" href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/Active-substance-manufacturer/_node.html"> 1664 <span class="c-card-link__heading h2"> 1665 Active substance manufacturer</span> 1666 </a> 1667 </div> 1668 </div> 1669 </div> 1670 <div class="row"> 1671 <div class="column"> 1672 <a href="https://www.pharmnet-bund.de/PharmNet/EN/Companies/_node.html" class="c-link c-link--back"> 1673 Back to Companies</a> 1674 </div> 1675 </div> 1676 1677 </nav> 1678 </div> 1679 1680 1681 </div> 1682</div> 1683 1684<div class="c-share__wrapper"> 1685<div class="row"> 1686 <div class="small-12 medium-12 large-7 large-offset-3 column"> 1687 <div class="l-content-wrapper l-content-wrapper--bg-jade l-content-wrapper--offset-ds"> 1688 <div class="row"> 1689 <div class="column"> 1690 <div class="c-share text-right"> 1691 <div id="navFunctionsWrapper" class="navFunctionsWrapper row"> 1692 <div class="small-12 column"> 1693 <ul id="navFunctions" class="navFunctions"> 1694 <li id="navFunctionsSources" class="navFunctionsSources"> 1695 <a href="#bildnachweis-lightbox" class="bildnachweis-lightbox-opener js-bildnachweis-lightbox-opener">Photo credits</a> 1696 <div id="bildnachweis-lightbox" class="mfp-hide bildnachweis-lightbox"> 1697 <h2>Photo credits</h2> 1698 <div class="c-topiclist"> 1699 <ul class="c-topiclist__row c-topiclist__row--header c-topiclist__row--three-columns with-image row"> 1700 <li class="c-topiclist__li small-12 medium-6 large-4 column"> 1701 <div class="c-topiclist__link-wrapper with-image"> 1702 <div class="c-topiclist__a"> 1703 <div class="c-topiclist__text-wrapper"> 1704 <h4 class="c-topiclist__headline--bildnachweis"></h4> 1705 <p class="c-topiclist__p"></p> 1706 </div> 1707 <div class="c-topiclist__image-wrapper"> 1708 </div> 1709 </div> 1710 </div> 1711 </li> 1712 </ul> 1713 <ul class="c-topiclist__row c-topiclist__row--flyout row"></ul> 1714 <ul class="c-topiclist__row c-topiclist__row--content c-topiclist__row--three-columns with-image row"> 1715 <li class="c-topiclist__li small-12 medium-6 large-4 column"> 1716 <div class="c-topiclist__link-wrapper with-image"> 1717 <div class="c-topiclist__a"> 1718 <div class="c-topiclist__text-wrapper"> 1719 <h4 class="c-topiclist__headline--bildnachweis"></h4> 1720 <p class="c-topiclist__p"></p> 1721 </div> 1722 <div class="c-topiclist__image-wrapper"> 1723 </div> 1724 </div> 1725 </div> 1726 </li> 1727 </ul> 1728 </div> 1729 </div> 1730 </li> 1731 </ul> 1732 </div> 1733 </div> 1734 </div> 1735 </div> 1736 </div> 1737 </div> 1738 </div> 1739</div> 1740</div> 1741 <footer aria-labelledby="footerhead"> 1742 <h1 id="footerhead" class="aural">Footer</h1> 1743 1744 1745 1746 1747 1748 1749 1750 1751 1752 1753 1754 1755<div id="footer" class="footer footer--pharmnet"> 1756 <div class="footer__meta"> 1757 <ul class="row align-center"> 1758 1759 <li class="column shrink"> 1760 <p>© 2026 BfArM</p> 1761 </li> 1762 <li class="column shrink" 1763 1764> 1765 <a class="" href="https://www.pharmnet-bund.de/PharmNet/EN/Service-navi/Legal-notice/_node.html" 1766 1767> 1768 Legal notice</a> 1769 1770</li> 1771 1772 1773 <li class="column shrink" 1774 1775> 1776 <a class="" href="https://www.pharmnet-bund.de/PharmNet/EN/Service-navi/Privacy/_node.html" 1777 1778> 1779 Privacy policy</a> 1780 1781</li> 1782 1783 1784 <li class="column shrink" 1785 1786> 1787 <a class="" href="https://www.pharmnet-bund.de/PharmNet/EN/Service-navi/Disclaimer/_node.html" 1788 1789> 1790 Disclaimer</a> 1791 1792</li> 1793 1794 1795 <li class="column shrink"> 1796<a href="mailto:[email protected]?subject=A%20barrier%20was%20reported&body=Barrier%20on%20this%20page%3A%20%2FBfArMWeb%2FPharmNet%2FEN%2FCompanies%2FProduct-information-texts%2F_node%0A%0APlease%20describe%20briefly%20which%20barrier%20has%20occurred%20on%20this%20page." target="_blank" title="Report barrier">Report barrier</a> 1797</li> 1798 1799 </ul> 1800 </div> 1801 <div class="footer__logos"> 1802 <ul class="row"> 1803 <li class="column"> 1804 <a target="_blank" title="refer to: BfArM Homepage (Ope
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